FDA, etik kurullar, sponsorlar ve Klinik araştırmacılar için Klinik Araştırma onayı sonrası çalışma denetlenmesi için taslak bir rehber yayımladı.
REHBERİ İNDİRMEK İÇİN TIKLAYIN…
Guidance for IRBs, Clinical Investigators,
and Sponsors
IRB Continuing Review after Clinical Investigation Approval
This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.
TABLE OF CONTENTS
I. INTRODUCTION……………………………………………………………………………………………….1
II. BACKGROUND…………………………………………………………………………………………………2
III. DISCUSSION……………………………………………………………………………………………………..2
A. Criteria for Approving Research During Continuing Review……………………………………………..4
B. Process for Conducting Continuing Review……………………………………………………………………….4
C. Key Topics to Consider During Continuing Review……………………………………………………………8
1. Risk Assessment…………………………………………………………………………………………………………….8
2. Adequacy of Informed Consent……………………………………………………………………………………….8
3. Local Issues…………………………………………………………………………………………………………………..9
4. Trial Progress………………………………………………………………………………………………………………10
D. When Expedited Review Procedures May Be Used for Continuing Review……………………….11
1. Expedited Review Category (8)……………………………………………………………………………………..12
2. Expedited Review Category (9)……………………………………………………………………………………..14
E. Frequency of Continuing Review…………………………………………………………………………………….14
F. Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review……………………………………………………………………………………………………………………………………..15
G. Communicating the IRB’s Continuing Review Determination…………………………………………..18
H. Lapse, Suspension, or Termination of IRB Approval of Research…………………………………….19
1. Lapse of IRB Approval………………………………………………………………………………………………….19
2. Suspension or Termination of IRB Approval………………………………………………………………….21
APPENDIX – CATEGORIES OF RESEARCH THAT MAY BE REVIEWED USING EXPEDITED REVIEW………………………………………………………………………………………………..23 i