Get documents about "IACUC eProtocol Principal Investigator “How To” Guide
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UT Health Science Center at San Antonio
Key Solutions eProtocol
IACUC eProtocol
Principal Investigator
“How To” Guide
Institutional Animal Care Program
Institutional Animal Care and Use Committee
12.17.2009 1
The UT Health Science Center uses the e-Protocol Management System created by
Key Solutions, Inc. to process human subject, animal, and safety protocols.
The e-Protocol Management System is a total web based solution that automates
the research approval processes. It is used for electronic protocol submission,
protocol routing / reviewing / tracking that will enable investigators, committee
members, and research administrators to process protocol applications online.
Note to UT Health Science Center users:
• Use your UT Health Science Center username and password.
Non-UT Health Science users – access this site for more information -
http://research.uthscsa.edu/ReplyP/replyform.asp
Resources:
• Frequently Asked Questions http://research.uthscsa.edu/eProtocol_FAQ.doc
• Download all available “How To” Guides
http://research.uthscsa.edu/eprotocol.shtml
• On-line Help Desk - http://vpr.zendesk.com
• Have Questions? support@vpr.zendesk.com, 210-567-0704
Questions about Content:
• IACUC (animal): Institutional Animal Care Program, 210-567-3718
• CSC (chemical): Environmental Health & Safety, Rebecca Bloodworth, 210-
567-2955
• IBC (biosafety): Environmental Health & Safety, Valerie Fey, 210-567-2955
12.17.2009 2
System Requirements
• Pop up Blockers and Toolbars – the system will not work properly if these
are enabled
o Turn off pop up blocker (under Tools – Pop-up Blocker - turn off)
o Disable Yahoo/Google toolbars (under View – Toolbars - uncheck
Yahoo/Google toolbars)
• Preferred browsers: Internet Explorer 7; Firefox 3; Safari 3
o IE 8 users: Under Tools, Compatibility View - select Display all
websites in compatibility view
• Virtual Memory should be setup as the computer system recommends
• Network connection (bandwidth) – recommended connection should be
100 mb
You may experience a slow response time from the eProtocol site if your system
does not meet these criteria.
Note: If the page information does not load, click Refresh/Reload.
If you experience consistently slow response time in the eProtocol site (such as
page not loading, clicking Refresh multiple times), you may contact the following:
- Cheryl Blalock, 210.567.0704
- Key Solutions, 408.990.9075
12.17.2009 3
Section 1: Logging In - https://uthscsa.keyusa.net
You will be redirected to a UT System site that requires you to select your
institution. Choose UT Health Science Center at San Antonio and click Select.
Type your UTHSCSA user ID and password and click Log In.
12.17.2009 4
The next screen will take you to the eProtocol homepage (dashboard).
The dashboard shows the status of protocols the PI has submitted for each
committee.
Make sure you have clicked on the appropriate committee tab to view your
protocols. For example, if you need to view your IACUC protocol, make sure you
have clicked on the IACUC tab.
*You will need to turn off the pop-up blocker and disable Yahoo/Google toolbars
for the system to work properly.
12.17.2009 5
You can “clone” or copy a
protocol. All content will be
Quick Summary of the Investigator Dashboard copied into a new protocol
1 Yet to Submit: with a unique protocol ID.
PI is working on the protocol.
2 Submitted:
IACP and IACUC are
reviewing the protocol.
3 Resubmit the protocol:
IACP has returned the
protocol. Open the protocol
and read the Notes. Revise as
appropriate and resubmit.
1
4 Comments:
IACUC has reviewed and
2
given comments. Click on the 3
Comments link. Respond to
the comments and revise the 5
protocol as appropriate.
Resubmit.
5 Responses:
PI has responded to the
comments and revised the
protocol. Protocol was 4
resubmitted. IACP and IACUC 7
will review the revised
protocol.
8
6 Approved:
IACUC has approved the
protocol. Open the protocol 6
and click on Event History to
view the Approval Letter.
7 Amendment
An approved protocol that
needs to be modified and
submitted.
8 Continuing Review
An approved protocol that
needs to be reviewed and
reapproved for next year.
12.17.2009 6
SECTION 2- PI GETTING STARTED
2.1 Create a new protocol
Under the eProtocol menu at the top left choose Investigator and Create Protocol.
The Investigator can also click on the ‘Create Protocol’ button.
12.17.2009 7
2.2 Name the protocol
The form below requires you to enter a study title and to choose the type of
form you need (CSC, IBC, IRB, or IACUC).
PI information will be automatically populated based on your log in information.
12.17.2009 8
2.3 Click on create
Choose the IACUC form and then click on the Create button at the top right of
the form to create the protocol.
12.17.2009 9
SECTION 3- PI Home Page
3.1 PI Dashboard
Move your mouse over the
Protocol ID to view the title.
3.2 Edit the protocol
12.17.2009 10
SECTION 4 - Protocol Application form
4.1 Personnel information
PI information will be automatically populated based on your log in information.
