Select Series: Helpful Information from BRANY’s Quality Assurance Team Are You Audit Ready?
Ensuring readiness for a successful clinical research audit involves meticulous preparation and attention to detail across several key areas. Quality Assurance (QA) reviews serve as checkpoints to assess these areas and identify significant recurring issues that provide sites with the opportunity of rectification for future success. Commonly flagged issues highlighted in these reviews often pertain to:
- Delegation and Principal Investigator (PI) oversight
- Informed Consent Process
- ALCOA and GCP
At BRANY, our QA services play a crucial role in ensuring that clinical research sites are fully prepared for audits, identifying critical areas where improvements are often needed. The following serves as guidance regarding commonly flagged areas where our auditors find significant issues during quality assurance reviews.
By addressing these potential pitfalls and providing educational resources, BRANY QA services help research sites enhance their compliance, data accuracy, and overall readiness for audits, ultimately contributing to the advancement of clinical research and enhancing the likelihood of the site’s continued success.
Delegation and PI Oversight
PI oversight in a clinical trial is crucial for ensuring the study’s integrity, compliance, and the safety of participants. Key aspects include:
- PI has ultimate accountability for the study’s conduct.
- Maintains thorough knowledge of study protocol.
- Ensures all team members are adequately trained and informed of protocol changes, adhering to regulatory requirements.
- Confirms accurate and timely documentation of all trial-related activities, responding promptly to any issues or deviations that arise.
Delegation of authority (DOA) logs are an essential tool in clinical trials for tracking the delegation of tasks and responsibilities from the PI to other study team members. Key aspects include:
- Ensure delegation of tasks are documented clearly with start and end dates, including IRB approval of the study personnel, and all study personnel have appropriate qualifications prior to study start.
- Periodic review of delegated tasks to ensure compliance with clarification for any gaps in training or personnel coverage.
- Proper maintenance of delegation logs helps in maintaining accountability and ensures that the trial is conducted according to the protocol and regulatory requirements.
Documentation of the Informed Consent Process
The informed consent process in a clinical trial is a crucial ethical and legal requirement designed to protect participants. Key aspects include:
- Must be signed by the participant or appropriate representative prior to completing any study specific tasks.
- Only study personnel qualified and delegated are to obtain informed consent from participants.
- Provide potential participants with comprehensive information about the study.
The entire process should be documented meticulously to uphold the integrity of the study and the rights of the participants as well as ensure participants are fully aware of what study participation will require. Aspects of informed consent to document include:
- Detailed documentation of the informed consent process, including date and time; documentation of a certified interpreter when applicable.
- Record of any questions asked by participants and the responses given.
- Verification of participant’s comprehension and voluntary agreement.
- Confirmation that the elements of consent were captured during the informed consent process.
ALCOA – Attributable, Legible, Contemporaneous, Original, Accurate
The ALCOA principles are fundamental to Good Clinical Practice (GCP) and ensure the reliability and integrity of data collected in clinical trials. Data must be:
- A: Attributable – Data should be traceable to a specific individual or source.
- L: Legible – Data must be clear and readable.
- C: Contemporaneous – Data should be recorded at the time of the activity.
- O: Original – Data must be the first recorded instance.
- A: Accurate – Data should be correct and truthful.
This rigor is crucial for maintaining the credibility of the clinical trial results, ensuring regulatory compliance, and ultimately protecting patient safety. By following ALCOA, researchers can provide transparent and verifiable data, which is essential for the approval of new therapies and medications.
BRANY’s QA Services and Offerings
BRANY (Biomedical Research Alliance of New York) provides robust Quality Assurance (QA) services to support clinical research compliance and excellence.
BRANY’s Quality Assurance (QA) offerings are designed to ensure that research institutions maintain the highest standards of compliance and ethical conduct. Prominent among these services is our GCP (Good Clinical Practice) Compliance Auditing, which meticulously evaluates research practices to ensure they meet stringent regulatory guidelines and industry standards.
Additionally, BRANY provides a wealth of educational resources aimed at enhancing research proficiency and integrity. These resources cover critical areas such as Informed Consent, Delegation of Responsibility, and Best Practices, empowering researchers with the knowledge and tools necessary to conduct studies responsibly and effectively.
Want to learn more about the quality assurance function of auditing and how to ensure your site is performing at optimal compliance?
Please email your questions to QA@BRANY.com or visit our website at https://www.brany.com/research-auditing-and-monitoring/ for more information.
