Protocol Application & Tracking System (PATS)
Frequently Asked Questions (FAQ)
Below is a list of Frequently Asked Questions, divided into the following sections:
General | Submission
| Applications | Conversion
| Informed Consent Documents | Progress Reports
AE = Adverse Event
CCI = Committee on Clinical Investigations
IRB = Institutional Review Board
KP = Key Personnel
MMC = Montefiore Medical Center
PR = Progress Report
PRC = Protocol Review Committee
- I forgot my username and/or password - what
should I do?
- If you forgot your username, email
If you forgot your password, click
here to request a new one.
- I want to let my secretary, research coordinator,
or student have access to my protocols in PATS.
What do I do?
- Fax (718-430-8817) or email
Sathya with a message naming the individual(s)
whom you wish to authorize as your "PATS Delegate".
NOTE: Only individuals who are trained in PATS may
be assigned as delegate. For information on PATS
- Will the MMC IRB accept the printed forms from
- What internet browser(s) can I use? I know I
need to download Internet Explorer, but how do I
- Microsoft Internet Explorer (versions 6.0-8.0)
is the only compatible browser.
IE) As no compatible version of Internet Explorer
is available on the Mac, a PC is required.
- After logging into PATS, it freezes - I can't
expand any of the menu categories (e.g. "Applications,"
"Maintenance," or "Login/Logout").
- The most likely cause of this problem is the
use of a browser other than Internet Explorer 6.0-8.0.
If you believe that this is not the problem,
confirm that you are using Internet Explorer 6.0
or higher, then contact
- I'm unable to start a new Amendment/AE/Progress
Report (or edit an existing one) even though I have
an approved protocol. What's wrong with PATS?
- There are two likely explanations:
- The transaction you are trying
to start was already started.
Solution: Try clicking on "Edit"
instead of "New"
- Your browser is caching (storing)
outdated information. Solution:
Change the Internet Explorer settings
to eliminate this problem.
Step-by-step directions for IE 8.0
- How do I find out what my CCI # is?
- As soon as you create a new application, a CCI
# is assigned. It is displayed near the top of the
application form, as well as on the printout. In
PATS, CCI #s now have a 4-digit year, but retain
the 3-digit serial number (04-123 is now 2004-123).
Numbers that follow a second hyphen (e.g. the 001
in 2004-123-001) are sequence numbers specific to
NOTE: If you submitted a grant to the CCI for a
"Pending" signature, we will have assigned a CCI
# for you. Look for the CCI # on the CCI Grant Application
Form (or on the Internal Grant Approval form).
- What do I need to submit, and how many copies?
- Though PATS is an electronic, online system,
signed printouts of all transactions are required.
The specific requirements for each transaction are
- The CCI's regularApplication Submission Requirements apply.
- The CCI's regularAmendment Submission Requirements apply.
Internal Adverse Events:
- Adverse Event
- Copy of Report
to Sponsor, if required
- Adverse Event
- Backup documentation
(e.g. Sponsor's Report)
Progress Reports (Submit
Original and 3 Copies):
- Signed Progress
- Conflict of Interest
Disclosure Forms. The PI and each
of the Key Personnel must complete
and sign a separate COI Form. Key
Personnel include staff assigned
to work on the protocol at any of
the following institutions: AECOM,
MMC, JMC, or NCB. (NOTE: On the
Print page for the Progress Report
form, there is a "COI" button which
will produce a COI form for for
the PI and each Key Personnel required
to sign one.
- Full Review Protocols:
Copy of the Summary,
Risks, and Benefits.
Adverse Event documentation.
Summary of all
since the study
was first approved
by the CCI.
If an internal DSMC
has been established,
attach all DSMC
- If an HHC facility
is included, attach an updated
HHC-641 with current budget
and original signatures if the source
or level of funding has been modified.
- For protocols
that are being performed in collaboration
with other sites/institutions/ individuals/laboratories,
approval by the respective IRB is
required. For this purpose, collaboration
is defined as the (a) transfer of
specimens to or from another institution;
(b) inclusion of patients from another
institution; or (c) transfer/subcontract
of sponsor funds. In these cases,
a copy of the current collaborating
institutional IRB approval of this
study must be included.
