|
Guidelines
INSTITUTIONAL ETHICS COMMITTEE (IEC)
Clinical trial Protocol and protocol
amendment(s)
The contents of trial protocol should generally include the following
topics
• General Information.
• Name and address of the sponsor of the sponsor and monitor (if other
than monitor)
• Background Information
• Trial Design
• Selection and withdrawal of Subjects
• Treatment of Subjects
• Assessments of Efficiency
• Assessments of Safety
• Statistics
• Direct Access to Source Data/Documents
• Quality Control and Quality Assurance
• Publication Policy
• Supplements
Essential documents for the conduct of a clinical trial
Before the Clinical Phase of the Trial
Documents
• Investigator’s Brochure
• Signed protocol and Amendments, if any
• Information Given to Trial Subjects
• Insurance Statement
• Signed Agreements Between Involved Parties
• Dated/Documented Approval
• IEC Composition
• Approval of Regulatory Authorities, if any
• Curriculum Vitae of Investigator(s)
• Normal Values, Ranges for Laboratory/Technical Procedures and/or Tests
Include in the protocol.
• Medical/Laboratory/Technical Procedures/Tests
• Sample of Labels Attached to Investigational Product Containers
• Instructions for Handling of Investigational Product(S) and
Trial/Study Related Materials
• Certificates of Analysis of Investigational Product(s)
• Decoding procedure for Blind Trials
• Master Randomization List
• Pre- trial Monitoring Report
• Study/Trial Initiation Monitoring Report
During the Clinical Conduct of the Trial
• Investigator’s Brochure Updates
• Any Revisions to protocol of IEC
• Approval of Regulatory Authorities if required
• CV of new Investigators
• Updates of Medical/Laboratory Procedure
• Documentation of Investigational product(s) and Trial Related
Materials Shipment
• Certificates of Analysis of New Batches of Investigational product(s)
• Monitoring Visits Reports
• Relevant Communications other than the site Visits
• Signed Dated and Completed Report Forms
• Source Documents
• Signed Dated and Completed Report Forms(CRF)
• Documentation of RCF Corrections
• Notification by Originating Investigator to Sponsor of Serious Adverse
Events and Related Reports
• Notification by Sponsor to Investigators of Safety Information
• Interim or Annual Reports to the IEC and Regulatory Authorities
• Subject Screening Log
• Subject Identification Code List
• Subject Enrolment Log
• Investigational Product(s) Accountability at the Site
• Signature Sheet
• Record of Retained Body Fluids, Tissue Samples (if any)
After Completion of Termination of the
Trial/Study
• Investigation Product(s) Accountability at the Site
• Documentation of Investigational Product(s) Distribution
• Completed Subjects Identification Code List
• Audit Certificate
• Financial Monitoring Report
• Treatment Allocation and Decoding Documentation
• Final Report by Investigator(s) to the IEC, and Applicable Regulatory
Authorities
• Clinical Study Report
|