To add other individuals, click on the pair of binoculars.
***Note: All individuals listed under Personnel need to login to the eProtocol
system to ‘activate’ their account. Without this ‘activation,’ the individual cannot
be included in the protocol.
Click Next to continue to
next section.
Protocol contents will
automatically save.
12.17.2009 11
SECTION 4 - Protocol Application form (continued)
4.2 Species
Click on the Add button to begin adding species to the protocol form. A window
will open that will require you to specify the Species to be used. Click Save when
all of the animal information is entered. Click the “Add”
button to enter
the species
information.
Enter details about
the species and
then click “Save.”
Click on the Add button again to add additional species to the form.
12.17.2009 12
SECTION 4 - Protocol Application form (Continued)
4.3 Vet Consult
All protocols (except UTHSCSA Class A) require veterinary consultation prior to
submission. You must include the name of the vet and the date of the consult on
this page.
12.17.2009 13
SECTION 4 - Protocol Application form (Continued)
4.4 Are You Using … ?
To fill in the form you must answer the Yes/No questions and then the text fields
or Add buttons will be available or not depending on your answer.
You must respond to all items.
12.17.2009 14
SECTION 4 - Protocol Application form (Continued)
4.4 Are You Using … ? (continued)
If you answer Yes to Collaboration, Biohazard, Toxic Agents, Isotopes, or Field
Study you must click the Add button for each question and provide additional
information.
12.17.2009 15
SECTION 4 - Protocol Application form (Continued)
4.5 Funding
Click the Add button to provide additional information about your funding
sources.
12.17.2009 16
SECTION 4 - Protocol Application form (Continued)
4.6 Protocol Information
Complete all sections. Be sure to respond to every item.
If the item does not apply, respond with “N/A – not applicable.”
Depending on the data entered, new sections might come up dynamically.
Click “Next” to continue to
next section or click on the
tabs at the top of the
screen.
System will automatically
save your work.
The text fields do not allow for special characters or formatting. If you have
scientific formulas or tables/diagrams that detail the procedures and
experiments, you will need to attach these documents in the Attachments
section.
12.17.2009 17
SECTION 4 - Protocol Application form (Continued)
Procedures
Each distinct event that will occur to the animals must be entered as a separate
procedure.
Click the Add box to add each separate procedure.
12.17.2009 18
SECTION 4 - Protocol Application form (Continued)
Procedures continued
Select the procedure type (Surgery, Blood Collection, etc.).
Type a brief description.
Select the species.
The USDA pain category will auto-populate depending on the procedure type.
Indicate how many animals will be used for this procedure.
Select the location information (campus, building, room number).
Indicate the UTHSCSA Pain Category. Click the link to see the definitions.
Respond to all items. Then click the Save button.
12.17.2009 19
SECTION 4 - Protocol Application form (Continued)
Procedures continued
Depending on the procedure selected, additional items will appear under the
details section (with blue tabs).
Click through each blue tab or click the ‘Next Tab’ button. Respond to all items
for the specific procedure.
Specific blue tabs will
appear depending on the
type of procedure selected. This Next
button will
proceed to the
next blue tab
within the
Procedures
details.
12.17.2009 20
SECTION 4 - Protocol Application form (Continued)
Procedures continued
When you are finished with all the Procedure information and have answered all
questions under the blue tabs, click the Save button again. The window will
refresh back to the Procedures main page.
12.17.2009 21
SECTION 4 - Protocol Application form (Continued)
Alternatives Search
Click the Add button to include details about the literature search.
Respond to all items.
12.17.2009 22
SECTION 4 - Protocol Application form (Continued)
Materials and Methods
If you have multiple procedures, this section is required.
Describe the sequence and timing of the procedures.
Click the Add button if you have a document that provides these details.
12.17.2009 23
SECTION 4 - Protocol Application form (Continued)
Husbandry
Respond to all applicable items in the Husbandry section.
If the animals will not require any special care, indicate with “none” or “N/A not
applicable.”
To save all changes,
click “Save” for each
Husbandry section.
12.17.2009 24
SECTION 4 - Protocol Application form (Continued)
Euthanasia
Click the Add button to include details about the Euthanasia.
Respond to all applicable items.
For each species, enter the euthanasia information separately.
12.17.2009 25
SECTION 4 - Protocol Application form (Continued)
Attachments
Attach any appropriate documents under the Attachments sections.
Click the Add button
to add documents.
The text fields do not allow for special characters or formatting. If you have
scientific formulas or tables/diagrams that detail the procedures and
experiments, you will need to attach these documents in this section.
Keep in mind that the reviewers will need the appropriate software to open your
attachments so it is recommended that you limit your attachments to commonly
used software programs (Microsoft Word, Adobe PDF, etc.).
12.17.2009 26
SECTION 4 - Protocol Application form (Continued)
4.7 Guidelines
Guidelines for the protocol are determined based on the specific information
entered in the form. Some of the guidelines are mandatory and must be viewed
prior to submission. To view the details for each guideline, click on the title of
the guideline. Select “Agree” or “Request Exception.”
