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Navigating Common FDA Inspection Challenges: Empowering Clinical Sites

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FDA inspections are a critical aspect of clinical research, ensuring adherence to GCP standards and safeguarding participant well-being. Our comprehensive guide is designed to empower your clinical site to navigate these inspections successfully, transforming potential challenges into opportunities for enhancement and compliance.

Anticipating and Addressing Frequent Pitfalls

Identifying and addressing common pitfalls is a key step in preparing for an FDA inspection. Frequent issues include inadequate informed consent documentation, non-adherence to protocols, and inaccurate record-keeping. By proactively tackling these issues, your site can demonstrate a strong commitment to regulatory compliance and patient safety. Regular internal audits and pre-inspection checks are effective strategies for mitigating these risks before an inspection occurs.

Empowering Your Team with Knowledge and Resources

The readiness of your team is crucial to the success of an FDA inspection. Providing regular training on GCP guidelines and FDA-specific requirements equips your staff with essential knowledge. Establishing clear, documented protocols for maintaining and documenting compliance is also critical. Investing in continuous education and resources fosters a culture where quality and compliance are paramount.

Engaging in Continuous Improvement

Viewing FDA inspections as opportunities for improvement rather than merely evaluative exercises can significantly change your team’s approach to compliance. Implementing a systematic review process post-inspection allows your team to address any identified deficiencies and continuously refine and enhance operational practices. This ongoing improvement ensures that your site is always prepared for inspections.

Leveraging Expert Guidance

For those looking to deepen their understanding and enhance their inspection readiness, the course “Preparing for FDA GCP Inspections – Best Practices for Clinical Sites” provides comprehensive insights into preparing for and navigating through FDA inspections. This course offers practical, actionable strategies that can be implemented to enhance your site’s preparedness.

Conclusion

Maintaining compliance and readiness for FDA inspections is achievable with the right strategies, continuous improvement, and access to expert guidance. By embracing these practices, your clinical site can approach inspections with confidence and demonstrate a strong commitment to research integrity and participant safety.

For a more detailed exploration of best practices in FDA inspection readiness, consider enrolling in “Preparing for FDA GCP Inspections – Best Practices for Clinical Sites.” This course is designed to provide you with the knowledge and tools needed to excel in the face of regulatory scrutiny.   Visit our website and enroll in the course today. Ensure your clinical site exceeds the standards set by regulatory authorities.

5Cs to Inspection Readiness Success (for Clinical Sites)

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By the 2K Blog /team

Q: When is the best time to start preparing for an inspection?   

    1. After database lock 
    2. After the inspection announcement 
    3. After IND/IDE Submission 

‎A: If you answered C, you are correct. ‎‎ ‎‎ ‎‎Inspection Readiness is an ongoing process that starts at the beginning of the trial. ‎

We all know that inspections can be quite stressful; however, a stressful environment can be minimized with proper preparation and inspection readiness techniques.  This article will discuss the 5C IRS (Inspection Readiness Success) Model as one of the strategies that can be utilized as an inspection readiness technique for clinical research sites.

The 5Cs are: 

  1. Collect Information – In collecting information, it’s important to consider researching from both internal sources (e.g., prior audits, inspections and monitor visit reports) to determine existing gaps in your processes in addition to external sources (e.g., websites of regulatory authorities such as USFDA, EMA, Health Canada, etc.) to review guidance materials, requirements and expectations.

  2. Collaborate with the sponsor – Be proactive in utilizing inspection readiness tools and collaborating with the monitor & sponsor’s inspection team for additional support in preparing for inspections and implementing effective inspection readiness strategies.

  3. ‎Communicate with stakeholders‎‎ – ‎‎Communicate with internal stakeholders (colleagues, PI, monitor) to address gaps in study-related documentation to ensure that they‎‎ ‎‎are present, ‎‎complete‎‎ and accurate.‎‎ ‎‎ ‎‎ I‎‎t’s equally important to ensure that staff are properly prepared to communicate with external stakeholders (e.g., regulatory authorities) and able to interact ‎‎effectively ‎‎with the Inspector/FDA Investigator prior to, during and after the inspection.‎‎ ‎‎ ‎‎ ‎

  4. Correct via CAPA (Corrective and Preventive Action) Plans – Part of having an effective Corrective and Preventive Action plan for each finding is to include all of the elements such as:

    • Root Cause – Why did this happen? Was it a systemic or isolated event? 
    • Correction – What correction was done to immediately resolve this finding?
    • Corrective Action – What will be your corrective action and how will you implement to ensure this finding does not recur?  For example, you may need to create, improve, revise SOPs and checklists/templates and retrain staff on the revised processes.
    • Preventive Action – What are you checks and balances?  Incorporate preventive measures within a timeframe (e.g., 3- 6 months) to ensure similar finding(s) never happens again.

