VA HEALTH CARE SYSTEM PRINCIPAL INVESTIGATOR GUIDE

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

Section\Page

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

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