Depending on data
entered in protocol,
some guidelines
will be mandatory.
12.17.2009 27
SECTION 4 - Protocol Application form (Continued)
4.8 Certification
The protocol form requires certification prior to submission. Read and check the
box that certifies you have read and agree to the obligations.
Read and check
agreement
12.17.2009 28
SECTION 4 - Protocol Application form (Continued)
4.9 Event History
The Event History shows all of the activity associated with a protocol. Through
the Event History you can view all versions of the protocol and also determine
the protocol’s current status (submitted, assigned to panel, etc…).
From the Event History section, if the protocol has been approved, you can view
and print the Approval Letter.
12.17.2009 29
SECTION 4 - Protocol Application form (Continued)
4.10 Check for Completeness
Prior to submission all protocols are checked for completeness. This check can be
initiated by the user by clicking Check for Completeness from the left menu or
will occur automatically when the user submits the form. A window will open
that lists the incomplete sections. The sections can be accessed by clicking the
name of the section.
The check for completeness items must be resolved before the form can be
submitted.
12.17.2009 30
SECTION 5 - Protocol Application form – Submit the Protocol
5.1 Submit Protocol
From the menu on the left of the protocol application choose Submit Form.
You must have the protocol open in Edit mode to submit the protocol.
***Only the PI can submit the protocol.***
At this point the application is ready for viewing by the IACP office and cannot be
edited until it is returned to the PI by IACP or the IACUC committee for revisions.
12.17.2009 31
SECTION 6 - Returned Protocols - “Resubmit the Protocol”
If the protocol is returned from the IACP office, the PI will receive an e-mail
message requesting a revision and re-submission. Log-in to the e-protocol
system and open the protocol. Click on “Return Notes,” read the comments, and
make the appropriate revisions. Click Submit.
Section 7 - Comments from Reviewers - “Comments Received”
After the reviewers have submitted their comments, the IACP office will send
these comments to the PI. The PI will receive an e-mail message requesting a
revision and re-submission. Log-in to the e-protocol system.
The protocol in question will say “Comments Received.” Click on this link.
12.17.2009 32
Section 7 - Comments from Reviewers (continued)
The PI can view the comments from the reviewers. To edit the protocol, click on
the Get Protocol button and open in Edit Mode. Make the appropriate revisions,
save the protocol, and then close. The PI must type the responses AND revise the
protocol before it can be submitted.
Open protocol in
Edit Mode and
make revisions.
Comments
from reviewers.
Submit the revised
protocol AND the
responses.
PI must type
response to
every comment.
After the revised protocol and responses are submitted, the protocol event on
the homepage (dashboard) will state “Responses Sent.”
A protocol may go through several cycles of review before the IACUC reviewers
are satisfied. For each cycle, the PI must respond to the comments and revise the
protocol.
12.17.2009 33
SECTION 8 – Approved Protocols
The PI can view all Approved Protocols.
12.17.2009 34
SECTION 8 – Approved Protocols (continued)
Click on the Protocol ID and several options will appear.
To view the protocol, select View Mode. Then click on Event History to view and
print the Approval Letter.
If you need to start an Amendment (Modification) or Continuing Review
(Progress Report), click the appropriate button.
12.17.2009 35
SECTION 9 – Print View
If the protocol is open in View or Edit mode, it can be converted into a pdf file by
using the Print View function.
For Internet Explorer Users: Hold down the Ctrl and Alt keys while clicking Print
View. Keep holding these two keys until the pdf file opens.
12.17.2009 36
Section 10 - Amendment (Modification) & Continuing Review (Progress Report)
An approved protocol can be modified using the Amendment (Modification)
feature. Additionally, when an approved protocol needs to be renewed for the
next period of time (1 year, 3 years, etc.), this can be accomplished with the
Continuing Review (Progress Report) feature.
From the Investigator homepage (dashboard), scroll down to the list of Approved
Protocols. Click on the desired protocol. A window will open with several
options.
Select ‘Amendment’ or ‘Continuing Review’ and click OK.
12.17.2009 37
Amendment (Modification)
An approved protocol can be changed using the Amendment feature.
The first page (Amendment page) includes instructions detailing what kinds of
modifications are allowed.
Note: Major Modifications require the PI to submit a new protocol.
As changes are made to the protocol, these sections will show up on the
Amendment page.
Once all changes have been made, click the ‘Submit Form’ link. The protocol will
be routed to the IACP office and IACUC for review.
12.17.2009 38
Continuing Review (Progress Report)
When an approved protocol needs to be renewed for the next period of time (1
year, 3 years, etc.), this can be accomplished with the Continuing Review feature.
The first page (Continuing Review – Progress Report page) includes instructions
and specific questions about the re-approval. Respond to all appropriate items.
Sections of the protocol that have been changed will show up on this first page.
Once all changes have been made, click the ‘Submit Form’ link. The protocol will
be routed to the IACP office and IACUC for review.
12.17.2009 39
