october 2011 system release notes

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october 2011 system release notes Powered By Docstoc
					System/Version Patch#   Obsolete     Priority   Description
OC 4.5.1       81       None         Normal     4.5.1.81 addresses an issue with updating patient
                                                data when using password-protected user roles.
                                                Oracle Clinical displays a fatal error message
                                                when you select Update Patient Data from the
                                                Special menu.
OC 4.5.1      79        55           Normal     Patch OC_4.5.1.79 improves the performance of
                                                the PSUB process when generating Data Extract
                                                Views. This patch also includes all enhancements
                                                and repairs from the previous patches now
                                                obsolete by this patch
OC 4.5.1      76        None         Normal     4.5.1.76 This patch addresses issues in Oracle
                                                Clinical Patient Transfer and the use of password-
                                                protected user roles
OC 4.5.1      75        14, 60, 67   Normal     OC 4.5.1.75 This patch fixes an issue with
                                                updating multivariate and univariate discrepancies
                                                in Oracle Clinical and another issue with closing
                                                manual discrepancies on derived fields in RDC.
                                                This patch was originally released as OC 4.5.1.14,
                                                which provided the option to replicate
                                                discrepancies and DCFs. This is necessary to
                                                interface with the OracleLife Sciences Data Hub
                                                (LSH) application. The patch also replicates CRF
                                                page tracking tables during data replication as well.

OC 4.5.1      72        49           High       OC 4.5.1.72 This patch provides an enhancement
                                                allowing you to restrict users to specified versions
                                                of the RDC PDF Plugin. It is a companion patch to
                                                RDC PDF Plug-in Patch OC_4.5.1.69 for Bug
                                                7717518 (or later).

OC 4.5.1      69        53, 54, 64   High       4.5.1.69 This patch addresses problems with PDF
                                                data entry as invoked from the RDC 4.5.1, 4.5.3
                                                Spreadsheet Surround, or from RDC Onsite 4.5.2.
                                                It does not address these problems in Oracle
                                                Clinical 4.5.0 or Oracle Clinical NLS.



OC 4.5.1      68                     Normal     4.5.1.68 This patch prevents duplicate responses
                                                from being created during a batch data load when
                                                more than 20 question groups exist in the DCM.
                                                This patch will allow up to 40 question groups in a
                                                DCM for a DCM which is batch loaded.
OC 4.5.1   65   44, 22   Normal       4.5.1.65 This patch provides Fixes to the Maintain
                                      Study Site Security form in RDC Admin,Provides
                                      OPA Menu compatability between TMS 4.6 and
                                      OC 4.5.x by selectively hiding the TMS or OC OPA
                                      Menu,Allows the ability to direct TMS 4.5.2 report
                                      output into a user-specified directory and Prevents
                                      truncation of password verification messages.

OC 4.5.1   63   56, 41   Normal       This patch addresses a problem encountered
                         (obsoletes   when attempting to generate a DCI form after a
                         High         CPU patch is installed on the database server.
                         Priority     This patch fixes a bug and provides a new option
                         patch OC     for the controlled release PDR patch allowing
                         4.5.1.56)    suppression of overflow for hidden fields.

OC 4.5.1   62            High         *High* OC 4.5.1.62 This patch fixes a security
                                      problem with the change password forms when
                                      password rules have been associated with a profile
                                      (incuding default profile). Also fixes TMS 4.5.2 if
                                      installed on the same apps server as OC.

OC 4.5.1   61            Normal       OC 4.5.1.61 This patch for RDC PDF Data Entry
                                      removes the limit of 1000 for list of values for
                                      questions with Thesaurus DVGs.
OC 4.5.1   58   38, 30, 27,   High   OC 4.5.1.58 This patch solves data corruption
                21, 17, 5            problems in Oracle Clinical and RDC data entry.
                                     The fixes are made to the standalone DCAPI as
                                     well. This patch also fixes additional bugs in RDC.
                                     Logging of unsuccessful approval attempts to a
                                     table is introduced in this ipatch as well. This
                                     patch can be installed on 4.5.1, 4.5.2. However,
                                     the bug fixes in this patch for PDF data entry
                                     apply only to the Classic RDC Surround and
                                     not PDF data entry from RDC OnSite. Do Not
                                     Install on OC 4.5.3 - Fixes are included in
                                     4.5.3.11 & 4.5.3.12
Problems/BUGs Addressed                          Release Date   Affected Features    Problem Type
Fixing Bug 11669885                              17-Feb-11      Discrepancy Database Feature works
                                                                                     incorrectly



Fixing Bug 10144762                              9-Dec-10       Data Extract              Performance




Bug 8925493, Bug 8723259                         12-Feb-10      Oracle Clinical Patient   Feature works
                                                                Transfer, DCMs and        incorrectly
                                                                DCIs
Fixing Bug 5987723                               2-Dec-09       Procedures and Data       Feature works
                                                                Replication ,             incorrectly,
                                                                Discrepancy               Replication
                                                                Management,               enhancement
                                                                Workflow API




Fixing Bug 8256621                               26-Feb-09      RDC PDF                   Data Error




Addresses bugs 7717518 and 8243764: RDC            12-Feb-09    RDC PDF Plug-in           Feature
PDF data entry can inadvertently update checkbox
group and flag responses when you interrupt a
Save CRF operation. and 8243764 RDC PDF data
entry allows selecting F9 (display List of Values)
when focus is on a checkbox group or flag.
Incorrect data is saved when the List of Values is
used this way.
Bug 7515931: Batch data load creates duplicate     9-Jan-09     Batch Data Load           Data Error
responses if the DCM contains more than 20
question groups. Bug 6595537: Batch Data Load
fails if the patient involved has a
patient_position_id greater than 2^31 - 1
(2147483647).
Bug 6858283: When a user's password has            17-Jun-08   Maintain Study Site    Performance,
expired and the user attempts to login to OC, they             Security, OPA Menu, Functionality
are prompted to change their password. If a                    TMS 4.6 compatibility,
password verification function is in place and the             TMS 4.5.2 file viewing
password does not meet the rules, the error
message from the verification function was
truncated.

BUG 6814589: In command line Patient Data         25-Sep-07    DCI Form Generation, Functionality
Report (PDR), overflow was generated for                       Controlled Release
responses that were not visible and of type                    XMLP Patient Data
protected repeating defaults.                                  Report



BUG 6372975: Security problem with the change 24-Sep-07        Change password       Feature
password forms when a password policy has been
applied to the user profile.



BUG 4437717: RDC PDF Data Entry limits the        28-Jan-08    RDC PDF Data Entry    Feature
size of a list of values to 1000 records for
Thesaurus DVGs.
BUG 6525523: When the unique ids stored in the 4-Jun-08   Oracle Clinical Data    Functional, Data
database for CRFs, patients, discrepancies and            Entry, RDC PDF and      Corruption,
visits reach a number that is greater than                classic data entry,     Session crashes
2147483647(2^31-1), attempts to open a CRF in             Standalone DCAPI,       or hangs
PDF data entry fail with a series of form errors.         Mass Changes,
These large ids can also result in incorrect              Approvals in RDC, and
behavior in Oracle Clinical Data Entry, RDC classic       Login to RDC Classic
data entry and the standalone dcapi. Note that the        Surround.
problem ids are received_dci_id, received_dcm_id,
patient_position_id, actual_event_id and
discrepancy_entry_id. BUG 6937112: There is no
log of failed attempts to approve CRFs, where
failure is due to invalid user id or password
specification. BUG 6622271: A problem occurs
only after the compatibility portion of RDC Onsite
patch 4.5.3 is applied to the application server.
That is, if in the RDC Admin form, you define more
than one link with the same sequence number
(within the same scope) OR if you define more
than 6 links per scope, selection of the Links tab in
the RDC Classic Surround results in Error - ORA-
01422: exact fetch returns more than requested
number of rows. BUG 6356741: A problem occurs
in Oracle Clinical for a Received DCI which
includes both a repeating and a non-repeating
question group, and where the repeating question
group includes a question marked 'Pass 2 Sight
Verify = YES'. In data entry Browse mode,
responses associated with the Pass 2 Sight Verify
question are deleted by the application when an
operator comment is added or updated for a
question in the non-repeating question group.
BUG 6085187: In Oracle Clinical,when date
                                           Status/Recommendation
Components       Compatible
Application      Oracle Clinical 4.5.1 and Only if having an issue with updating patient
Server           4.5.3                     data when using password-protected user
                                           roles.


Database Server Oracle Clinical 4.5.1,     Yes, if having performance problems with
                4.5.2, and 4.5.3           generating Data Extract views or if having
                                           problems associated with the creation of new
                                           accounts that must adhere to the
                                           VERIFY_FUNCTION rules for passwords
Database         Oracle Clinical 4.5.1 and Only if having issues with Patient Transfer
Server, Forms    4.5.3                     and the use of password-protected user roles
Server
Middle-tier,     Oracle Clinical 4.5.1,    Only if having issues with updating
Server Code,     4.5.2, and 4.5.3          multivariate and univariate discrepancies in
Database                                   Oracle Clinical or with closing manual
                                           discrepancies on derived fields in RDC.




Forms Server for OC 4.5.1, OC 4.5.3        Only if required to restrict users to specified
RDC PDF          upgraded directly from    versions of the RDC PDF Plugin. This is a
                 OC 4.5.1. DO NOT          companion to iPatch 69.
                 INSTALL on OC 4.5.2 or
                 4.5.3 upgraded from
                 4.5.2
Plug-in          OC 4.5.1, OC 4.5.2 (and   Yes, if using PDF Data Entry.
                 OC 4.5.3 compatible
                 server)




Server Code      OC 4.5.1, OC 4.5.2, OC Only if using Batch Data Load and more than
                 4.5.3                  20 Question Groups exist in a DCM.
Forms Server,   OC 4.5.1, OC 4.5.2, OC Only if hitting any of the issues described in
Database        4.5.3, TMS 4.5.2, TMS description column.
Server,         4.6
Database




Forms Server,   OC 4.5.1, OC 4.5.2. DO Only if overflow was generated for responses
Database        NOT apply this patch that were not visible and of type protected
Server,         to OC 4.5.3.           repeating defaults for Patient Data Report
Database                               (PDR).



Forms Server    OC 4.5.1, OC 4.5.2.      Yes, If using password policy and applying to
                                         user profile.