       

  5. Conduct Compliance Checks – Compliance checks involve the evaluation of the implemented processes from your CAPA.   Utilize checklists at frequent intervals to reveal gaps and determine what’s working vs. what’s not.  In addition, review findings from monitoring visits as gauge for compliance checks especially if time and resources are limited at your clinical research site.

Remember, inspection readiness is an ongoing process.  Incorporating an Inspection Readiness strategy, such as the 5C IRS (Inspection Readiness Success) Model, in your daily operations not only creates a culture of compliance, but also allows your site to proactively prepares for and contributes to the success of future inspections.  

Need a checklist for your site? Become a subscriber to download our free Inspection Readiness Checklist!

 

 

Inspection Preparation Concepts for Clinical Research Sites

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The first thought that typically comes to mind when you hear about an upcoming FDA inspection at your site is the logistics– where to meet, document review, and your facility’s condition.  There are however, other factors to keep in mind for both on-site and remote inspections.

This article will briefly cover the basic principles of a GCP inspections and what clinical site staff should expect and keep in mind for future inspections.

FDA Investigators (commonly known as Inspectors) regularly visit clinical research sites to conduct inspections and ensure GCP requirements are being followed.  In fact, according to FDA’s inspection metrics, almost 800 BIMO or Bioresearch Monitoring  inspections are conducted  at clinical research sites every year (with the exception of the pandemic in year 2020).

What to expect

Whether an FDA Investigator conducts an on-site or remote inspection, he/she will need to show his/her credentials and show an FDA-482 prior  to discussing the inspection’s purpose, scope and  number of days according to the size and complexity of the trial(s) being inspected.

In general, the first day of inspection will also require the review of pre-inspection records, site files and subject files.  Interviews will also be conducted with the study personnel, such as the study coordinator(s) and the Principal Investigator to determine compliance to the regulations, protocol/investigational plan and other study-related procedures.

At the end of each day, the inspectors will do a summary of findings, as well as a general verification of their checklist to confirm if inspection criteria were fully covered and all requested documentation received.

The most important aspects that FDA Investigators  focus on are patient safety and data integrity. They will look at patient consents, adverse event/experience reporting, and anything that could potentially jeopardize the patient’s safety. They also ensure data integrity by confirming the absence of data transcription errors  and compliance to  the regulations, protocol and other study requirements according to CPGM (Compliance Program Guidance Manual) for Clinical Sites.

What to keep in mind

  • Plan Accordingly – Keep a checklist available to ensure documents are inspection-ready. site staff are adequately prepared and technology is properly working for provided access and sharing documentation (especially for remote inspections).
  •  Practice Interview Skills –During the interviews, it is important to inform your staff about the Do’s and Don’ts of interviewing including how to answer the questions asked by the inspectors. For example, all site staff should be prepared to discuss topics such as:
    • Training – Safety-related, Protocol, Case Report Form
    • Delegation of study-related tasks/PI Oversight
    • Subject recruitment
    • Informed consent process
    • Source documentation
    • Data entry
    • Investigational product or device handling

Interviewees only need to answer the question directly with no additional information. Moreover, if you don’t know the answer to a certain question, it is acceptable to say that you don’t have access to that information at the time and that you will get back to them with an answer later.

  • Don’t get defensive/ask questions – Be sure that none of your staff are getting defensive with the FDA inspector as this might come back to haunt you.
  • Ask for Clarification – If you need clarification or have questions about the findings reported by the FDA inspector, it is totally acceptable to point them out. However, defensive behavior is never a good idea.

Key Takeaway

Inspections are an important aspect of clinical research trials.  A proactive approach and consistent preparation from clinical site personnel at the start of a trial, results in a successful inspection at the end.

Need an Inspection Preparation checklist for your site?  Feel free to download our free Inspection Preparation Checklist as a preparation tool.

 

 

 

Our Mission and Purpose

The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.

Our History

2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.