| 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]