Database        OC 4.5.1, OC 4.5.2, OC Only if using Thesaurus DVGs with more than
                4.5.3                  1000 records and PDF Data Entry
Forms Server,   OC 4.5.1, OC 4.5.2. DO Yes - If using Classic RDC Surround
Database        NOT apply this patch
Server,         to OC 4.5.3. Fixes are
Database        included in OC 4.5.3.11
                and OC 4.5.3.12 or any
                patch that obsoletes
                these patches
System/Version Patch#   Obsolete   Priority
OC 4.5.3       27       25         Normal




OC 4.5.3      26        24         Normal




OC 4.5.3      24        22         Normal



OC 4.5.3      25        23         Normal
OC 4.5.3   22   18          Normal




OC 4.5.3   23   21          Normal




OC 4.5.3   21   OC_4.5.3.19 High
                , (including
                OC_4.5.3.17
                ,
                OC_4.5.3.15
                ,
                OC_4.5.3.13
                ,
                OC_4.5.3.11
                ,
                OC_4.5.3.10
                ,
                OC_4.5.3.7,
                OC_4.5.3.4,
                OC_4.5.3.1,
                OC_4.5.1.58
                ,
                OC_4.5.1.38
                ,
                OC_4.5.1.30
                ,
                OC_4.5.1.27
                ,
                OC_4.5.1.17
                , and
                OC_4.5.1.5)
OC 4.5.3   19   OC_4.5.3.17 High




OC 4.5.3   18   OC_4.5.3.16 High




OC 4.5.3   17   OC_4.5.3.15 Normal




OC 4.5.3   16   OC_4.5.3.12 High
                , 13,
                OC_4.5.1.58
                , 42
OC 4.5.3   15   OC_4.5.3.11 Normal




OC 4.5.3   14   OC_4.5.3.12 High




OC 4.5.3   13   OC 4.5.3.6    High

OC 4.5.3   12                Normal
                OC 4.5.1.42, OC 4.5.1.25, OC 4.5.1.58 (including 4.5.1.38, 4.5.1.27, 4.5.1.21, and 4.5.1.17, whi




OC 4.5.3   11                Normal
                OC 4.5.3.10, OC 4.5.3.7, OC 4.5.3.4, OC 4.5.3.1, OC 4.5.1.58




OC 4.5.3   5                  Normal
OC 4.5.3   3   Normal


OC 4.5.3   2   High
Description
OC 4.5.3.27 Patch OC_4.5.3.27 fixes the following problems: A
DCM question with a Thesaurus DVG no longer sorts properly after
you apply patch OC_4.5.3.25, The Patient Data Report, the Ancillary,
Appendix, and Deleted CRFs report pages display the page number
on the first page only. The page numbers for the subsequent pages
are missing.
, The character Patient Data Report fails if a DCM has multiple
subset layouts and one of the subset layouts has a question group
with the LINES_PER_ROW value as null.
, Character layouts are modified as a result of running the Fix script
for Bug 8601231 in patch OC_4.5.3.25, This patch also includes all
enhancements and repairs from the previous patches now obsolete
by this patch.
OC 4.5.3.26 Patch OC_4.5.3.26 addresses: An issue where the
Patient Data Report and the Blank Casebook Report fail to generate
if the LINES_PER_ROW value in a DCM Question Group is null, An
issue where character layouts are modified as a result of running the
Fix script for Bug 8601231 in patch OC_4.5.3.25. This patch also
includes all enhancements and repairs from the previous patches
now obsolete by this patch.
4.5.3.24 Enhancement that lets you embed the full character set for
each Type 1 font in the PDR, plus a fix for where OC saves an
incorrect modification time stamp when you update DCI Books or
CPEs, and fixes from obsoleted patches
OC 4.5.3.25 includes the following enhancements and fixes to the
Patient Data Report (PDR): Provides a complete audit history for
each field by adding the name of the user who created the CRF and
the creation date. Fixes a problem where the Patient Data Report
does not generate and print all the CRFs. Supports a new
parameter that lets you include the approval history when printing the
Patient Data Report from the command line. Reorders the By Visit
and By Domain bookmarks.             In addition, this patch fixes
problems where RDC Onsite:         Occasionally did not set
compatibility mode for Internet Explorer 8 even after the installation
of patch OC_4.5.3.17. Moved the cursor to an incorrect field when
you saved the CRF.        Displayed an incorrect assigned Site
Investigator on the Study and Site Summary Report page.
Displayed an error and did not let you edit a DVG field if the
thesaurus DVG is defined such that two columns with different labels
are mapped as the same column.
Finally, this patch fixes problems that occur when the PC setting for
Regional and Language Options is set to Hebrew. The Home page
buttons are no longer grayed out; the Study and Site Summary
Report page no longer opens with overlapping text. This patch
4.5.3.22 Patch OC_4.5.3.22 includes the following enhancements
and fixes to the Patient Data Report (PDR):     Provides a complete
audit history for each field by adding the name of the user who
created the CRF and the creation date. Fixes a problem where the
Patient Data Report does not generate and print all the CRFs.
Supports a new parameter that lets you include the approval history
when printing the Patient Data Report from the command line.
Fixes an error that occurs when you generate a Patient Data Report
or a Blank Casebook Report that has a large amount of data.
This patch also includes all enhancements and repairs from the
previous patches now obsolete by this patch

OC 4.5.3.23: This patch includes a number of fixes in RDC Onsite
and Classic. It addresses four critical issues:Locking users accounts
only when the maximum login attempt is exceeded, Adding a new
visit page with a period in the DCI Short name, Opening Discrepancy
Details window with special characters in the discrepancy
description, Displaying the correct patient icon in the Activity List
Tree.. This patch also includes all enhancements and repairs from
the previous patches now obsolete by this patch

4.5.3.21 This patch includes repairs for RDC Onsite and the Patient
Data Report or Blank Casebook report and one repair for PDF Data
Entry. It addresses four critical problems:        Intermittent failures
of group approvals and verifications
Intermittent failures opening a data entry window from a Review
page navigated from a Home Page activity
Invalid status set for blank CRFs
Problems with test mode privileges . Another repair fix addresses an
issue with discrepancy management in RDC Onsite when resolving
manual discrepancies in a repeating question group.

Finally, this patch introduces support for database time zone named
locations. This patch also includes all enhancements and repairs
from the previous patches now obsolete by this patch.

Compatibility: OC 4.5.3 only. DO NOT install on OC 4.5.1 or OC
4.5.2.

Note 1: Patch OC_4.5.3.21 obsoletes patch OC_4.5.3.19. If you
have not installed patch OC_4.5.3.11 or any of its superceding
patches (OC_4.5.3.15, OC_4.5.3.17 or OC_4.5.3.19), you must
immediately follow installation of 4.5.3.21 with a companion patch.
The companion patch is 4.5.3.18 (which superceded 4.5.3.12,
4.5.3.14, and 4.5.3.16).

Patch OC_4.5.3.21 includes components for the database and
AS10gR2 application server. Patch OC_4.5.3.18 includes
components for the 9iAS application server and the AS10gR1 report
server.
Patch OC_4.5.3.19 obsoletes patch OC_4.5.3.17. If you did not
install patch OC_4.5.3.17 (which is required for 4.5.3.15), you must
install patch OC_4.5.3.19 in conjunction with patch OC_4.5.3.16
or the latest patch that obsoletes patch OC_4.5.3.16. Patch
OC_4.5.3.19 includes components for the database and AS10gR2
application server. Patch OC_4.5.3.16 includes components for the
9iAS application server and the AS10gR1 report server. After you
apply patch OC_4.5.3.19 and patch OC_4.5.3.16, do not apply any of
the obsolete patches listed above

This patch improves the performance when generating a large
Patient Data Report or Blank Casebook Report. In addition, patch
OC_4.5.3.18 includes all the bug fixes in the patches obsolete by this
patch, including patch OC_4.5.3.14, which provides a Find script to
address data issues that may have been introduced with the use of
group activities (for example, Approve or Verify) from the Activity list
in Remote Data Capture Classic Surround (not RDC Onsite). It also
includes fixes regarding the Mass Changes form; the Validate and
Apply options execute as expected if the change reason is greater
than 14 characters. New registry variable is provided to specify any
mapped drive in UNC format as the location for the key file

OC4.5.3.17 RDC Onsite 4.5.3 support for IE8 for HTML data entry.
In addition, this patch fixes issues related to the Patient Data Report,
middle tier memory usage, approval and verification counts, and
study site summary performance. Note: Oracle Forms does not
support Internet Explorer 8. Oracle Clinical or RDC Classic users
must use IE 6 or IE 7. For more information, see Tech Stack Note
180430.1
High* OC 4.5.3.16 This patch fixes a problem in the Patient Data
Report where checkboxes were shown as checked when the
response value was 0. Therefore, all customers should install this
patch. This patch also provides changes to the way bookmarks were
generated in the Patient Data Report. In addition, patch
OC_4.5.3.16 includes all the bug fixes in the patches obsolete by this
patch, including patch OC_4.5.3.14, which provides a Find script to
address data issues that may have been introduced with the use of
group activities (for example, Approve or Verify) from the Activity list
in Remote Data Capture Classic Surround (not RDC Onsite). It also
includes fixes regarding the Mass Changes form; the Validate and
Apply options execute as expected if the change reason is greater
than 14 characters.
OC 4.5.3.15 This patch allows you to customize the RDC Onsite
application to include an additional patient-level search field on the
Home page and the Casebooks page. This patch also fixes several
bugs relating to performance problems. Patch OC_4.5.3.15
obsoletes patch OC_4.5.3.11. If you did not install patch
OC_4.5.3.11, you must install patch OC_4.5.3.15 in conjunction with
patch OC_4.5.3.12 or the latest patch that obsoletes patch
OC_4.5.3.12. Patch OC_4.5.3.15 includes components for the
database and AS10gR2 application server. Patch OC_4.5.3.12
includes components for the 9iAS application server and the
AS10gR1 report server. Contact Oracle Support if you intend to
apply this patch in a replicated environment. After you apply patch
OC_4.5.3.15 and patch OC_4.5.3.12, do not apply any of the
obsolete patches listed above.
DO NOT install on OC 4.5.1 or OC 4.5.2

High* OC 4.5.3.14: This patch provides a code fix & a Find script to
address data issues that may have been introduced with the use of
group activities (for example, Approve or Verify) from the Activity list
in RDC Classic Surround



