Suggested format for SOPs
This format aims to simplify the creation and understanding of Standard Operating Procedures (SOPs) in clinical trials, promoting clarity, uniformity, and traceability in processes. Additionally, it ensures compliance with Good Clinical Practices (GCP) and provides a practical and comprehensive approach to standard documentation.
Description: The title should be brief and accurately describe the SOP’s content.
Example: SOP for Source Data Collection or SOP for Managing Informed Consent.
Description: Briefly explain the objective of the SOP, highlighting its importance within the clinical trial.
Example: To establish guidelines for the accurate collection of source data in compliance with Good Clinical Practices (GCP) to ensure trial integrity.
Description: Identify to whom and what the SOP applies, including specific roles and areas of the clinical trial.
Example:
- Applicable to all investigators and personnel responsible for source data collection at participating study sites.
- Covers activities from initial data collection to final verification.
Description: Describe step-by-step how to perform the activities regulated by the SOP. Use simple language and number the steps.
Example:
- Identify and prepare the required source records.
- Verify that each source record includes complete and consistent data.
- Document each entry in the Case Report Form (CRF) in real-time.
- Review the data and resolve discrepancies following the study protocol.
Description: Detail who is responsible for performing each task mentioned in the procedures, specifying roles or job titles.
Example:
- Principal Investigator: Supervise data collection and verification.
- Clinical Trial Coordinator: Ensure that data are recorded according to the SOP.
- Clinical Monitor: Verify the accuracy of the data and their consistency with source documents.
Description: Include links or references to guides, international standards, or relevant examples that support the SOP.
Example:
- ICH-GCP E6(R2) Guidelines.
- FDA Guidance for Industry: Electronic Source Data in Clinical Investigations.
- Link to examples of SOPs on international organization websites.
Description: Add a record to the document to describe who created, reviewed, and approved the SOP, along with the corresponding dates.
Suggested Format:
- Created by: Name / Role / DD/MM/YYYY
- Reviewed by: Name / Role / DD/MM/YYYY
- Approved by: Name / Role / DD/MM/YYYY
Description: Indicate that the SOP was tested before implementation and specify the effective date.
Example:
- Validated on: DD/MM/YYYY
- Implementation Date: DD/MM/YYYY
In the following document developed by Paula Andrea Marioli, ISN-ACT Committee member and nephrologist at Renálida, you will find an example of Standard Operating Procedures (SOPs) that can be used for your next clinical trial.