There is nothing like an FDA audit, or even a sponsor or CRO audit, to grab our attention regarding the quality of our work.

However, the truth of the matter is we should be prepared and “audit ready” in terms of our sites and our studies at all times. This is a practice I cannot stress enough in regard to building the strength and future of your business. None of our work can be perfect, but with proper process and planning for quality control and quality assurance that is a day-to-day practice within a site’s makeup, we can be audit prepared. 

We might even, over the course of many years conducting research, be the recipient of a 483. If this should occur, it is important we not approach the 483 as a dreaded event but as an opportunity to correct and execute to improve our processes. Certainly, building SOPs around quality is a fundamental need. Whether large or small, an evaluation of how the QA/QC process is carried out at the site is pivotal. 

For example, I recently have employed an individual who is a contractor and past CRA to fulfill the growing need for more structure and commitment to prepping for monitor visits, let alone any auditing process. It actually is an interim action, as we are looking to bring on a full-time staff member to grow this component of our work.

Here are some key points to consider and guide you in reviewing your need for a quality assurance plan.

1.  Definition of 1.46 Quality Assurance (QA) per ICH: All those planned and systematic actions established to ensure the trial is performed and the data are generated, documented (recorded) and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).  

2.  The aim of a good QA: To help the site by preventing “critical findings” during an audit/inspection. Findings can be divided into two broad categories, critical and non-critical. Critical findings affect either the subject’s rights/safety/welfare or data integrity.

3.  The importance of quality: In fiscal year 2013, a total of 46% of clinical investigator inspections warranted some type of action (43% Voluntary Action Indicated and 3% Official Action Indicated). About 34% of the domestic deficiencies observed were protocol related, while 21% were related to records. Another 9% were consent related, with the balance of deficiencies related to drug accountability, adverse events or IRB communication.

4.  Ensuring quality: Sites can achieve quality by ensuring the following steps are taken:

• An internal quality program is in place that ensures clinical trial validity and adherence to GCPs, a site’s SOPs and applicable regulatory requirements
• Have a training program for new employees with operational procedures and policies and provide ongoing refresher training programs
• Ensure the investigator has proper education, training and experience (per ICH 4.1.1)
• Self-auditing: look for gaps in training, identify where the system failed and propose corrective action
• Enforce/uphold and revise SOPs
• Track protocol and process deviations at the site and implement a CAPA program (to prevent occurrence/recurrence)
• Allow external auditors, to validate the procedures and processes that are in place as part of the QA program
• Review source documents and corroborating the transcribed data
• Review monitor reports and follow up until resolution.

Quality is characterized by the ability to effectively and efficiently answer the intended question about the benefits and risks of a medical product (therapeutic or diagnostic) or procedure while ensuring the protection of human subjects.

Quality actually can be debatable and, although we think of it as very quantitative within our frame of reference as clinical researchers, I have found there is indeed a qualitative element that in many cases can be a source of frustration and difference of opinion. What one auditor perceives as an area in need of improvement might not be seen as such by the site. In some cases, this difference of opinion is warranted and can be worked through to find a middle ground solution. If this is not the case, I encourage the team to be open minded about the need to improve quality whenever possible and to take an open-arms approach—as an opportunity and a challenge to improve for the good of the whole. 

We can never be too thorough, and we can always benefit from another’s view on what will bring the most safety and benefit in the long run to the patients we serve. 

Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas.

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