Clinical Trial Research Ethics Compliance Form
Study Information
Study Title
Principal Investigator
Institution
Contact Email
Ethics Committee Name/ID
Date of Submission
Protocol Review
Brief Protocol Summary
Describe any identified ethical issues
Participant Information
Inclusion/Exclusion Criteria
Describe informed consent process
Confidentiality & Data Protection
Measures for data confidentiality and protection
Risk/Benefit Assessment
Assessment of risks and benefits for participants
Additional Compliance
GCP (Good Clinical Practice) adherence
Local regulatory compliance
IRB approval obtained
Declarations
Declaration by Principal Investigator
Signatures
Principal Investigator Signature
Date