HOW TO PREVENT AUDIT FINDINGS DURING CLINICAL TRIALS?

 HOW TO PREVENT AUDIT FINDINGS DURING CLINICAL TRIALS?

 

INTRODUCTION

In Clinical research, audits are performed  to assess whether the clinical trials were performed in accordance with the protocol, sponsor's standard operating procedures, good clinical practices, & applicable regulatory requirements.1 There are two types of audits: routine audits and for-cause audits. 

COMMON AUDIT FINDINGS IN CLINICAL TRIALS

Some of the common findings in audits of clinical trials are: 

 Informed consent process constitutes a significant portion of audit findings in clinical trials. Some of the common findings include: ICF not dates, the subject not initializing the informed consent, unavailability of source documentation, subject not dating the consent, not being re-consented as and when required or missing of the original consent.

 Incomplete CRFs, disparity in between CRFs and the source documentation, improper correction of errors and

 Another example of audits includes the failure in performing the tests needed to ensure the participant’s eligibility criteria and no proof of PI has analyzing and reviewing eligibility checklist

 No timely grading and signing of Adverse events.

 Not strictly adhering to prototocol in cases such as, No documentation of reasons for missing  tests, changes in appointment leading to missing and poor records storage and changes in protocol without  IRB approval. 

PREVENTING AUDIT FINDINDS IN CLINICAL TRIALS

Informed Consent Process 

The process of Informed consent is heavily dependent on proper communication with the subject. It must the ensured that the essential to have up-to-date version approved by the institutional review board. The form must never be filled out in advance before the start of the study. By noting down the proceedings of how the informed consent was carried out, the subject’s participation in the process, the questions asked and answered and that the subject was provided can also help in preventing any audit findings in the process.

Accuracy of Study Records 

Any disparity in the study records must be avoided. This can be achieved by making sure that the case report forms & the source documents provide complete and requisite information before starting clinical trials and by timely reviewing of the trial information.

Meeting the Eligibility Criteria 

To establish that the subject satisfies the eligibility criteria, it is essential to maintain proper documentation that provides evidence that the subject meets the said criteria. The audit findings in this scenario can be avoided by practicing an exercise wherein, the investigator reviews, signs off the checklist for eligibility and documentation of the cases where the sponsor has waivered the eligibility criteria.

Adverse Event 

Audit findings in case of adverse events can be prevented by immediate evaluation assessments and reporting of the adverse events.

Drug Accountability

To avoid any audit findings in drug accountability, it is important to maintain record documentations of the receipt, consumption, disposition, and return of the investigational drug. 

Adhering to the Protocol

The clinical study must adhere to a realistic protocol at all times. There should be reporting and documentation in case of deviations from the protocol and the appropriateness of such deviations.

Corrective and Preventive Action Plans (CAPA)

Implementing CAPA in clinical trials can be very useful in prevention of audit findings in clinical trials. An effective implementation of CAPA ensures the safety of trial subjects and also data integrity. It investigates the root causes of problems arising and tries to prevent their occurrence or recurrence. It also involves keeping track of trends in compliance of the GCP and issues to recognize the initiatives taken to improve clinical trials. 

CONCLUSION

The best way to prevent audit findings in clinical trials is to first determine the main reasons that lead to these errors. Right from the beginning of the informed consent process to the reporting of adverse events, it must be ensured that the protocol is strictly being adhered to. Another important giveaway is documentation; everything that happens during a clinical trial needs to be properly signed and dated. By implementing and inculcating a practice where the protocol is strictly followed keeping in mind SOPs, GCP guidelines and regulatory requirements these audit findings can be significantly reduced.

REFERENCES

1. Guideline IH. Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 (R2). Current Step. 2015;2:1–60.

2. Available from world wide web URL: [https://www.slideshare.net/jkapoorkapoor71/monitoring-and-auditing-in-clinical-trials]

3. West, Kris Audit Findings in Clinical Trials: Avoiding the Pitfalls Retrieved from: [http://compliance.emory.edu/documents/AuditFindingsinClinicalTrials.pdf ]

4. Available from world wide web URL: [https://florencehc.com/top-5-trial-site-fda-inspection-failures-and-how-to-avoid-them/]

5. Available from world wide web URL: [https://investigate.pfizer.com/sites/default/files/article-images/CAPA%20Management_InvestiGate%20Article_2%20Sep%202014_final%20.pdf.]

  

By-

Pasupuleti Pravallika    (Pharm.D)

Mir Amjad Ali Khan    (M.Pharmacy) 

Student at Clinosol