OC 4.5.3.13 This patch fixes performance issues with RDC Onsite
4.5.3.
OC 4.5.3.12 Companion patch to OC 4.5.3.11 that introduces a new
set of controls for the Form Version Migration function in OC. This
patch includes components for the 9iAS application server and the
AS10gR1 report server. Note 1: You must install patch OC 4.5.3.12
in conjunction with patch OC 4.5.3.11. Note 2: Do NOT install
patch OC 4.5.3.11 in a replicated environment. At a future date, this
patch will be replaced by a patch that can be applied to a replicated
environment. Note 3: The 4.5.1 i-patches namely OC 4.5.1.58, OC
4.5.1.42 and OC 4.5.1.25 are obsoleted only in 4.5.3 environment.
These are still valid in 4.5.1 and 4.5.2 environments

OC 4.5.3.11 This patch introduces a new set of controls for the Form
Version Migration function in OC that allow you to specify whether or
not Verifications and Approvals for migrated CRFs should be
reversed or retained. Note 1: You must install patch OC 4.5.3.12 in
conjunction with patch OC 4.5.3.11.
Note 2: Do NOT install patch OC 4.5.3.11 in a replicated
environment. At a future date, this patch will be replaced by a patch
that can be applied to a replicated environment.
Note 3: The 4.5.1 i-patches namely OC 4.5.1.58, OC 4.5.1.42 and
OC 4.5.1.25 are obsoleted only in 4.5.3 environment. These are still
valid in 4.5.1 and 4.5.2 environments
OC 4.5.3.5 This patch solves a problem that occurs when graphic
layouts that were created in OC 4.5.0 are copied. DO NOT install on
OC 4.5.1 or OC 4.5.2
OC 4.5.3.3 This patch allows an RDC Admin to assign privileges to
a user for multiple sites in a frozen study. DO NOT install on OC
4.5.1 or OC 4.5.2
*High* OC 4.5.3.2 This RDC Onsite patch improves performance for
opening a CRF, review discrepancies, and opening discrepancy
navigator.
Problems/BUGs Addressed   Release Date   Affected Features
Fixing Bug 10295042       18-May-11      RDC Onsite, Patient Data
                                         Report




Fixing Bug 11841736       18-May-11      Patient Data Report,
                                         character layouts




Fixing Bug 9099620        9-Feb-11       Patient Data Report



Fixing Bug 9446600        23-Sep-10      RDC Onsite, Patient Data
                                         Report
Fixing Bug 9693921                           23-Sep-10   Patient Data Report,
                                                         Blank Casebook Report




Bug 9156336, Bug 9011921, Bug 8418162, Bug   12-Feb-10   RDC Onsite 4.5.3, RDC
6855420, Bug 6811143                                     Classic Surround




Fixing Bug 8935438                           15-Dec-09   RDC 4.5.3
Fixing Bug 7510806   10-Aug-09   RDC Onsite 4.5.3




Fixing Bug 8808463   12-Jan-10   Patient Data Report




Fixing Bug 8408398   25-Jun-09   RDC Onsite 4.5.3




Functional           3-Jun-09    Patient Data Report
                                 (current). Previous:
                                 OC_4.5.3.14:
                                 Approve/Verify changes
                                 to Form Version
                                 migration, RDC Classic
                                 Surround, and Lab
                                 Assignment Criteria. OC_
                                 4.5.1.58 and obsolete
                                 patches: Oracle Clinical
                                 Data Entry, RDC PDF
                                 and classic data entry,
                                 Standalone DCAPI, Mass
                                 Changes, Approvals in
                                 RDC, and Login to RDC
                                 Classic Surround.
                                 OC_4.5.1.42: Lab
                                 Assignment Criteria.
                                 OC_4.5.1.25: Form
                                 Version Migration
Fixing Bug 8197434                                   19-Mar-09     RDC Onsite, OPA Admin




Fixing Bug 8271954: The complete                       17-Mar-09   Approve/Verify changes
implementation of this bug fix requires the                        to Form Version
application of two patches: this patch (that is, patch             migration and RDC
OC_4.5.3.14) plus patch OC_4.5.3.11 or any patch                   Classic Surround
that obsoletes that patch.


Fixing Bug 7620281                                   9-Jan-09      RDC Onsite

Fixing Bug 7373966. Bug 7291564. Bug 4203720 6-Oct-08              Approve/Verify changes
                                                                   to Form Version
                                                                   migration and RDC
                                                                   Classic Surround




Fixing Bug 6061184                                   6-Oct-08      RDC Onsite, OPA Admin




Fixing Bug 6770974                                   12-Mar-08     Graphical Layout Editor
Fixing Bug 6644211, Bug 6738493, Bug 6701471   14-Mar-08   RDC Admin, Upgrade
                                                           utility for existing DCI
                                                           Form Versions
Fixing Bug 6762991, Bug 6780422                7-Feb-08    RDC Onsite
Problem Type   Components                    Compatible
Functional     RDC Onsite Application        Oracle Clinical 4.5.3 only. Do not install on Oracle Clinical
               Server, Database Server       4.5.1 or Oracle Clinical 4.5.2




Functional     Application Server, Reports   Oracle Clinical 4.5.3 only. Do not install on Oracle Clinical
               Server, Database Server       4.5.1 or Oracle Clinical 4.5.2




Functional     Application Server, Reports   Oracle Clinical 4.5.3 only. Do not install on Oracle Clinical
               Server, Database Server       4.5.1 or Oracle Clinical 4.5.2


Functional     RDC Onsite Application        Oracle Clinical 4.5.3 only. Do not install on Oracle Clinical
               Server, Database Server       4.5.1 or Oracle Clinical 4.5.2.
Functional   Application Server, Reports Oracle Clinical 4.5.3 only. Do not install on Oracle
             Server, Database Server     Clinical 4.5.1 or Oracle Clinical 4.5.2.




Feature      RDC Onsite Application       Oracle Clinical 4.5.3 only. Do not install on Oracle
             Server, Database Tier        Clinical 4.5.1 or Oracle Clinical 4.5.




Functional   AS10gR2 Server, Database Oracle Clinical 4.5.3 only. Do not install on Oracle
             Tier                     Clinical 4.5.1 or Oracle Clinical 4.5.2. Patch OC_4.5.3.21
                                          obsoletes patch OC_4.5.3.19. If you have not installed patch
                                          OC_4.5.3.11 or any of its superceding patches (OC_4.5.3.15,
                                          OC_4.5.3.17 or OC_4.5.3.19), you must immediately follow
                                          installation of 4.5.3.21 with a companion patch. The
                                          companion patch is 4.5.3.18 (which superceded 4.5.3.12,
                                          4.5.3.14, and 4.5.3.16).
Functional   AS10gR2 Server, Database     Oracle Clinical 4.5.3 only. Do not install on Oracle Clinical
                                          4.5.1 or Oracle Clinical 4.5.2




Functional   9iAS and AS10gR1 (9.0.4.3)   Oracle Clinical 4.5.3 only. DO NOT install on Oracle
             Server                       Clinical 4.5.1 or Oracle Clinical 4.5.2.




Functional   AS10gR2 Server, Database     Oracle Clinical 4.5.3 only. DO NOT install on Oracle
                                          Clinical 4.5.1 or Oracle Clinical 4.5.2.




Functional   9iAS and AS10gR1 (9.0.4.3)   Oracle Clinical 4.5.3 only. DO NOT install on Oracle
             Server                       Clinical 4.5.1 or Oracle Clinical 4.5.2.
Functional    AS10gR2 Server, Database     OC 4.5.3 only. DO NOT install on OC 4.5.1 or OC 4.5.2




Functional    9iAS and AS10gR1 (9.0.4.3)   OC 4.5.3: DO NOT install on OC 4.5.1 or OC 4.5.2
              Server




Performance   Database Server, Database    OC 4.5.3

Functional    9iAS and AS10gR1 (9.0.4.3)   OC 4.5.3: DO NOT install on OC 4.5.1 or OC 4.5.2
              Server




Functional    AS10gR2 Server, Database     OC 4.5.3 - DO NOT install on OC 4.5.1 or OC 4.5.2




Functional    9iAS Forms Server            OC 4.5.3 - DO NOT install on OC 4.5.1 or OC 4.5.2
Functional    9iAS Forms Server, Database OC 4.5.3 - DO NOT install on OC 4.5.1 or OC 4.5.2


Performance   Database                     OC 4.5.3
Status/Recommendation
Only if having the problems described in the
Description column or the issues described for
iPatch 25




Only if having the problems described in the
Description column or the issues described for
iPatch 24




Only if you are having the problems described in
the Description column


Only if having the problems described in the
Description column or the issues described for
iPatch 23
Only if having the problems described in the
Description column or the issues described for
iPatch 18




Only if you are having the problems described in
the Description column




If you are experiencing Intermittent failures of
group approvals and verification, Intermittent
failures opening a data entry window from a
Review page navigated from a Home Page
activity, Invalid status set for blank CRFs, or
Problems with test mode privileges. If you have
not installed iPatch OC_4.5.3.17 and plan on
using Internet Explorer 8 for RDC/Onsite HTML
Data Entry. Note: RDC Classic will not work with
IE 8. RDC Classic only works with IE 6 and 7.
If you have not installed iPatch OC_4.5.3.17 and
plan on using Internet Explorer 8 for RDC/Onsite
HTML Data Entry. Note: RDC Classic will not
work with IE 8. RDC Classic only works with
IE 6 and 7.




If you are having problems with performance
when generating a large Patient Data Report or
Blank Casebook Report.




If using Internet Explorer 8 for RDC/Onsite HTML
Data Entry. Note: RDC Classic will not work
with IE 8. RDC Classic only works with IE 6
and 7.



Only if having the problem with the checkboxes
not being seen.
Must be Installed if iPatch 14 was installed.
Only if you need to customize the RDC Onsite
application to include an additional patient-level
search field on the Home page and the
Casebooks page. Also Requires iPatch 14




Only if having data issues that may have been
introduced with the use of group activities (for
example, Approve or Verify) from the Activity list
in RDC Classic Surround. Also Requires iPatch
15


Only if having performance issue with Onsite

Only if there is a requirement for controls of the
Form Version Migration function. Also Requires
iPatch 11




Only if there is a requirement for controls of the
Form Version Migration function. Also Requires
iPatch 12




Only if it is necessary to use Layouts created in
OC 4.5.0
Only if there is a requirement to allow an RDC
Admin to assign privileges to a user for multiple
sites in a frozen study.
Only if having performance issue with Onsite
System/Version Patch#   Obsolete   Priority
OC 4.6         30       27         High




OC 4.6        27        23         Normal



OC 4.6        26        None       Normal


OC 4.6        23        19         Normal



OC 4.6        14        None       High


OC 4.6        12        8          Normal



OC 4.6        21        None       Normal


OC 4.6        10        None       Normal




OC 4.6        19        17         Normal



OC 4.6        17        15         Normal


OC 4.6        15        13         Normal
OC 4.6   13   9      Normal




OC 4.6   11   None   Normal


OC 4.6   9    7      High




OC 4.6   8    2      High




OC 4.6   7    3      Normal




OC 4.6   6    None   Normal

OC 4.6   5    None   High



OC 4.6               High


OC 4.6               High
OC 4.6   Normal
Description
OC4.6.0.30 This patch fixes security vulnerabilities and issue where
an error occurs when modifying DCM Question Group Name, and
provides improved online help. This patch also includes fixes from
previous patches now obsoleted by this patch.

