VAMHCS RESEARCH SERVICE
COVER SHEET FOR VAMHCS RESEARCH PARTICIPANT DOCUMENT PACKET
NOTE: Research participant documents must be submitted to the VAMHCS Research Service for ALL participants who enroll
in the VAMHCS portions of a VAMHCS research study. Submission of these documents facilitates the following:
• scanning of applicable documents into CPRS,
• auditing of documents by the VAMHCS Office of Research Compliance (ORC),
• auditing of documents by the VAMHCS Privacy Office (PO).
(See
NOTES FOR USE IN COMPLETING THIS FORM
within the table below where you list your documents)
SUPERSCRIPTS
1. At the VAMHCS, a CPRS “flag” is the “Research Subject Clinical Warning” (A “flag” is required by VHA Handbook 1200.05, UNLESS
waived under certain conditions by the IRB).
2. HIPAA authorizations are generally required. Possible reasons why a HIPAA authorization might not be attached:
Re-Consent (Therefore HIPAA authorization has already been obtained at the time of initial consent)
Addendum that does not change HIPAA requirements (Therefore HIPAA authorization has already been obtained at the time of initial consent)
HIPAA authorization was not obtained from the participant (Probable noncompliance)
3. Please state either the participant’s last 4 or birth date, not both (minimum individually identifiable information (III) required for locating the
participant’s CPRS chart)
4. Please use parenthesized categories below to complete the “Consent Type” column for each participant:
1 Consent (10-1086):
(FC)
Surrogate Consent (10-1086):
(SC)
Re-Consent (10-1086):
(RC)
Picture/Voice Consent (10-3203 & 10-5345):
(PVC)
Addendum (10-1086):
(ADD)
Assent (10-1086):
(A)
st
5. If the participant is not a veteran, this may affect items 6 and 7 below.
6. Does a CPRS chart exist: A CPRS chart needs to be created for non-veterans for research purposes if the research involves admission to
VA facilities as in-patients, treatment as outpatients at VA facilities, or use of procedures or interventions in the medical care of the
VAMHCS RESEARCH SERVICE: RESEARCH PARTICIPANT DOCUMENT PACKET
participant at a VA facility or at facilities contracted by the VA to provide services to Veterans A record must be created when the research
requires use of any clinical resources, such as: radiology, cardiology (e.g., electrocardiogram, stress test, etc.), clinical laboratory, and
pharmacy; or if the research intervention may lead to physical or psychological AEs. [VHA HB 1200.05 §43]
7. If a participant is a non-veteran, then there needs to be documentation (VA Form 10-0483) that they have received the VA Notice of Privacy
Practices (NOPP). (Veterans automatically receive the NOPP when they register in CPRS). If the non-veteran has a CPRS chart, then the
10-0483 needs to be included in this packet in order to be uploaded into CPRS. If the non-veteran does not have a CPRS chart, then the
10-0483 needs to be kept in the study research binder and a copy must be included in this packet for auditing by VAMHCS Privacy Office.
Please see Hot Topic Vol 5, No.1a. (NOTE: The requirement to include a copy of the 10-0483 with scanning packets is a slight change from
Hot Topic Vol. 5, No. 1a, in order to facilitate auditing by the VAMHCS Privacy Office).
8. For participants who have an existing CPRS chart, a CPRS consent note MUST be entered (unless waived by the IRB). Please enter the
date of your CPRS consent note (this enables the Research Service to attach the scanned documents to the correct research note in
CPRS). For participants who do not have a CPRS chart and do not need one for the research, please provide a copy of the consent note
(this enables the ORC to perform its consent audit).
PLEASE PERFORM A SELF-CHECK OF THE FOLLOWING CRITERIA BEFORE SUBMITTING THE
DOCUMENTS TO THE RESEARCH SERVICE!!!
The following will be checked by the Research Service prior to being scanned into CPRS. ICFs will be returned by the Research Service
for corrections as necessary:




Copies are good quality (clear and legible)
All pages are present
Headers are complete
A copy of the consent note is attached (required if there is no CPRS chart for the participant)



Footers are present (not cut off by the copying process)
Copies are straight on the page
Copies are paper clipped, NOT stapled
*******************
The following will be checked by the Office of Research Compliance (ORC) in order to conduct its audits of informed consent forms.
ICFs will generally be audited from CPRS-scanned ICFs. In the case of participants who do not have a CPRS chart, hard copies will be
audited by the ORC:




Presence of all required signatures
All signatures are also dated
Dates match with date of consenting process
Consent notes
\COVER SHEET FOR VA INFORMED CONSENT DOCUMENT PACKET.jm091613



Correct version of the ICF was signed
Whether the “Person Obtaining Consent” was
authorized to do so
IRB approval footer is present
VAMHCS RESEARCH SERVICE: RESEARCH PARTICIPANT DOCUMENT PACKET
Cover Sheet for “Research Participant Document Packet”
Date of Delivery to the Research Service: ____________
Page ___ of ____
IRB #: _______________
Protocol Title: _________________________________________________________________________________________________
Principal Investigator: ______________________________
Phone #: ___________
Email: ____________________________
Contact Person: __________________________________
Phone #: ___________
Email: ____________________________
The requirement to “Flag” the participant’s medical record (“Research
Subject Clinical Warning” (RSCW)) has been WAIVED by the IRB (i.e.
RSCW is NOT required for this study) 1.
Yes
No
Number of documents attached:
VA Consents: ____
2
VA HIPPAs : ____
Consent Notes: ____
1
2
3
4
5
6
7
\COVER SHEET FOR VA INFORMED CONSENT DOCUMENT PACKET.jm091613
[Research Service Use Only]
HIPAA
Authorization
attached
Y/N
Date of CPRS
Consent note OR
Copy of the
8
consent note .
NOPP (10-0483) 7.
Y/N
A CPRS chart
exists for this
6
participant .
Y/N
Veteran 5.
Y/N
Consent Type 4.
Participant
Initials & Last 4
3
OR Birth Date .
If no HIPAA is enclosed, why?: ___________________________________
No Problem
(X)
Problem (Specify)
[Research Service Use Only]
HIPAA
Authorization
attached
Y/N
Date of CPRS
Consent note OR
Copy of the
8
consent note .
NOPP (10-0483) 7.
Y/N
A CPRS chart
exists for this
6
participant .
Y/N
Veteran 5.
Y/N
Consent Type 4.
Participant
Initials & Last 4
3
OR Birth Date .
VAMHCS RESEARCH SERVICE: RESEARCH PARTICIPANT DOCUMENT PACKET
No Problem
(X)
8
9
10
11
12
13
14
15
As applicable:
_____________________________________________________
____________________
ORC staff in receipt of documents packet (Initials or signature)
Date
\COVER SHEET FOR VA INFORMED CONSENT DOCUMENT PACKET.jm091613
Problem (Specify)