When it comes to decentralized clinical trials (DCTs), risk-based monitoring is just as critical as it is for in-person clinical trials.

[Related: Author Jerry Chapman recently presented the webinar, “FDA GCP Inspection Trends Identified Using AI,” which included analysis of FDA enforcement trends involving clinical investigators. The recording of this webinar can be accessed here.]

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At the Society of Quality Assurance 2022 Annual Meeting in Palm Springs, California, FDA Office of Regulatory Affairs Bioresearch Monitoring Division I Director Anne Johnson provided FDA’s perspective on Decentralized Clinical Trials (DCTs) in a presentation titled, “Sponsor Oversight of Decentralized Clinical Trials.”

Part I of this report on Johnson’s presentation at the SQA Annual Meeting covered the background and an overview of the regulations covering clinical trials, and the elements of DCTs, including the design, benefits, and challenges.

Part II included sponsor oversight responsibilities for DCTs regarding electronic informed consent, remote visits, and electronic data considerations.

This third and final part provides the agency’s perspective on risk-based monitoring and FDA guidance that directly impacts DCTs, and Johnson’s advice to sponsors in the form of “points to consider.”

Risk-Based Monitoring for DCTs

A key sponsor oversight responsibility is monitoring—the real-time assurance that the study is progressing as designed and planned. It includes the auditing of hard copy records (if applicable) and electronic records.

The regulations require monitoring the conduct and progress of clinical studies in a particular fashion, they are not specific about how sponsors must conduct it—flexibility in the approach for monitoring is built into the regulation.

Risk-based monitoring is designed by a sponsor and can result in more efficient oversight while still providing critical coverage to assure the protection of the human subjects and ensure data integrity.

[Editor’s note: For more on data integrity and clinical trials, read the article, “Data Integrity and Your Clinical Investigator: What the Data Shows.”]

There are many aspects to focus efforts on the areas that are critical for safety and for study success including prioritizing sites for monitoring based on information available about their performance. To prioritize sites for evaluation, Johnson recommended looking at:

  • The severity and the frequency of study site protocol deviations
  • The population size of randomized subjects that are in a particular trial
  • The experience of the site staff and any known history or prior compliance or audit or inspection findings

Remote monitoring, she said should include paying attention to:

  • Whether key parties are included in the site initiation and training, using a risk-based approach to monitoring. It is helpful to leverage central monitoring if possible, involving the monitors, the data management staff, and the statisticians “to review and analyze data early and often.”
  • Documentation of monitoring or audits, any changes in the audit plans—the who, the what, the when, the why, and the how—and make sure that those procedures are established, that they are documented, and that they are written down.
  • Documentation of communication of the procedures including the timely review of critical data and the timely review of potential compliance concerns and documentation.

Learn about using Redica Systems as an important partner in your risk-based monitoring efforts and how they can help you find and evaluate compliance issues in warning letters and 483s by viewing a recording of the June 2022 Redica webinar, “FDA GCP Inspection Trends Identified Using AI.

Relevant Guidance Documents

Johnson provided the following list of FDA guidance documents that cover the topics she addressed in her presentation:

She also recommended searching the FDA website here for specific topics of interest such as sponsor oversight, remote monitoring, risk-based approaches, electronic informed consent, electronic records and signatures, and digital health technologies.

[Related: Last year, the top 2 most common FDA 483 clinical investigator observations involved: “General Responsibilities of Investigators Conducting Study” and “Investigator Recordkeeping and Record Retention > Case Histories.” Contact us today to learn about how Redica can help you access additional GCP enforcement insights.]

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DCT Points to Consider

Johnson concluded her presentation with some “points to consider” regarding DCTs.

“As a sponsor or even as a site, what are some of the questions that you want to consider when evaluating, participating in, or designing a decentralized clinical trial?”

  • “Does it make sense for this context, for this indication, for this population, for this size? And can we assure that human subject protection is maintained? That is very critical and that is crucial.”
  • “How can we ensure the quality and the integrity of the data? In the design of DCTs it is best to communicate and work closely with the agency and any sites or stakeholders from the very beginning to make sure that the plans that involve the remote aspects and even the integration of mobile technology makes sense for the context in which you wish to use it. Remember that FDA is accessible and open to reviewing and providing early feedback on any exploratory or innovative clinical trial designs.”
  • “Can we ensure robust, reliable data? 21 CFR Part 11 is crucial. It may apply more now than ever, depending on how much electronic interface you use and the degree of digital health technologies that you would use to gather data.”
  •  “With the risk-based monitoring, if it is decentralized, there are multiple locations and a lot of different providers that are participating in the system. How are you making sure that data is accurately captured, maintained, stored, and retrievable in the future?”

Additional Resources

An FDA Perspective on Decentralized Clinical Trials: Part I

An FDA Perspective on Decentralized Clinical Trials: Part II

Data Integrity and Your Clinical Investigator: What the Data Shows

The Components of “Responsibilities of the Investigator” Observations

Extracting Specific Protocol Violations from Warning Letter Citations

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