NeuAge Institute (NAI)

3 Common Audit Deficiencies To Avoid: Lessons from Clinical Research Training

A clinical research coordinator carrying out an audit after clinical research training.

A clinical audit is a systematic review of practices and results to ensure the highest standards are maintained throughout the drug development and clinical research process. In clinical research, an audit is an independent examination of trial-related activities and documents. It’s designed to determine whether the evaluated clinical trials were conducted and whether data thereof was recorded, analyzed, and accurately reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.

Audits are not just a regulatory necessity; they are useful for maintaining the integrity, safety, and credibility of studies. Audit findings can be eye-opening, revealing gaps in practices that can jeopardize a study’s validity. Here, we spotlight three of the most common audit deficiencies encountered in clinical research and share insights on how to circumvent them.

1. Insufficient Documentation

Just as our clinical research courses emphasize, clinical research is as much about the process as it is about the results, and documentation is one of the most vital aspects of this process. Documentation in clinical research provides verifiable records of the study’s journey, capturing every step, decision, and outcome. The primary aim of an audit is to scrutinize these records, ensuring that the study’s processes and results are transparent and reproducible. Detailed records provide proof of the study’s integrity, authenticity, and reproducibility. Yet, inadequate documentation is among the most common audit deficiencies.

Insufficient documentation in clinical research can lead to a cascade of repercussions, ranging from the loss of data credibility to potential risks for study participants. When proper records are not maintained, it becomes challenging to verify the research processes and outcomes, jeopardizing the study’s integrity and functionality. 

Furthermore, inadequate documentation can result in non-compliance with regulatory standards, inviting penalties or even halting the research. Ultimately, the reliability of the study is compromised, diminishing its value in the medical community and possibly impeding advancements in patient care.

A female clinical research professional holding a test tube in a laboratory after clinical research training.
As per our clinical research courses, clinical trials are conducted in a controlled environment.

This deficiency can be avoided by diligently documenting every aspect of the research. This includes the signing and dating of informed consent forms by participants, capturing complete records of study activities, documenting all communications, noting every decision, and detailing any changes made during the research journey. It’s vital to provide justifications for any deviations from the initial study plan. Using standardized forms and digital platforms can aid in uniform documentation, while regular backups ensure data preservation.

2. Protocol and Regulatory Non-compliance

Clinical research is governed by detailed protocols to ensure the safety of participants and the validity of results. These protocols are aligned with wider regulatory standards established by health authorities. Non-compliance with either is not only an audit red flag but can jeopardize the entire study. Despite this, non-compliance with these guidelines is a recurrent audit issue, posing risks to both the study’s credibility and its participants. 

To circumvent this, researchers must immerse themselves in all relevant protocols and regulations before embarking on the study. Regular training sessions can keep the research team updated about protocol intricacies.

A clinical research professional checking collected data after clinical research training.
Incorrect process validation is an audit deficiency to avoid after clinical research training.

Additionally, when changes to the protocol are inevitable, they should be pursued with the necessary approvals and must be comprehensively documented. Keeping abreast of the dynamic regulatory environment, through subscriptions to updates from regulatory bodies or joining clinical research forums, can also be invaluable. An internal mock audit can further prepare teams, highlighting areas of non-compliance in advance of the formal audit.

3. Data Integrity Shortcomings

As clinical research training emphasizes, the collection, analysis, and interpretation of data lies at the heart of clinical research. The integrity of this data, meaning its accuracy, consistency, and reliability, is non-negotiable. Shortcomings in data integrity not only flag during audits but also cast shadows on the research findings’ validity. 

Upholding data integrity requires the establishment of sturdy data collection and storage systems. Using validated software for capturing electronic data can be a significant first step. Every team member must also be made to recognize the importance of accurate data entry, recording, and analysis. 

Consistency in data collection methods, especially when multiple researchers or sites are involved, is crucial. Automated data transfer methods, as opposed to manual transcription, can help minimize errors, ensuring that the data remains pristine throughout its lifecycle.

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