- My protocol was converted to PATS (or the protocol
was initially submitted using PATS), and now I need
to submit a transaction (e.g. Adverse Event, Amendment,
Progress Report, etc.). Can I send in the MS-Word
form from the CCI website?
- No. Once a protocol is in PATS, all
transactions must be submitted electronically using
- What are the deadlines for PATS submissions?
- Full Review applications and amendments must
be submitted by out deadlines, as outlined
here. Exempt and Expedited applications may
be submitted at any time. Progress reports are due
by the due date specified in the Email Progress
- I filled out an AE, but it doesn't show up in
the list to submit/print/edit.&nbp; Where did it
- This problem generally shows up on older computers.
The only solution we have is to complete the AE
in a single session. While still on the AE Form
screen, complete the following steps:
- Save the AE. (Reminder:
Do NOT leave the AE Form page.)
- Run the error check
and fix any errors you may have.
- Click the "Submit"
button on the AE Form screen. This
will re-run the error check and,
assuming you are error free, allow
you to click the final "Submit"
button to transfer the AE to us
- Return to the AE
Form (by clicking the Return button
on the Submission screen).
- Click the "Print"
button to bring up the print-view
of the AE. You should find the current
date next to the "Date Submitted"
text near the top of the page.
- Have the PI or
other qualified individual sign
the AE and send it to us.
- I want to apply for a grant (on a new protocol)
... what do I do?
- Follow our current procedure (which can be found
here). In addition to the Grant Accounting face
page, you must bring a completed
CCI Grant Application Form to the CCI, and the
grant will be signed "pending." A CCI # will be
assigned. When the grant receives a "fundable score,"
an application (with the complete grant) must be
submitted to the CCI for review. Use the
application that was started by the CCI when you
originally brought in your grant. (In PATS,
for full/expedited review studies, go to "Applications
| New/Edit Protocol," select the Investigator name
and application type, click on "Edit Application,"
select the CCI # from the list on the right side
of the screen, then click the "Continue" button
at the bottom of the page.)
- How do I submit a protocol, advertisement, etc.?
- At this time PATS does not have an attachment
feature, so all application components (except Informed
Consent Documents and HIPAA forms) must be submitted
on paper. For details, see the
- What is the procedure for submitting PRC studies?
- Complete the CCI application using PATS. After
completing the application, ensure that your application
passes the Error Check, but do not
submit electronically. Instead, use the PATS "Print"
feature to print the application and submit it to
the PRC. If the PRC requires changes, make them
in PATS, then resubmit to the PRC. Once the PRC
approves your protocol, electronically submit the
application to the CCI.
- Help! I started filling out one type of application
(e.g. Chart Review), but now I realized I need a
different type of application (e.g. Behavioral).
How do I change the type?
- The CCI has the ability to change your application
type for you. This feature is only available
before approval. If you
encounter this problem, contact the CCI immediately.
- I completed my application, but when I run the
error check, it says "Informed Consent Documentation,
Alteration or Waiver - When informed consent will
be obtained, the protocol application can NOT be
submitted until the ICD's are entered into PATS.
To do so, return to the 'Applications' menu and
click on the 'Assent/Consent Form' button."
What does this mean?
- This error message means that you have indicated
in your application that you are obtaining Informed
Consent. PATS produces this error when no ICDs have
been included in the application. If you are completing
a new applicaion, add the ICDs. If you have your
ICD(s) in MS-Word (e.g. if you're converting or
if you have a sponsor's ICD) click
NOTE: If you are obtaining Oral Informed Consent,
you must include the script that you plan to use
for obtaining consent.
- How does conversion work?
- There are several steps to conversion. On an
approximately quarterly basis, the CCI selects investigators
to be converted. As the conversion is prepared,
the investigators are notified that they will be
a part of the upcoming conversion and must signup
for training. (Anyone who works on any CCI transactions
for an investigator must be trained.)
The basic information in the applications (e.g.