4.6.0.27 This patch fixes issues in Patient Data Report & Blank
Casebook Report and problems with entering passwords & changing
passwords in RDC Classic. This patch also includes fixes from
previous patches now obsoleted by this patch.
4.6.0.26 This patch fixes a problem where DCI Pages, Interval
Rules, or DCI Rules cannot be added into the Enhanced DCI Book
form.
4.6.0.23 This patch fixes issues in RDC Onsite, including issues
related to blank flag behavior and fields with no visual appearance.
This patch also includes fixes from previous patches now obsoleted
by this patch.
4.6.0.14: This patch fixes several issues that cause Oracle Clinical
4.6 not to work with Oracle Java Runtime Environment (JRE),
Standard Edition, Version 1.6, Update 19 or later.
4.6.0.12: This patch fixes issues with the DCM Graphic Layout
Editor, RDC Onsite data entry, Oracle Clinical 2nd pass data entry,
and unsigned jar files. This patch also includes fixes from previous
patches now obsoleted by this patch.
4.6.0.21 This patch fixes an issue with RDC Onsite where the
Review Discrepancies page does not display any discrepancies even
though discrepancies exist
OC4.6.0.10 This Patch has UI fixes where values were incorrectly
displayed in OC for: Lab range Effective Start & End dates, The Prov
DCI Form Generated? chkd when DCI layout/form generated and
fields on Maintain Treatment Pattern window.

4.6.0.19 This patch fixes an issue with page numbering on the
ancillary data pages of the Patient Data Report and an issue with
executed validation procedures' not populating the discrepancy
database appropriately in test mode.
This patch has fixes for the following: - three RDC Onsite
performance issues. - a problem where the group approval and
group verification processes in RDC Onsite sometimes fail.
4.6.0.15 This patch provides support for Internet Explorer 8 on
Microsoft Windows 7 for the Oracle Clinical application, the Oracle
Clinical Remote Data Capture Classic (RDC Classic) application, the
RDC Administration application, and the Upgrade utility for
generating report templates and forms
4.6.0.13 Patch OC_4.6.0.13 fixes the following problems in the
Remote Data Capture Onsite (RDC Onsite) application: If a DCM
is set up with an indicator question and if that question is not
collected in the study, you cannot enter data into the CRF.      If the
Internet Explorer Options to AutoComplete passwords is enabled,
the RDC Onsite Login page prompts you to save your password. In
a multi-page CRF in RDC Onsite, pressing the Tab key does not
work properly.
.6.0.11 This patch improves the performance time when opening
CRFs in the Oracle Clinical Remote Data Capture Onsite 4.6
(RDC Onsite 4.6) application.
OC 4.6.0.9 This patch provides an enhancement — the Extended
Text field — for RDC Onsite. The Extended Text field provides
support for lengthy comments and narratives, such as patient case
history or serious adverse events. With the new Extended Text field,
you can include all pertinent information relating to patient data in the
Oracle Clinical database as well as in Patient Data Reports and
customized reports.
OC 4.6.0.8 This patch provides an enhancement — the Extended
Text field — for RDC Onsite. The Extended Text field provides
support for lengthy comments and narratives, such as patient case
history or serious adverse events. With the new Extended Text field,
you can include all pertinent information relating to patient data in the
Oracle Clinical database as well as in Patient Data Reports and
customized reports.
4.6.0.7 This patch addresses the following issues found in the Oracle
Clinical 4.6 and Oracle Clinical Remote Data Capture Onsite 4.6
(RDC Onsite 4.6) applications: Performance time when logging in to
RDC Onsite is not optimal. Generating a Patient Data Report fails if
you are using a check box DVG with a DCM Qualifying Question and
the Qualifying Value is more than one character long. RDC Onsite
lists duplicate entries in the Study and Site field when you replace the
investigator for the site. The DCI Form Version Migration process
runs in a continuous loop.

4.6.0.6 fixes an error that occurs when you add a site to a study if the
site name contains at least one extended ASCII character.
4.6.0.5 This patch fixes a problem with batch data load when null
(blank) values are entered for fields (for example, the VALUE_TEXT
field) in the data file.

4.6.0.2 This patch improves the performance when generating a
large Patient Data Report or Blank Casebook Report

4.6.0.1 This patch includes an upgraded version of UIX. Note: RDC
Onsite supports Internet Explorer 8 (IE8). However, Oracle Forms
does not support IE 8, so Oracle Clinical and RDC Classic users
must use IE 6 or IE 7.
4.6.0 This patch includes more efficient support for handling protocol
amendments via group DCI Book Assignment; support for role based
DCI access restrictions in RDC; in page branching based on
response values and several changes to the Patient Data Report
(PDR).
Scalability and performance of the applications has been addressed
to ensure continued success of the products in the field. This release
introduces handling for same-time background processing and data
capture activities, minimizing conflicts and record locking in
environments where data entry is performed on a 24x7 basis. The
release also optimizes the utilization of middle tier resources. Finally,
Oracle Clinical & Remote Data Capture 4.6 adds handling for
intermittent connectivity loss that allows the application to continue
with minimum disruption to the users.

The 4.6 release includes significant upgrades to the technology
stack, leveraging more up-to-date capabilities and tools and
alleviating end-of-support windows for legacy components.
Problems/BUGs Addressed       Release Date   Affected Features
Fixing Primary Bug 12988587   17-Oct-11      Online help




Fixing Bug 12597083           23-Aug-11      Patient Data Report,
                                             Blank Casebook Report,
                                             passwords in RDC
                                             Classic
Fixing Bug 10150508           28-Jul-11      Enhanced DCI Book


Fixing Bug 10237180           6-Jul-11       RDC Onsite data entry,
                                             login


Fixing Bug 9903418            30-Jun-11      Technology stack


Fixing Bug 9544628            6-Jul-11       DCM Graphic Layout
                                             Editor, data entry, JAR
                                             files

Fixing Bug 12529864           11-May-11      Reviewing discrepancies


Fixing Bug 9434324            6-Apr-11       Labs, Treatment
                                             Patterns, DCIs



Fixing Bug 11707339           23-Mar-11      Patient Data Report,
                                             Discrepancy Database


Fixing Bug 10216514           25-Jan-11      RDC Onsite


Fixing Bug 9386263            28-Dec-10      Oracle Clinical, RDC
                                             Classic, DCI Form and
                                             Report Templates
Fixing Bug 10106210   3-Nov-10    RDC Onsite Data Entry




Fixing Bug 10091663   14-Sep-10   RDC Onsite


Fixing Bug 9880993    27-Sep-10   RDC Onsite Data Entry,
                                  Patient Data Report




Fixing Bug 9965184    27-Sep-10   RDC Onsite Data Entry,
                                  Patient Data Report




Fixing Bug 9317934    12-Aug-10   RDC Onsite, Patient Data
                                  Report, DCI Form
                                  Version Migration




Fixing Bug 9352351    30-Jun-10   Oracle Clinical

Fixing Bug 9363757    25-Mar-10   Batch Data Load



Fixing Bug 8565118    12-Jan-10   Patient Data Report


                      14-Jan-10
Bug Identifier: 8693171   5-Nov-09
Problem Type      Components                     Compatible
Functional,       Application Server, Database   Oracle Clinical 4.6.0, Remote Data Capture 4.6.0
security          Server, Database, Reports
                  Server


Feature problems Application Server, Database    Oracle Clinical 4.6.0, RDC 4.6.0. If you are using Oracle
                 Server, Database, Reports       Thesaurus Management System with Oracle Clinical, you
                 Server                          must install patch TMS_4.6.1.30 in conjunction with patch
                                                 OC_4.6.0.30
Feature problem   Application Server, Database   Oracle Clinical 4.6.0
                  Server, Database

Functional        Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
                  Server, Database


Technology stack Application Server              Release 4.6.0; except NOT compatible with RDC Classic


Functional        Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
                  Server, Database


Feature           Database Server, Database      Oracle Clinical 4.6.0, RDC 4.6.0


Feature           Application Server             Release 4.6




Feature           Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
                  Server, Database


Performance,      Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
feature problem   Server, Database

Functional        Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
                  Server, Database
Feature         Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
                Server, Database




Performance     Database                       Oracle Clinical 4.6.0, RDC Onsite 4.6.0


Feature         Application Server, Database   Oracle Clinical 4.6.0, RDC 4.6.0
enhancement     Server, Database




Feature         Application Server             Oracle Clinical 4.6.0, RDC 4.6.0
enhancement




Functional      Application Server, Database   Oracle Clinical 4.6.0, RDC Onsite 4.6.0
                Server, Database




Functional      Application Server             Release 4.6

Feature works   Database Servers               Oracle Clinical 4.6
incorrectly


Performance     Application Server: olsapdr.jar Release 4.6


                                               Release 4.6
Enhancement   Application Server, Reports   Release 4.6
              Server, Database Server,
              Database
Status/Recommendation

If having the problems described in the
Description column



If having the problems described in the
Description column


If having the problems described in the
Description column

If having the problems described in the
Description column


If having the problems described in the
Description column

If having the problems described in the
Description column


If having the problems described in the
Description column

If having the problems described in the
Description column



If having the problems described in the
Description column


If having RDC Onsite performance issues or if
the group approval and group verification
processes in RDC Onsite sometimes fail.
If using Internet Explorer 8 on Microsoft Windows
7 for the Oracle Clinical application, the Oracle
Clinical Remote Data Capture Classic (RDC
Classic) application, the RDC Administration
application, and the Upgrade utility for generating
report templates and forms
If having the problems described in the
Description column




If having the problems described in the
Description column

If having the problems described in the
Description column or the issues described for
iPatch 7




If having the problems described in the
Description column or the issues described for
iPatch 2




