At Clinical Research Pivot, we offer a specialized regulatory document review service for clinical investigative sites, leveraging the principles of ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) and Good Documentation Practice (GDP). This service ensures that all regulatory documents are compliant with global clinical trial standards, helping sites maintain data integrity, improve audit readiness, and meet regulatory requirements.
Key Features of Our Regulatory Document Review Services:
ALCOA-C Principles:
We apply the ALCOA-C framework to review and ensure the highest level of documentation integrity, focusing on the following:
- Attributable: We ensure that all entries in regulatory documents can be traced back to the individual who created or modified them, with clear sign-offs and timestamps. This applies to all essential documents such as delegation logs, IRB communications, and protocol amendments.
- Legible: We verify that all entries in the documents are clearly legible, especially when reviewing handwritten records or signatures. Any illegible entries are flagged for correction to avoid issues during regulatory inspections.
- Contemporaneous: Our team ensures that documents are completed in real time and that any data entries reflect the timeline of the clinical trial activities. This is crucial in proving that the trial was conducted in compliance with regulatory timelines and processes.
- Original: We confirm that the regulatory documents are original or certified true copies, safeguarding the integrity of trial records. Ensuring that the original documents are retained correctly is critical for regulatory compliance.
- Accurate: All data entries in regulatory documents must be accurate, and our review process includes cross-verifying against source data and other trial documents to identify discrepancies.
- Complete: Our team ensures that all regulatory documents are complete, meaning no sections or information are missing. We check that every document contains all required signatures, dates, and approvals, eliminating gaps that could raise compliance issues during an audit.
Good Documentation Practice (GDP):
In addition to ALCOA-C, we ensure that Good Documentation Practices are followed throughout the document review process, ensuring consistency, accuracy, and audit readiness. This includes:
- Clear Writing Standards: All entries in regulatory documents must follow clear, standard terminology and avoid abbreviations that are not universally recognized. We ensure the site follows GDP by maintaining well-structured and readable documents.
- Cross-Checking of Documents: We review each document to ensure consistency between the various records (e.g., IRB approvals, consent forms, delegation logs). Any discrepancies between documents are identified and corrected, which is vital for regulatory inspections.
- Document Control: Our document review includes verifying that all regulatory documents are under strict version control, ensuring that the latest approved versions are in use and that old versions are archived properly. This is critical for managing protocol amendments, informed consent updates, and other evolving study requirements.
- Corrective and Preventive Actions (CAPA): For any identified deficiencies, we assist in developing and implementing corrective and preventive action plans to address issues and improve documentation quality moving forward.
Examples of Regulatory Documents We Review:
- IRB/EC Approvals: We ensure that all approvals (initial, continuing, and amendments) are up to date, properly documented, and consistent with study activities.
- Informed Consent Forms (ICF): We review ICFs for completeness, accuracy, and compliance with protocol amendments.
- Delegation Logs and Training Records: We verify that all staff are appropriately delegated and trained as per protocol requirements, with proper documentation in place.
- Case Report Forms (CRFs) and Source Documents: We ensure that all data entries match the source documents, and that CRFs are complete and accurate.
- Safety Reporting Documentation: We review all adverse event and serious adverse event reports for timely reporting, accuracy, and completeness.
Why Choose Our Regulatory Document Review Service?
Comprehensive Compliance: By applying the ALCOA-C and GDP principles, we ensure your clinical trial documents meet all regulatory standards and are ready for inspection.
Audit Preparedness: Our reviews ensure that your site is fully prepared for inspections by the FDA, IRB, and other regulatory bodies, reducing the risk of findings or delays.
Expertise and Accuracy: Our experienced auditors and documentation specialists have extensive knowledge of clinical trial regulations, ensuring accurate and compliant documentation across all phases of your trial.
Partnering with Clinical Research Pivot for your regulatory document review needs ensures your clinical site maintains the highest standards of documentation integrity, compliance, and audit readiness.