Standard Operating Procedure for Record-Keeping in Clinical Research
Purpose
This SOP establishes the procedures for documentation and record-keeping in clinical trials and clinical studies. The goal is to ensure the maintenance of accurate, complete, and up-to-date records in compliance with regulatory requirements and Good Clinical Practice (GCP) standards.
Scope
This SOP applies to all personnel involved in documentation and record-keeping activities, including principal investigators, clinical research coordinators, data managers, and other study team members.
Responsibilities
- Principal Investigator (PI): Ensures that documentation and record-keeping comply with the study protocol and regulatory requirements.
- Clinical Research Coordinators: Maintain study records and source documentation according to regulatory and institutional standards.
- Data Managers: Manage data-related records and ensure data integrity and accuracy.
Procedure
- Record-Keeping:
- Maintain accurate and complete records of all study activities, including participant recruitment, consent, and data collection.
- Ensure that records are kept in an organized manner and easily accessible for review.
- Maintain source documentation that supports study data and activities.
- Documentation:
- Document all study procedures, events, and observations in case report forms (CRFs) and other study documents.
- Record deviations from the study protocol and report them according to regulatory requirements.
- Document adverse events and safety monitoring activities.
- Ensure that all documentation is signed, dated, and authenticated as required.
- Data Management and Storage:
- Maintain data logs and ensure the security and confidentiality of
study data.
Store electronic records in secure systems with appropriate access controls.
Archive records in compliance with regulatory and institutional requirements.
Quality Control and Assurance:
Record Retention:
- Conduct regular audits and checks to verify the accuracy and completeness of records.
- Correct any errors or discrepancies in records promptly and document the corrections.
- Retain study records according to regulatory requirements and institutional policies.
- Archive records in a secure and accessible location for the required retention period.
Abbreviations Used
- SOP: Standard Operating Procedure
- PI: Principal Investigator
- GCP: Good Clinical Practice
- CRF: Case Report Form
Documents
- Study records (e.g., recruitment, consent, data collection)
- Case report forms (CRFs)
- Source documentation
- Data logs and storage records
- Quality control and assurance reports
References
- Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
- Institutional policies and procedures
SOP Version
Version: 1.0