If having the problems described in the
Description column or the issues described for
iPatch 3




If performing Batch Data Loads for a patient and
a record with a blank field which is followed by a
record with values for the same field

Only if having performance issues when
generating a large Patient Data Report or Blank
Casebook Report
If requiring RDC 4.6.0 to be compiled and
certified on UIX 2.3.6.6
System/Version Patch#   Obsolete   Priority
OC 4.6.2
Description
This is a Generally Available release which is obtainable via
EDelivery or from the Oracle Store
Problems/BUGs Addressed   Release Date   Affected Features
                          Apr-11
Problem Type   Components   Compatible
Status/Recommendation
System/Version Patch#     Obsolete   Priority
OC 4.6.3       12741714              Normal
               (OC_4.6.3)
Description
4.6.3 has fwd-ported bug fixes from OC & RDC patches 4.5.1.79,
4.5.1.81, 4.5.3.24, 4.5.3.26, 4.5.3.27, 4.6.0.10, 4.6.0.12, 4.6.0.14,
4.6.0.17, 4.6.0.19, 4.6.0.21, 4.6.0.23, 4.6.0.27 & bug fixes that are
not included in any prior release.
Problems/BUGs Addressed                             Release Date   Affected Features
Oracle Clinical Patch Set 4.6.3 contains forward-   Sep-11         OC/RDC Data Entry,
ported bug fixes from Oracle Clinical and Oracle                   RDC Surround,
Clinical Remote Data Capture (RDC) patches                         Conditional Branching,
4.5.1.79, 4.5.1.81, 4.5.3.24, 4.5.3.26, 4.5.3.27,                  Performance, Security,
4.6.0.10, 4.6.0.12, 4.6.0.14, 4.6.0.17, 4.6.0.19,                  Data Extract Views,
4.6.0.21, 4.6.0.23, 4.6.0.27.                                      Patient Data Report,
                                                                   Discrepancies, Signed
                                                                   Jar Files, Group
                                                                   Approve/Verify, DCM
                                                                   Layout, DCI Access
Problem Type       Components                    Compatible
Data Error,        Application Server, Reports   4.6.2 (database only)
Feature Problem,   Server, Database Server,
Performance        Database
Status/Recommendation

Only if having the problems described in the
Description column
System/Version Patch#   Obsolete   Priority   Description
TMS 4.6        32       N/A        Normal     4.6.0.32 This patch is required only if you are using
                                              the Oracle Life Sciences Data Hub (Oracle LSH). It
                                              ensures that in Oracle LSH, transactions that
                                              cause a refresh of the TMS view
                                              tms_source_all_objects, do not result in an error.
                                              Note: Oracle LSH uses TMS internally for its
                                              classification system. The affected view is used
                                              only by Oracle LSH
TMS 4.6       31        4, 27      Normal     TMS 4.6.0.31 This patch fixes an issue with TMS
                                              omissions not appearing in the Distinct Verbatim
                                              Term Omission tab.
TMS 4.6       30        None       High       4.6.0.30 This patch includes an upgraded version
                                              of the UIX component of the technology stack

TMS 4.6       29        None       Normal     4.6.0.29 This patch addresses issues that occur
                                              while importing Oracle Clinical accounts into OPA
                                              accounts
TMS 4.6       28                   Normal     This patch fixes an issue in the Define Domain
                                              Dictionary form when a user with a long name
                                              created a record the record could not be modified
                                              subsequently.


TMS 4.6       27        21, 5      Normal     This patch fixes issues with DAGs. Also includes
                                              fixes for an error with applying actions to omissions
                                              and also prevents modifying an action from
                                              approve action assignments if the user do not have
                                              approve privilege. fixing Bug 6616330
TMS 4.6   26          8 High    This patch updates the OPA Admin and TMS Lite
                                Browser applications. fixing Bug 7042140




TMS 4.6   25                    This patch provides seed data used by the RDC
                                ipatch 4.5.3.10 for the new Special Listings page.
                                You need to apply this patch only if you are
                                planning to apply RDC ipatch 4.5.3.10 and plan to
                                make use of the Special Listings enhancement.

TMS 4.6   24           Normal   This patch provides find and fix scripts for orphan
                                missing_pt discrepancies that result from making a
                                derivation procedure provisional.



TMS 4.6   23   9, 1    Normal   This patch fixes a problem with the Report output
                                not showing the header for RTF layout templates
                                created in Microsoft Word 2003. fixing Bug
                                6844986
TMS 4.6   22   11      Normal   This patch improves the performance of the
                                upgrade process and fixes a failure. fixing Bug
                                6681404




TMS 4.6   20           Normal   This patch fixes missing seed data if TMS 4.6 is
                                installed with RDC 4.5.2 or RDC 4.5.3.

TMS 4.6   19           Normal   This patch improves performance of Batch
                                Reclassification in AERS
TMS 4.6   17           Normal   This patch fixes a problem that if TMS 4.6 was
                                installed on top of RDC 4.5.3, the reset password
                                functionality provided with RDC 4.5.3 would not
                                work.
Problems/BUGs Addressed                                 Release Date     Affected Feature
Bug 8272799                                                     9-Jul-10 TMS View




Bug 9408584                                                    19-Apr-10 Classify Verbatim
                                                                         Term Omissions

Bug 9011552                                                   10-Feb-10 TMS Browser, OPA
                                                                        Admin

6769758, Bug 7379083                                           21-Jan-10 User Accounts


BUG 7375702: In Define Domain Dictionary form,                  6-Oct-08 Define Domain
when user with a long name created a record the                          Dictionary
record could not be modified subsequently. The
form gave error "ORA-06502:PL/SQL: numeric or
value error: character string buffer too small".

BUG 7252971: In Classify VT Omissions form                    12-Aug-08 Classify VT
filter, if user cancelled out of the filter when the                    Omissions, Approve
cursor was on an external value field, the form                         Action Assignments
gave an error message. BUG 6616330: All tab of
Classify VT Omissions form did not restrict
ext_value and instance by dag rules. BUG
6653187: In Maintain DAG form, duplicate column
values were displayed for EXT_VALUE_1 and
EXT_VALUE_2 list of values. BUG 6653171:
When a domain and dictionary were picked as
DAG rules, and the dictionary did not belong to the
domain an error message was displayed in
Classify VT Omissions, Approve VTA, Approve
action assignments and Reclassify VTA form.
BUG 6620596: When a user was assigned two
DAGs, one with modify flag = Y and one with
modify flag = N, the user was able to modify data in
both DAGs. BUG 7015664: ASSIGNED filter
condition was not displayed at the bottom of All tab
in Classify VT Omissions, Approve VTAs and
Approve Action Assignments forms. BUG
7015646: ASSIGNED filter criteria was not
considered while querying data in All tab of Classify
VT Omissions, Approve VTAs and Approve Action
Assignments forms. BUG 7015657: All tab of
Classify VT Omissions, Approve VTAs, Reclassify
                                                        18-Jun-08 OPAAdmin and TMS
BUG 7042140: In the Terminology tab and VTA                       Lite Browser
tab of the TMS HTML Browser, if user queried                      applications
multiple terms with the same dict_content_id and
drilled down to the term details of each of the term,
the page gave an error message: JBO-25013: Too
many objects match the primary key

                                                        29-May-08




BUG 6508499: Setting a derivation procedure              2-Apr-08 Classification -
provisional hard deleted the derived response                     Omission
when batch validation is run. However, discrepancy                Management
entries stay in the database retaining the old
response id which now doesn't point to an actual
response.
BUG 6844986: Report output did not show the             17-Mar-08 OPAXDO
header for RTF layout templates created in
Microsoft Word 2003.

BUG 6681404: 1. TMS 4.6 upgrade script failed as        14-Jan-08 Reclassification
soon as it encountered an error in THI status
upgrade. 2. TMS 4.6 upgrade script failed in the
following scenerio: a) A VTA was created in predict
group A but not activated. b) Later another VTA
with the same TERM_UPPER was created in
predict group B and activated. c) Later the second
VTA was deleted in predict group A. Predict group
A was activated.
BUG 6650254: RDC 4.5.2/4.5.3 specific seed data         17-Jan-08 Install/Upgrade
was deleted when TMS 4.6 was installed after
RDC 4.5.2/4.5.3 installation.
BUG 6433742: Batch Reclassification job in AERS         30-Nov-07 Reclassification
was not performing well.
BUG 6525179: If TMS 4.6 was installed on top of         19-Dec-07 OPA
RDC 4.5.3, the reset password functionality
provided with RDC 4.5.3 would not work.
Problem Type    Components      Compatible Status/Recommendation
Feature         Database        N/A        Only if using the Oracle Life Sciences Data
                                           Hub (Oracle LSH).




Feature         Forms Server,                Only if omissions are not appearing in the
                Server,                      Distinct Verbatim Term Omission tab.
                Database
Certification   Application                  Only if using the UIX component of the
                Server                       technology stack

Functional,     Database                     Only if having issues that occur while importing
performance                                  Oracle Clinical accounts into OPA accounts

Feature         Forms Server,                Only if users with long names and can no
                Server,                      longer modify records they created.
                Database



Feature         Forms Server,
                Server,
                Database
Feature       Form Server    Only if hitting issues from BUG 7042140




                             Only if using RDC with iPatch 4.5.3.10
                             installed and plan on using the new Special
                             Listings page.



Data Error    Server code    Only if orphan missing_pt discrepancies that
              and Database   result from making a derivation procedure
                             provisional exist.



Feature       Java           Only if using MS Word to create RTF layout
                             templates


Performance   Server code    Only if hitting BUG 6681404.
              and Database




Data Error    Server code    Only if installed with RDC and having Seed
              and Database   Data issue.

Performance   Server code    Only if integrated with AERS and having Batch
              and Database   Reclassification performance issues.
Feature       Server code    Only if Password Reset functionality is not
              and Database   working in RDC 4.5.3.
System/Version Patch#   Obsolete   Priority   Description
TMS 4.6.1      30       10         High       4.6.1.30 This patch provides improved online help
                                              that fixes several security vulnerabilities and
                                              numerous documentation bugs. This patch also
                                              includes fixes from previous patches now
                                              obsoleted by this patch.




TMS 4.6.1     11        None       High       TMS 4.6.1.11 This patch fixes several issues that
                                              cause TMS 4.6.1 not to work with Oracle Java
                                              Runtime Environment (JRE), Standard Edition,
                                              Version 1.6, Update 19 or later.
TMS 4.6.1     10        6          Normal     4.6.1.10: This patch provides support for Internet
                                              Explorer 8 with Oracle Thesaurus Management
                                              System 4.6.1. As a result, this patch also enables
                                              the application to run on Windows 7.

