30/11/2024
Essential documents in clinical research are critical for ensuring the integrity of a clinical trial, compliance with Good Clinical Practice (GCP), and adherence to regulatory requirements. These documents provide evidence of the trial’s conduct, data accuracy, and the protection of participants’ rights. Here’s an overview of essential clinical research documents:
1. Before the Study Starts
• Study Protocol: Detailed plan outlining the study objectives, methodology, statistical considerations, and ethical safeguards.
• Investigator’s Brochure (IB): Summary of clinical and preclinical data about the investigational product.
• Ethics Committee (EC)/Institutional Review Board (IRB) Approvals: Approval letters for the protocol, informed consent, and other study-related documents.
• Informed Consent Form (ICF): Documents used to obtain participants’ informed consent.
• Clinical Trial Agreement (CTA): Contracts between sponsors, investigators, and study sites.
• Financial Disclosure Forms: To ensure transparency and identify potential conflicts of interest.
• Regulatory Approvals: Approvals from national or regional authorities (e.g., FDA, EMA).
• Site Feasibility Assessment: Documentation confirming the site’s suitability for the trial.
• Delegation of Duties Log: Identifies individuals authorized to perform specific tasks in the trial.
2. During the Study
• Case Report Forms (CRFs): Data collection tools for recording participant data.
• Source Documents: Original records of participants’ data (e.g., medical charts, lab results).
• Monitoring Visit Reports: Documentation from sponsor or CRO visits to ensure trial adherence.
• Amendments to Protocols and ICFs: Updated documents following approved changes.
• Drug Accountability Logs: Records of the distribution, storage, and return of investigational products.
• Adverse Event (AE) Reports: Documentation of any AEs or serious adverse events (SAEs).
• Communication Logs: Records of correspondence between study team, sponsors, and regulatory bodies.
• Training Logs: Documentation of team training on protocol and procedures.
3. After the Study Ends
• Final Study Report: Comprehensive summary of study findings and conclusions.
• IRB/EC Closeout Letters: Confirmation of trial completion and closure at the site.
• Audit Reports: Documentation of audits by sponsors or regulatory authorities.
• Clinical Study Data: Finalized and archived data from CRFs and other sources.
• Participant Identification Code List: Maintained securely for future reference (e.g., follow-up).
• Retention Plans: Plans for long-term storage and archiving of trial documents.
Key Standards and Guidelines
• ICH E6 (R2): Good Clinical Practice (GCP) guidelines.
• 21 CFR Part 312 (FDA): Regulations for investigational new drug (IND) studies.
• ISO 14155: Guidelines for medical device.
