Free audit report template 38Free audit report template 38Free audit report template 38
Download the document to the computer for easy use
There are more pages to preview,Read on

JRMO Audit Checklist and report template
a) Administrative information
Trial Name
Chief Investigator
ReDA Number
Sponsor
IMP name
IMP status
Number of Sites
Number of subjects
Withdraws/dropouts
Final sponsorship Date
First Patient consented
Auditor

b) Background and General information
1. Reason and cause for audit
2. Reference texts
3. Grading of findings
4. List of persons involved in the trial and contacted during audit

i. List of personnel involved in the study
Full Name

Full Name

Role

ii. List of personnel met during the audit (if different)
Job title
Role

c) Personnel, Facilities and Equipment
1. Personnel
2. Training
3. Delegation
4. Principal investigator oversight
5. Equipment
6. IMP
7. Laboratory
Finding Number
Finding description
Grading:
Responsibility:

JRMO Audit Checklist and report template

V1.0

Page 1 of 4

d) Administrative Aspects of the trial
1. Summary of approvals
2. Application /notification to competent Authority
3. Contacts with the research Ethics Co