TMS 4.6.1     8         N/A        Normal     4.6.1.8 This patch fixes three problems. It ensures
                                              that omissions are displayed in the Distinct VTO
                                              (Verbatim Term Omissions) tab even if they have a
                                              nonapproved VTA. In addition, a non-superuser
                                              can now execute queries in the Reclassify
                                              Verbatim Terms window, and performance of the
                                              "Task Allocation By Term" screen is improved.

TMS 4.6.1     7         N/A        Normal     4.6.1.7 This patch is required only if you are using
                                              the Oracle Life Sciences Data Hub (Oracle LSH). It
                                              ensures that in Oracle LSH, transactions that
                                              cause a refresh of the TMS view
                                              tms_source_all_objects, do not result in an error.

TMS 4.6.1     6         1          High       4.6.1.6 This patch enhances security.

TMS 4.6.1     4                               4.6.1.4 This patch improves performance in the
                                              Approve Action Assignments, Approve VTAs, and
                                              Task Allocation by Quantity windows. In addition,
                                              the correct user is displayed in the Created By field
                                              of the Approve VTAs window and the Unfulfillable
                                              Assignments Report now contains unfulfillable
                                              assignments for assignees with a lack of DAG
                                              access to external values
TMS 4.6.1   3   None   Normal   4.6.1.3 This patch addresses issues that occurred
                                while importing Oracle Clinical accounts into OPA
                                accounts
TMS 4.6.1   2                   4.6.1.2 This patch includes an upgraded version of
                                XDO
TMS 4.6.1   1          High     4.6.1.1 This patch includes an upgraded version of
                                UIX
TMS 4.6.1                       includes new features and an upgraded tech stack.
Problems/BUGs Addressed                       Affected Feature
                              Release Date
Fixing Primary Bug 12988599         17-Oct-11 Online help




Bug 12672042                          2-Jul-11 Technology Stack



Bug 9398459                         21-Dec-10 TMS Login




Bug 10131304                          5-Oct-10 TMS Forms




Bug 9728948                          16-Jul-10 TMS View




Bug 9616120 (9011536)               11-May-10 OPA Admin and
                                              TMS Browser
6769758, Bug 7379083                 3-Feb-10
Bug 9171740, Bug 9171752   27-Jan-10 User Accounts


                           12-Jan-10

                           14-Jan-10
Problem Type           Components                     Status/Recommendation
                                     Compatible
Functional, security   Application   TMS 4.6.1.. If   Only if you are having the problems described
                       Server,       you are using    in the Description column
                       Database      Oracle
                                     Clinical with
                                     Oracle
                                     Thesaurus
                                     Management
                                     System
                                     (TMS), you
                                     must install
                                     patch
                                     OC_4.6.0.30
                                     in
                                     conjunction
                                     with patch
                                     TMS_4.6.1.3
                                     0.
Technology Stack       Application   Release          Only if you are having the problems described
                       Server        4.6.1            in the Description column


Functional             Application                    If using Internet Explorer 8 with Oracle
                       Server                         Thesaurus Management System 4.6.1. As a
                                                      result, this patch also enables the application
                                                      to run on Windows 7.

Feature Problem and Database and     N/A              Only if you are having the problems described
Performance Fix     Application                       in the Description column
                    Server




Feature                Database      N/A              Only if you are using the Oracle Life Sciences
                                                      Data Hub (Oracle LSH).




N/A                    Application                    If you are having security concerns
                       Server
                                                      Only if you are having the problems described
                                                      in the Description column
Functional,   Database   Only if you have issues that occur while
performance              importing Oracle Clinical accounts into OPA
                         accounts
                         Only if upgraded version of XDO is required

                         Only if upgraded version of UIX is required
System/Version Patch#   Obsolete   Priority   Description
TMS 4.6.2                                     This is a Generally Available release which is
                                              obtainable via EDelivery or from the Oracle Store
Problems/BUGs Addressed                     Affected Feature
                          Release Date
                                12-May-11
Problem Type   Components                Status/Recommendation
                            Compatible
System/Version Patch#      Obsolete   Priority   Description
TMS 4.6.3      12741714                          TMS 4.6.3 contains forward-ported bug fixes from
               (TMS_4.6.3)                       TMS 4.5.2.22 and TMS 4.6.1, and some new bug
                                                 fixes that are not included in any prior release
Problems/BUGs Addressed                   Affected Feature
                          Release Date
                                 6-Sep-11 Omission
                                          Management,
                                          Repository
                                          Maintenance, VTA
                                          Maintenance,
                                          External System
                                          Definition, Verbatim
                                          Term
                                          Reclassification,
                                          TMS HTML Browser
Problem Type          Components               Status/Recommendation
                                    Compatible
Data Error, Feature   Application   4.6.2      Only if you are having the problems described
Problem,              Server,       (database  in the Description column
Performance           Database      only)
                                              Description
System/Version Patch#   Obsolete   Priority
AERS 4.6.1     29       26         High       AERS 4.6.1.29 This patch contains enhancement
                                              to aggregate report suite DSUR BIP

AERS 4.6.1    28        27, 271    High       AERS Patch 4.6.1.28 contains fixes to E2B, Front
                                              End, and Reports



AERS 4.6.1    901       None       High       AERS Patch 4.6.1.901 contains a fix to the Front
                                              End
AERS 4.6.1    271                  High       AERS 4.6.1.271 This patch contains a fix to the
                                              E2b
AERS 4.6.1    26        16         High       4.6.1.26 This patch contains fixes to the
                                              Aggregate reports
AERS 4.6.1    2501      None       High       4.6.1.2501 FRM-40735 KEY-COMMIT TRIGGER
                                              RAISED ORA-01422 WHILE SAVING A NEW
                                              CASE
AERS 4.6.1    25        24         High       4.6.1.25 This patch contains a fix to the
                                              Submission Wizard, E2B, and Front End




AERS 4.6.1    23        22         High       AERS 4.6.1.23 This patch contains fixes to the
                                              Reports, Submission Wizard, E2B, and Front End




AERS 4.6.1    22        20         High       AERS 4.6.1.22 This patch contains fixes to the
                                              E2B, Query, and Front End



AERS 4.6.1    20        19         High       AERS 4.6.1.20 This patch contains fixes to the
                                              Submission Wizard , E2B, and Front End.
AERS 4.6.1   19   18   High   AERS 4.6.1.19: This patch contains fixes to the
                              PSUR, Dictionary, E2B, Front End, and Reports.



AERS 4.6.1   18   17   High   AERS 4.6.1.18 This patch contains fixes to Front
                              End, E2B, Submission Tracking, Reports,
                              Dictionary, and Japanese Front End




AERS 4.6.1   17   15   High   AERS 4.6.1.17 This patch contains fixes to the
                              Front End, Reports, E2B, and PSUR.



AERS 4.6.1   16        High   AERS 4.6.1.16 This patch contains contains fixes
                              to the BIP PSUR and ASR.




AERS 4.6.1   15   13   High   AERS 4.6.1.15 This patch contains fixes to the
                              Front End, E2B, Global Maintenance, Reports, and
                              Online Help.



AERS 4.6.1   11        High   4.6.1.11 This patch introduces the Multi-schema
                              installation.



AERS 4.6.1   10        High   4.6.1.10 contains a new suite of Aggregate
                              Reports, including the PSUR and ASR, which have
                              been created using the BI Publisher tool


AERS 4.6.1   1         High   4.6.1.1 ERROR ORA-6508 IN FORMS

AERS 4.6.1                    4.6.1 Release
Problems/BUGs Addressed                                   Release Date   Affected Feature
fixing Bug 12715039                                       21-Jul-11      Aggregate Reporting
                                                                         Suite/DSUR

fixing Bug 12365191                                       26-Apr-11      E2B, Front End, and
                                                                         Reports



fixing Bug 8513408                                        16-Mar-11      Front End

fixing Bug 10648010                                       19-Jan-11      E2B

Fixing Bug 10200874                                       8-Nov-10       Aggregate Reports

Fixing Bug 10306025                                       22-Nov-10      Front End


                                                          7-Sep-10       Submission Wizard,
This section describes the bugs fixed in this patch.                     E2B, and Front End
For further information about the bugs, see the
Bug Database. This patch also includes fixes to
bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,
4.6.1.15, 4.6.1.17, 4.6.1.18, 4.6.1.19, 4.6.1.20,
4.6.1.22, 4.6.1.23, and 4.6.1.24 patches.


fixing Bug 8321553. This patch also includes fixes 9-May-10              Reports, Submission
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,                       Wizard, E2B, and
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,                  Front End
4.6.1.15, 4.6.1.17, 4.6.1.18, 4.6.1.19, 4.6.1.20, and
4.6.1.22 patches.




fixing Bug 6047054. This patch also includes fixes 3-Feb-10              E2B, Query, and
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,                       Front End
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,
4.6.1.15, 4.6.1.17, 4.6.1.18, 4.6.1.19, and 4.6.1.20
patches
fixing Bug 7518973. This patch also includes fixes 5-Nov-09              Submission Wizard ,
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,                       E2B, and Front End
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,
4.6.1.15, 4.6.1.17, 4.6.1.18, and 4.6.1.19 patches.
fixing Bug 6321824. This patch also includes fixes 28-Aug-09   PSUR, Dictionary,
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,             E2B, Front End, and
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,        Reports
4.6.1.15, 4.6.1.17, and 4.6.1.18 patches.

fixing Bug 6416921. This patch also includes fixes 6-May-09    Front End, E2B,
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,             Submission
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,        Tracking, Reports,
4.6.1.15 and 4.6.1.17 patches                                  Dictionary, and
                                                               Japanese Front End




fixing Bug 7385099. This patch also includes fixes 10-Apr-09   Front End, Reports,
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,             E2B, and PSUR
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, 4.6.1.13,
and 4.6.1.15 patches.

