VA HEALTH CARE PRINCIPAL INVESTIGATOR GUIDE has been updated to comply changes required as part of the University of Iowa Human Research Protection Program Reaccreditation review.  A track change version is also available.

A summary of those changes is also contained below:

Updated Content


Updated phone numbers to include a “63” in front of all VA Extensions.

Throughout VA Guide

Adding disclosure statements to consent based on ICH-GCP (E6) (R2) guidelines

5.B ICH-GCP/p. 24-25,

Section 5.B.i What does this mean? (pg. 122)

Removing expectation to request a waiver of informed consent or waiver of documentation of consent for screening purposes

5.E.ii Screening, recruiting, or determining eligibility prior to a signed informed consent document/p. 30

Adding section on ICH-GCP (E6) (R2) guidelines for non-therapeutic clinical trials

7.M.IX  Non Therapeutic Clinical Trials following full ICH-GCP (E6)(R2) New section/p. 48

Research falling under the FDA using REDCAP are subject to ensuring 21 CFR 11 requirements are met.

12.B.i  Distribution/storage by use of Redcap (pg. 112)

Clarification added to expectations of record retention Specific documents required now identified

9.D.iv.b.ii Recordkeeping and record retention 21 CFR 312.57/p. 72