CCI #, title, funding sources, protocol sites, Internal
Adverse Events, etc.) are converted through an automatic
process. However, a lot of information cannot be
automatically converted, and the responsibility
for both auditing the automatically converted data
as well as populating the missing fields rests with
- Where are my converted protocols?
- After logging in, expand the "Applications"
menu category (click on the plus [ ] sign) in the
System Menu, then click on "New/Edit Protocol."
In the main window, select the investigator's name
from the "Investigator" drop-down menu, then select
the type of Application. Next, click on the "Edit
Application" button and a list of your protocols
will appear in the "Application Selection" menu.
Click on the CCI Number, then click the "Continue"
button, located at the bottom left of the screen.
- How do I get my Informed Consent Documents into
- Follow the instructions for
Converting ICDS from MS-Word to PATS.
Consent Documents (ICDs)
- Every time I try to access the ICD Editor, I
either get errors or nothing loads at all. What
am I doing wrong?
- The most likely cause of this problem is the
use of a browser other than Internet Explorer 6.0+.
If you believe that this is not the problem,
you are using Internet Explorer 6.0+, then contact
- How can I email my ICDs to other people/sites/etc.?
- Currently, there is no built-in feature to email
ICDs, however you can copy the entire text of the
ICD. To do so, click the "Print Preview" icon, highlight
the entire document (Ctrl-A), copy the document
(Ctrl-C), then switch to another document editor
(e.g. MS-Word) to paste into (Ctrl-V).
IMPORTANT NOTE: If you paste into
MS-Word, the HTML code that allows the help text
to disappear during printing will be changed. If
you paste blue text (help text) from MS-Word to
the ICD Editor, the text will appear blue, but will
NOT disappear during printing.
DO NOT PASTE TEXT COPIED FROM MS-WORD
INTO THE PATS ICD EDITOR.
- How do I add a Spanish Consent?
- Step 1: Start an Amendment
in PATS, and enter the Spanish ICD. If it exists
in MS-Word, you can paste the text into the ICD
Editor, however you must follow the instructions
for Converting ICDS from MS-Word to PATS. Submit the PATS Amendment.
Step 2a: If you had your English
ICD translated by a translating service, print out
the PATS Amendment and mail it with a copy of the
PATS SpanishICD as well as the official translated
Step 2b: If you are using the "back
translation" method, print out the PATS Amendment
and mail it with a copy of the PATS Spanish ICD
as well as the back translation, names and credentials
of the translators. NOTE: Do NOT
input the "back translation" into PATS.
- How do I insert special characters into my document?
- You may copy special characters from
Progress Reports (PRs)
- I used to be able to include certain changes
to my application (e.g. adding or removing Key Personnel)
in my Progress Report. How do I do that now?
- Any and all changes to the Application/Protocol
must be done through an Amendment.
- Last year's PR would be so helpful in completing
this year's. Where can I get a copy of it?
- If last year's PR was completed in PATS, you
can use PATS to access it. Go to the PR section
of PATS, then access your past PRs through the "Print
Progress Report" button. If more than one of your
CCI number appear (e.g. 2006-123-001 and 2006-123-002),
choose the latest one (e.g. 2006-123-002). The lower
numbered ones would be PRs from prior years.
- How do I add KP to my approved protocol?
- Start an amendment.
(If you have already started an
amendment, access it, then continue
- On the "New/Edit
Amendments" screen, add the addition
of Key Personnel to the "Amendment
Justification/Explanation & Protocol
- Click on the "Application
- In the application,
scroll down to the orange "Key Personnel"
- On the KP page,
make sure you are in "Add" mode
(i.e. that the "Add" button is lit
- Select the name
of the KP in the "Name" pull down
menu. (NOTE: If the individual you
wish to add is not listed, click
the link to request an addition
to the master list of KP. Wait for
an email back indicating that the
individual has been added. This
may take up to 1 business day.)
- Verify the entries
for the individual's Payroll, YU
School, and Department are correct.
- Enter the KP's
"Role in Study"
- Verify that the
Individual completed the Training
- Click on the "Save"
Still have questions? Ask