fixing Bugs 7773523: WORKING DOC HAS HARD- 24-Feb-09           ASR (BIP) and
CODED CODELIST VALUES IN PROC                                  PSUR (BIP)
REPORTTEXT.GET_MEDICALHISTORY,
7796368: BI PUBLISHER CTASR ERRORS IN
COUNTS FOR SUMMARY TABULATION,
8209719: BI PUB PSUR NON-RELATED
SOLICITED EVENTS IN HCP SUMMARY
TABULATION
fixing Bug 7587469. This patch also includes fixes 23-Feb-09   Front End, E2B,
to bugs in the 4.6.1.2, 4.6.1.3, 4.6.1.4, 4.6.1.5,             Global Maintenance,
4.6.1.6, 4.6.1.7, 4.6.1.8, 4.6.1.9, 4.6.1.12, and              Reports, and Online
4.6.1.13 patches.                                              Help


fixing Bugs 6987733: ENABLE MULTI-SCHEMA          24-Oct-08    Multi-Schema
SUPPORT FOR 4.6.1, 6858509: AERS 4.6
INSTALLATION GUIDE MENTIONS MULTI-
SCHEMA WHICH IS NO LONGER SUPPORTED

fixing Bug 6855220: CREATE A NEW PSUR             23-Jul-08    PSUR
REPORT IN BI PUBLISHER



fixing Bug 6342072: ERROR ORA-6508 IN                          Front End
FORMS
Problem Type   Components        Compatible
Enhancement    Aggregate
               Reports

Features       Forms Server,
               Reports Server,
               Server Code
               and Database

Features       Forms Server

Feature        Front End and
               Database
Features       BIP Server and
               Database
Feature        Database


Features       Forms Server,
               Reports Server,
               and Database




Features       Forms Server,     The following TMS patches have
               Reports Server,   been tested with AERS 4.6.1.23:
               Server Code,      4.6.0.2, 4.6.0.3, 4.6.0.4, 4.6.0.6,
               and Database      4.6.0.7, 4.6.0.10, 4.6.0.12,
                                 4.6.0.15, 4.6.0.19, 4.6.0.23,
                                 4.6.0.26, 4.6.0.27, 4.6.0.28.
                                 TMS patch 4.6.0.19 is also
                                 required to fix bug 6637492.

Features       Forms Server,
               Reports Server,
               Server Code,
               and Database

Features       Forms Server,
               Reports Server,
               Server Code,
               and Database
Features            Forms Server,
                    Reports Server,
                    Server Code,
                    and Database

Features            Forms Server, AERS 4.6 Base Installation
                    Reports Server,
                    Server Code,    The following TMS patches have
                    and Database been tested with AERS 4.6.2:
                                    4.6.0.2, 4.6.0.3, 4.6.0.4, 4.6.0.6,
                                    4.6.0.7, 4.6.0.10, 4.6.0.12,
                                    4.6.0.15, 4.6.0.19, 4.6.0.23,
                                    4.6.0.26, 4.6.0.27, 4.6.0.28.

                                      TMS patch 4.6.0.19 is required.

                                      10gAS 10.1.2.2 plus any
                                      additional post-patch updates


Features            Forms Server,
                    Reports Server,
                    Server Code,
                    and Database

Features            BIP Reports       .10 and .15 must be installed
                    and Database




Features            Forms Server, TMS patch 4.6.0.19 is also
                    Reports Server, required to fix bug 6637492
                    Server Code,
                    and Database


New Feature         Forms Server, You must apply 4.6.1.12 (or
                    Reports Server, later) prior to applying 4.6.1.11.
                    Server Code,
                    and Database

enhancement to the Reports Server,
PSUR and ASR       BIP Reports,
reports            Server Code,
                   and Database

Forms application   Forms Server
Status/Recommendation
Only if the fix in this iPatch is required.


Only if the fix in this iPatch is required.




Only if the fix in this iPatch is required.

Only if one of the 2 fixes in this iPatch are
required.
Only if having issues with the Aggregate
reports
Only if the fix in this iPatch is required.


Only if one of the 18 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.




Only if one of the 17 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.




Only if one of the 15 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.

Only if one of the 20 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.
Only if one of the 39 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.

Only if one of the 25 fixes in this iPatch are
required.




Only if using ASR (BIP) and PSUR (BIP)




This should be considered as a Patcheset and
applied accordingly.




Only if using Multi-schema installation




Only if using PSUR




Only if hitting BUG 6342072
System/Version Patch#         Obsolete        Priority
AERS 4.6.2     13060272                       High
               (AERS_4.6.2.60
               2)

AERS 4.6.2     12655864         4.6.2.4 and   High
               (AERS_4.6.2.6)   4.6.2.5
AERS 4.6.2     12655864         None          High
               (AERS_4.6.2.5)
AERS 4.6.2     12773880         1260340     High
               (AERS_4.6.2.4)   (AERS_4.6.2
                                .3)

AERS 4.6.2     1260340        8551221     High
               (AERS_4.6.2.3) (AERS_4.6.2
                              .2)

AERS 4.6.2     8551221        None            High
               (AERS_4.6.2.2)


AERS 4.6.2     8551221         8551221     High
               (AERS_4.6.2.1), (AERS_4.6.2
               ARU#:           )
               11363686




AERS 4.6.2     11058080         None          High
               (AERS
               4.6.2.101)

AERS 4.6.2     106488886        None          High
               (AERS
               4.6.2.003)


AERS 4.6.2     8551221          None          None
                                              Provided




AERS 4.6.2
Description                                         Problems/BUGs Addressed
AERS 4.6.2.602 This patch contains fixes to the     fixing Bug 13060272
E2B, specifically UNKNOWNDRUG IS PRINTED
WHEN ACTIVE SUBSTANCE IS NOT KNOWN
ON E2B
AERS 4.6.2.6 This patch contains fixes to Query     fixing Bug 12655864
and Front End
AERS 4.6.2.5 This patch contains enhancement to     fixing Bug 12655864
aggregate report suite
AERS 4.6.2.4 This patch contains fixes to E2b and   fixing Bug 12773880
Front End.


AERS 4.6.2.3 This patch contains fixes E2b, Front fixing Bug 12603040
End, and the Submission Wizard


AERS 4.6.2.2 This patch contains fixes to           fixing Bug 11071101
Reports, Front End and the Submission Wizard


AERS 4.6.2.1 This patch contains fixes to the BIP, fixing Bug 8620044. The 4.6.2.1 patch only
PSUR, Dictionary, E2B, Front End, Submission       contains bug fixes up to patch 4.6.1.19 (plus some
Tracking, Reports, and Japanese Front End          4.6.2 specific bug fixes). Therefore, customers
                                                   who upgrade from 4.6.1.20 or later, to 4.6.2.1, may
                                                   see some of their required bug fixes not included in
                                                   4.6.2.1, and should check the release notes for the
                                                   list of bug fixes in 4.6.2.1

AERS 4.6.2.101 This patch contains a fix to the     fixing Bug 11058080
E2b


AERS 4.6.2.003 This patch contains a fix to the     fixing Bug 10648886
E2b



Second release of Release Notes. Modification to    fixing Bug 8551221
the “Installing and Configuring BI Publisher for
AERS” section. Added step 6.




4.6.2 Release
Release Date   Affected Feature   Problem Type        Components          Compatible
7-Oct-11       E2B                Feature not working Database



12-Aug-11      Aggregate Reporting Enhancement          Aggregate
               Suite                                    Reports
12-Aug-11      Aggregate Reporting Enhancement          Aggregate
               Suite                                    Reports
28-Jul-11      E2B, Front End and Features              Database,
               Reports                                  Front End and
                                                        Reports

15-Jun-11      E2b, Front End, and Features             Front End and
               the Submission                           Database
               Wizard

8-Feb-11       Reports, Front End, Features             Forms Server,
               and the Submission                       Reports Server,
               Wizard                                   and Database

23-Feb-10      BIP, PSUR,         Features              Forms Server,
               Dictionary, E2B,                         Reports Server,
               Front End,                               BIP Server,
               Submission                               Server Code,
               Tracking, Reports,                       and Database
               and Japanese Front
               End

19-Jan-11      E2B                Features              Forms Server
                                                        and Database


19-Jan-11      E2B                Features              Forms Server
                                                        and Database



11-Jun-09      None Provided      Second release of     Forms Server,
                                  Release Notes.        Reports Server,
                                  Modification to the   Server Code,
                                  “Installing and       and Database
                                  Configuring BI
                                  Publisher for AERS”
                                  section. Added step
                                  6.
29-May-09
Status/Recommendation
Only if having the problems described in the
Description column


Only if one of the 8 fixes in this iPatch are
required.
Only if one of the 8 fixes in this iPatch are
required.
Only if one of the 14 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.
Only if one of the 36 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.
Only if one of the 44 fixes in this iPatch are
required. Or if any of the fixes in the previous
iPatches are required and that iPatch has not
been installed.
Only if having the problems described in the
Description column




Only if required to have codelist record of more
than 20 characters or if required to use the
updated E2B submission

Only if E2B tag is populated incorrectly or
required to use the updated E2B submission
or reqired to have codelist record of more than
20 characters

Second release of iPatch for Upgrade to AERS
4.6.2
System/Version Patch#         Obsolete      Priority
AERS 4.7       13060272       4.7.0.2 and   High
               (AERS_4.7.0.4) 4.7.0.3


AERS 4.7       12834813       None          High
               (AERS_4.7.0.3)
AERS 4.7       12808051       None          High
               (AERS_4.7.0.2)
AERS 4.7
Description                                        Problems/BUGs Addressed
This patch contains fixes to Front End and Reports fixing Bug 13099527



This patch contains fixes to the Reports       fixing Bug 12834813

This patch contains enhancement to aggregate   fixing Bug 12808051
report suite
4.7 Release
Release Date   Affected Feature     Problem Type         Components      Compatible
21-Oct-11      Reports, Front End / Features not working Front End and
               Configuration                             Reports


9-Sep-11       Reports             Features not working Reports

30-Aug-11      Aggregate Reporting Enhancement          Aggregate
               Suite                                    Reports
Status/Recommendation
Only if one or more of the 7 fixes in this iPatch
are required or if one of more of the 3 fixes
from iPatch 3 or the 8 fixes from iPatch 2 are
required.
Only if one or more of the 3 fixes in this iPatch
are required.
Only if one or more of the 8 fixes in this iPatch
are required.
System/Version Patch#     Obsolete   Priority   Description
ARGUS 5.1      5.1.3.1,   None       High       Oracle Argus Safety Patch 5.1.3.1 contains the
               13042349                         enhancement to Periodic Reports, specifically
                                                Performance issue in DSUR SQL for Cumulative
                                                Summary
ARGUS 5.1     5.1.3,      None       High       Oracle Argus Safety Patch 5.1.3 contains New
              12698616                          Features and fixes for Affected features




ARGUS 5.1     5.1.1.2,    None       High       Oracle Argus Safety Patch 5.1.1.2 contains fixes
              12685388                          for these Affected features
ARGUS 5.1   5.1.2,        None    High   Oracle Argus Safety Patch 5.1.2 contains fixes for
            10365901                     these Affected features




ARGUS 5.1   5.1.1.1,       None   High   Oracle Argus Safety Patch 5.1.1.1 contains fixes to
            10076270                     IFS - Interfaces: Case Intake.
ARGUS 5.1   5.1.1, 9694947 None   High   Oracle Argus Safety Patch 5.1.1 contains fixes to
                                         Duplicate Search, Case Form, Worklist, Argus
                                         Safety Services, Who Drug Dictionary, EOSU,
                                         PSUR/CTPR Report, SLE, Report Scheduling,
                                         Medical Summary Report. It also contains EU
                                         Device Vigilance Form updates for revision 6.




