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Study ID Number (assigned by Research Office)
Name of Study
Principal Investigator
Name of Reviewer: Primary / Secondary
Date of Review:
Type of review: Full Expedited
Recommendations: / Approved / Clarifications required / Expert opinion required / Resubmission required/ Rejected
Clarifications: / Page No. Item No
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Report:
Signatureofreviewer:
Date:

IRB Study Review-Checklist

Scientific Review
1. / Title clearly stated / Yes No
2. / Signature of PI present / Yes No
3. / Signature of Co-PIs present / Yes No
4. / Signature of O HOD present / Yes No
5. / List of authors mentioned / Yes No
6. / Objectives clearly stated / Yes No
7. / Rationale for study adequate / Yes No
8. / Up to date CVs attached / Yes No
9. / Participant recruitment process described / Yes No NA
-brochures well written / Yes No NA
10. / Inclusion criteria complete / Yes No NA
Exclusion criteria justifiable / Yes No NA
11. / Description of methodology:
a.)Type of study appropriate / Yes No
b.)Sample size formula appropriate / Yes No
c.)Intervention clearly described / Yes No NA
d.)Drug dosage/route/duration clearly stated / Yes No NA
e.)Invasive procedures described / Yes No NA
f.)Study procedures clearly described / Yes No Inadequate (describe)
12. / Plan to withdraw/ withhold standard therapy justified / Yes No NA
13. / Plan for statistical analysis appropriate / Yes No
14. / Safety information on drug / device / vaccine adequate / Yes No NA
15. / Budget included / Yes No
Breakdown of funds justifiable / Yes No
Details of funding agency complete / Yes No
16. / If international study
Details of foreign collaborators adequate / Yes No
HMSC clearance present / Yes No
DCGI clearance present / Yes No
MTA agreement present / Yes No
17. / Statement on COI present / Yes No
18. / CTRI registration present / Yes Will be applied for NA
19. / Agreements to report toIRB stated
- SAEs / Yes No NA
-DSMB details / Yes No NA
-deviations from protocol / Yes No NA
-Yearly progress reports / Yes No
-Publishing findings within 2yrs of study / Yes No

Ethics Review

1. / Full description of process for obtaining consent given / Yes No
2. / Those responsible for taking consent identified / Yes No
3. / Written information about study adequate
-Statement that study involves research / Yes No
-Justification of research / Yes No
-Duration of participant’s involvement / Yes No
-description of all procedures / Yes No
-description of all foreseeable risks / Yes No
-description of any benefits / Yes No
-measures to ensure confidentiality / Yes No
-provisions to drop out of study / Yes No
-participant’s responsibilities towards trial / Yes No
4. / Written and oral information understandable / Yes No
5. / Justification for including vulnerable participants given / Yes No NA
6. / Description of arrangements for obtaining consent present / Yes No
7. / Contact information for queries/ complaints given / Yes No
8. / Compensation / reimbursement plan for participant during study reasonable / Yes No NA
Compensation / reimbursement plan for participant after study reasonable / Yes No NA
9. / Insurance coverage stated, adequate / Yes No NA
10. / Storage and maintenance of data adequately planned / Yes No
11. / All financial arrangements with sponsors clearly described / Yes No NA
12. / Please declare your financial conflict of interest / Yes No NA