Department:

UAMS Human Research Advisory Committee

Policy Number:

5.3

Section:

Records

Effective Date:

July 31, 2002

Revision Date:

November 18, 2002

SUBJECT: Protocols Reviewed

Each Protocol (whether full review, expedited review, or exempt) is assigned a unique number by the HRAC Manager.  Numbers are assigned chronologically and each new protocol is maintained in an individual file and then filed numerically.

Records for each protocol include:

1.    Copies of all research protocols reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects [21CFR56.115(a)(1); 38 CFR16.115(a)(1); 45CFR46.115]

2.    Records of continuing review activities [21 45CFR46.115(a)(b)]

3.    Emergency use reports [21CFR56.115(a)(4); 45CFR]

4.    Adverse reactions reports [21CFR56.115(a)(1) and (4); 45CFR] and documentation that the HRAC reviews such reports

5.    Copies of all correspondence between the IRB and the investigators [21CFR56.115(a)(4); 45CFR]

6.    Statements of significant new findings provided to subjects, as required by [21CFR50.25; 21CFR56.115(a)(7); 45CFR]