ARGUS 5.1   5.1.0.1,      None    High   The system is converting the part of the URL
            9477419                      entered in Addition Info field of the case form to
                                         UPPER case. When an expedited report is
                                         emailed from Argus via the Argus Safety Server
                                         using the Bulk Transmit Email process, the PDF
                                         report does not contain the custom PDF attributes.
                                         Workflow restriction for 'Privileges to Others' is not
                                         enforced. The ‘Read-only’ and ‘No Access’ options
                                         have the same effect as selecting ‘Read/Write’.



ARGUS 5.1                                5.1 Release
Problems/BUGs Addressed                        Release Date   Affected Feature
fixing bug 13036338                            4-Oct-11       Periodic Reports



7 new features and fixing 33 bugs (10309179,   29-Jul-11      AG Services, Audit
10324867, 10350776, etc.)                                     Log, Case Form,
                                                              Common Function,
                                                              Database, E2B
                                                              Import, Mapping,
                                                              EOSU, ESM
                                                              Services, Expedited
                                                              Reports, Interchange
                                                              Incoming Reports,
                                                              LAM-Central,
                                                              Letters, Periodic
                                                              Reports, Reports,
                                                              Utilities

fixing bugs 12648499, 12637662, 12614703,      22-Jun-11      Worklist ->Bulk E2B
12592715                                                      Transmit ->
                                                              Messages (sub-tab) -
                                                              > View XML
                                                              Acknowledgment
                                                              (right click on the +
                                                              sign), Worklist -
                                                              >Bulk E2B Transmit -
                                                              > Messages (sub-
                                                              tab) -> View
                                                              Acknowledgment
                                                              (right click on the +
                                                              sign), Worklist -
                                                              >Bulk E2B Transmit -
                                                              > Messages (sub-
                                                              tab) -> View
                                                              Acknowledgment
                                                              (right click on the +
                                                              sign) -> Print,
                                                              Utilities -> E2B ->
                                                              E2B Transmit Status
                                                              -> Click on the +
                                                              sign for ACK and
                                                              Message, Utilities ->
                                                              E2B -> E2B Receive
                                                              Status -> Click on
                                                              the + sign for ACK
                                                              and Message, Case
                                                              Form -> Reg
                                                              Reports tab ->
                                                              Report Details ->
                                                              View ACK button
                                                              click ->
See readme for list of 54 bugs fixed           3-Dec-10     Reports, Case Form,
                                                            Case Actions, ESM
                                                            Services, Worklist,
                                                            Interfaces, Argus
                                                            Console, Audit Log,
                                                            Database DLP

fixing bugs 10060533                           11-Sep-10    IFS - Interfaces:
                                                            Case Intake
fixing Bugs 9225203, 9291307, 9321260, 9333682, 21-May-10   Duplicate Search,
9333986, 9364193, 9389183, 9399966, 9400526,                Case Form,
9444804, 9448173, 9461560, 9479315, 9492787,                Worklist, Argus
9493668, 9543548, 9546053, 9547383, 9479315,                Safety Services,
9549374, 9558285, 9558285, 9561680, 9582039,                Who Drug
9645867, 9736320, 9662496, 9657402, 9656331,                Dictionary, EOSU,
9472484, 9464844                                            PSUR/CTPR Report,
                                                            SLE, Report
                                                            Scheduling, Medical
                                                            Summary Report


fixing Bugs 9221125, 9248634, 9334195          24-Mar-10    AG Service and
                                                            Case Form




                                               24-Dec-09
                                                 Status/Recommendation
Problem Type        Components      Compatible
Feature not Working Argus Safety    Argus Safety Only if having the problems described in the
                    Database        5.1.3        Description column


Features           All Argus        Argus Safety If will benefit from any of the 7 new features or
                   Component        Version 5.1.2 if one of the 33 fixes in this iPatch are
                   Servers                        required.




Features           Argus Safety    Argus Safety Only if one of the 4 fixes in this iPatch are
                   Web and         Version 5.1.1 required.
                   Report Server or 5.1.1.1
                   and Argus
                   Safety Services
                   Server
Features   All Argus         Only if one of the 54 fixes in this iPatch are
           Component         required.
           Servers




Features   Service           Only if XML files that fail schema validation are
           Components        not properly moved to the Failure folder
Features   All Argus         Only if one of the 31 fixes in this iPatch are
           Component         required. Or if any of the fixes in the previous
           Servers           iPatches are required and that iPatch has not
                             been installed.




Features   Argus Safety      Only if you are having the problems described
           Server and        in the Description column
           Argus Safety
           Services Server
System/Version Patch#            Obsolete   Priority
ARGUS 6.0      6.0.3/ 12800077   None       High




ARGUS 6.0      6.0.2.1/ 12641710 None       High




ARGUS 6.0      6.0.2/ 12387547   None       High




ARGUS 6.0      6.0.1.1/ 11695449 None       High
ARGUS 6.0   6.0.1/ 10638715   None   High




ARGUS 6.0
Description                                           Problems/BUGs Addressed
Oracle Argus Safety Patch 6.0.3 contains new          New features and bug fixes
features. Fixes to the Affected features are also
available in this patch




Oracle Argus Safety Patch 6.0.2.1 contains fixes to   Bugs 12593706 and 12569268
the affected features (CANNOT GENERATE
PMDA E2B RPT SINCE SET 'NO LONGER
REQUIRED' STATUS ) (B.5.4
<SENDERCOMMENT> IN NULLIFICATION
REPORT IS NULL)
Oracle Argus Safety Patch 6.0.2 contains New          Many bug fixes and New Features: Japanese E2B
Features. Fixes to the Affected features are also     Import , Research Report Data Entry Usability
available in this patch                               Enhancement , Case Form Text Data Copy ,
                                                      Seiyakukyo Line Listing Report , Event
                                                      Reportability Rule Enhancement , Device Fields
                                                      Support in E2B Import Framework




Oracle Argus Safety Patch 6.0.1.1 contains fixes to Bug 11682223
many Affected features
Oracle Argus Safety Patch 6.0.1 contains fixes to   Many
many Affected features




6.0 Release
Release Date   Affected Feature         Problem Type            Components       Compatible
15-Sep-11      Advanced                 Added new features      Argus Safety     Argus Safety
               Conditions, Argus        and fixes to features   Web Server,      6.0.2 and
               Affiliate, Argus         not working             Argus Safety     6.0.2.1
               Console, Argus                                   Report Server,
               Interchange, Argus                               Argus Safety
               Safety Services,                                 Transaction
               Audit Log, Case                                  Server, Argus
               Actions, Case Form,                              Safety
               Dashboard,                                       Database
               Database, DLP,                                   Server
               Documentum
               Integration, EOSU
               Tool, Expedited
               Reports, Installation,
               Interfaces, Letters,
               Login, MedDRA
               Recode, Periodic
               Reports, Regulatory
               Reporting Rules,
               Reports, System
               Reports, Utilities,
               Worklist


10-Jun-11      E2B Reports              Features not working Database            Argus Safety
                                                                                 Version 6.0.2




5-May-11       Argus Console, Audit Added new features          Argus Safety     Argus Safety
               Log, Case              and fixes to features     Web/Report       Versions
               Form,Database,         not working               Server, Argus    6.0.1 or
               DLP, E2B Import                                  Safety           6.0.1.1
               Mapping, ESM                                     Transaction
               Mapping Utility, ESM                             Server, Argus
               Service, Installation,                           Safety
               Periodic Reports,                                Database
               Reporting, Reports                               Server

31-Jan-11      Batch Reports and        Features not working Argus Safety        An installed
               DLP Upgrade                                   Database            6.0 version of
                                                             Update              Argus Safety
                                                                                 plus the
                                                                                 Argus Safety
                                                                                 Version 6.0.1
                                                                                 installation
                                                                                 package
10-Jan-11   Advanced              Features not working Argus Safety   Argus Safety
            Conditions, AG                             Web            Version 6.0
            Service, Argus                             Components
            Affiliate, Argus
            Console, Audit Log,
            Case Actions, Case
            Form, Dashboards,
            Database,
            Dictionaries, DLP,
            Dossier, E2B
            Extension, E2B
            Import Mapping, End
            of Study Unblinding,
            ESM Mapping Utility,
            ESM Service,
            Expedited Reports,
            Installation, Initial
            Case Entry, Letters,
            Login, MedDRA
            Recoding, Periodic
            Reports, Regulatory
            Reporting,
            Reporting, Reports,
            System Reports,
            Utilities, Worklist



7-May-10
Status/Recommendation
If would benefit from the new features or are
having the problems in the features not
working/bug fixes




If having the problems described in the
Description column




If would benefit from the new features or are
having the problems in the features not
working/bug fixes




If having the problems described in the
Description column
If having the problems described in the
Description column
System/Version Patch Name/#     Obsolete   Priority
Argus 7.0      7.0.0.1/13004801 None       High




Argus 7.0
Description                                        Problems/BUGs Addressed
Oracle Argus Safety Patch 7.0.0.1 contains an      Feature fixing Bug 12895176, fixing Bug 13019391
enhancement to Periodic Reports and a bug fix to
the Argus Console.




7.0 Release
Release Date   Affected Feature     Problem Type   Components Compatible
8-Oct-11       Periodic Reports and Feature        Argus Safety    Argus Safety
               Installation         Enhancement    Web and         7.0
                                                   Report Servers,
                                                   Argus Safety
                                                   Services
                                                   Server, Argus
                                                   Safety Databa

15-Apr-11
Status/Recommendation
If would benefit from the new feature or are
having the problems in the features not
working/bug fixes

				
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