Clinical Trial Ethics Committee Review Form
Study Information
Study Title
Principal Investigator
Institution/Organization
Protocol Number
Date of Submission
Review Type
Initial
Amendment
Continuing Review
Other
Review Checklist
Compliance with ethical principles (Declaration of Helsinki, GCP, etc.)
Adequate and comprehensible informed consent process
Acceptable risk/benefit ratio
Appropriate protection for vulnerable populations
Protection of participant privacy and confidentiality
Proper data collection and management plan
Comments by Reviewer
Summary of Ethical Issues
Required Modifications / Conditions
Other Comments
Committee Decision
Decision
Approved
Approved with modifications
Not approved
Defer
Date of Decision
Committee Chairperson/Reviewer
Signature