At Clinical Research Pivot, we create version-controlled source document that ensures every assessment and requirement of your clinical trial protocol is captured and accurately reflected in the source documents, including updates from all protocol amendments. This service guarantees that your clinical site stays aligned with evolving protocol amendments, ensures outstanding data quality, ensures study requirements, maintains regulatory compliance, and is always audit-ready.
Key Features of Our Version-Controlled Source Document Creation Services:
- Protocol Adherence: Our team develops custom source documents tailored to your study protocol. As protocol amendments occur, we systematically update the source documents to capture every new requirement, ensuring that your clinical site adheres to the latest version of the study protocol at all times.
- Seamless Amendment Integration: When protocol amendments are introduced, we ensure that all relevant source documents—such as patient visit logs, source data worksheets, and applicable study-specific logs—are updated to reflect the changes. Each amendment is thoroughly reviewed, and the corresponding updates are made swiftly, ensuring no delays or gaps in compliance.
- Robust Version Control System: Our version control system tracks and manages every change to the source documents, creating a clear audit trail. Each document is archived with detailed version history, including timestamps, change summaries, and author identification. This ensures transparency, accountability, and regulatory readiness.
- Real-Time Updates and Notifications: As amendments are made to the protocol and reflected in source documents, we notify all relevant site personnel in real-time. The updated documents are distributed promptly to ensure that only the most current versions are in use, reducing the risk of errors and outdated data collection.
- Compliance with Regulatory Standards: All source documents are created and updated in compliance with FDA, IRB, and ICH-GCP guidelines. Our stringent version control process ensures that your clinical site is always using regulatory-compliant documents that meet both global and local requirements, making audits and inspections smoother.
- Customization for Study-Specific Needs: We create and manage study-specific source documents that are tailored to your trial’s needs, ensuring that critical data points—such as inclusion/exclusion criteria, dosing schedules, and safety assessments—are consistently and accurately documented.
Why Choose Our Version-Controlled Source Document Creation Service?**
- Full Protocol Compliance: We ensure that all source documents are consistently aligned with the most current version of the study protocol, including every amendment, so your site remains compliant throughout the trial.
- Real-Time Document Control: Our proactive version control system ensures that all personnel are using the latest, approved documents at all times, minimizing the risk of using outdated versions and ensuring smooth site operations.
- Regulatory and Audit Preparedness: With our version control and audit trail capabilities, your site will be fully prepared for regulatory inspections, with documentation that reflects all protocol changes and amendments.
By leveraging our version-controlled source document creation service, your clinical site can ensure that every protocol requirement is meticulously captured, while maintaining compliance with evolving regulations and preparing for seamless regulatory audits and FDA inspections.