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OC-RDC 4.5.3 iPatch Review - BioPharm Systems

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					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       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 4.5.3.25 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 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
               Server, Database Server      Clinical 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 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         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
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 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
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 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   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      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
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         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
                                              Description
System/Version Patch#   Obsolete   Priority
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    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 10648010                                       19-Jan-11      E2B

Fixing Bug 10200874                                       8-Nov-10       Aggregate Reports

                                                          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
Feature        Front End and
               Database
Features       BIP Server and
               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 one of the 2 fixes in this iPatch are
required.
Only if having issues with the Aggregate
reports
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     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 4.6.2.2 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
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 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
ARGUS 5.1      5.1.2, 10365901 None       High




ARGUS 5.1      5.1.1.1,         None      High
               10076270
ARGUS 5.1      5.1.1, 9694947   None      High




ARGUS 5.1      5.1.0.1, 9477419 None      High




ARGUS 5.1
Description                                           Problems/BUGs Addressed
Oracle Argus Safety Patch 5.1.2 contains fixes for    See readme for list of 54 bugs fixed
these Affected features




Oracle Argus Safety Patch 5.1.1.1 contains fixes to   fixing bugs 10060533
IFS - Interfaces: Case Intake.
Oracle Argus Safety Patch 5.1.1 contains fixes to     fixing Bugs 9225203, 9291307, 9321260, 9333682,
Duplicate Search, Case Form, Worklist, Argus          9333986, 9364193, 9389183, 9399966, 9400526,
Safety Services, Who Drug Dictionary, EOSU,           9444804, 9448173, 9461560, 9479315, 9492787,
PSUR/CTPR Report, SLE, Report Scheduling,             9493668, 9543548, 9546053, 9547383, 9479315,
Medical Summary Report. It also contains EU           9549374, 9558285, 9558285, 9561680, 9582039,
Device Vigilance Form updates for revision 6.         9645867, 9736320, 9662496, 9657402, 9656331,
                                                      9472484, 9464844




The system is converting the part of the URL           fixing Bugs 9221125, 9248634, 9334195
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‟.



5.1 Release
Release Date   Affected Feature    Problem Type   Components        Compatible
3-Dec-10       Reports, Case Form, Features       All Argus
               Case Actions, ESM                  Component
               Services, Worklist,                Servers
               Interfaces, Argus
               Console, Audit Log,
               Database DLP

11-Sep-10      IFS - Interfaces:   Features       Service
               Case Intake                        Components
21-May-10      Duplicate Search,   Features       All Argus
               Case Form,                         Component
               Worklist, Argus                    Servers
               Safety Services,
               Who Drug
               Dictionary, EOSU,
               PSUR/CTPR Report,
               SLE, Report
               Scheduling, Medical
               Summary Report


24-Mar-10      AG Service and     Features        Argus Safety
               Case Form                          Server and
                                                  Argus Safety
                                                  Services Server




24-Dec-09
Status/Recommendation

Only if one of the 54 fixes in this iPatch are
required.




Only if XML files that fail schema validation are
not properly moved to the Failure folder
Only if one of the 31 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 you are having the problems described
in the Description column
System/Version Patch#   Obsolete   Priority
ARGUS 6.0
Description   Problems/BUGs Addressed
6.0 Release
Release Date   Affected Feature   Problem Type   Components   Compatible
7-May-10
Status/Recommendation

				
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