Data Management and Reporting in FDA-Regulated Clinical Trials

Data management and reporting are essential practices when undertaking FDA-regulated clinical trials of medical devices. Ensuring the accuracy and security of your clinical data, and your compliance with Good Clinical Practice (GCP) will in large part determine the success of your study and your regulatory submission to FDA.

With that in mind, this article will walk you through the FDA’s guidance and regulations on clinical data management and reporting, as well as what you’ll need to consider when using an electronic data capture (EDC) system.

BONUS RESOURCE: Click here to download a free checklist that can support you in keeping track of FDA's requirements on clinical data management and reporting in MedTech clinical studies.

How does GCP affect data management and reporting in FDA-regulated clinical trials?

ISO 14155:2020 is the international standard for Good Clinical Practice during the clinical investigation of medical devices. ISO 14155:2020 is also an FDA-recognized consensus standard, meaning the agency will accept a Declaration of Conformity to the standard.

When it comes to data management and reporting, there are several clauses and subclauses of ISO 14155:2020 that you will need to pay particular attention to, including:

• 7.4 - Adverse event and device deficiencies
• 7.7 - Subject privacy and confidentiality of data
• 7.8 - Document and control data: which includes clauses on traceability of documents and data, proper recording of data, and electronic data systems.
• 9.2.5 - Safety evaluation and reporting
• 10.8 - Safety reporting

For trials in the US, the FDA has issued various guidance documents on GCP and clinical studies, providing detailed information on regulatory expectations and best practices. You can find more information on them here:

• FDA Clinical Trials Guidance Documents
• Center for Drug Evaluation and Research (CDER) GCP
• GCP Educational Materials

What are the key elements of data collection and management for FDA-regulated clinical trials?

The FDA’s regulatory requirements for Good Clinical Practice are spread throughout Chapter 21 of the Code of Federal Regulations. Below, I’ve listed and briefly explained some of the most important requirements that touch on data management and reporting during your study.

Informed consent

In 21 CFR Part 50: Protection of Human Subjects, you can find the FDA’s requirements for informed consent of study subjects. Informed consent is a non-negotiable part of your clinical trial and it must be obtained and documented according to the requirements in Part 50 prior to beginning a clinical study:

“No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.”

One of the simplest ways to obtain and record informed consent according to FDA regulations is to use a compliant eConsent tool that is part of a single electronic data capture (EDC) system, like Greenlight Guru Clinical. By doing so, you’ll have confidence that all your records are securely stored and maintained, and that you’re in compliance with regulations like 21 CFR Part 11.

Electronic data management

21 CFR Part 11: Electronic Records and Electronic Signatures is essential to the conduct of clinical trials, as it established the criteria for creation, modification, and maintenance of electronic records and electronic signatures. If you’re capturing and managing data electronically, it must be stored and validated in a protected system that prevents the loss or damage of records. 

Compliance with Part 11 is critical, because as the regulation states, “This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.”

For instance, I just mentioned that informed consent may be obtained electronically, but that is only possible if the system used to obtain consent is Part 11 compliant. And any clinical data you obtain must also be maintained in a Part 11-compliant system in order to maintain an audit trail that will be accepted by FDA. FDA has also put out a Q&A guidance document on the electronic informed consent to help clarify regulatory requirements and answer questions on the subject. 

Again, the simplest way to ensure Part 11 compliance is to collect, store, and manage all your clinical data in an EDC system that comes with Part 11 compliance built in from the start.

Adverse event (AE) reporting

Requirements for reporting can be found in both 21 CFR Part 56: Institutional Review Boards and 21 CFR Part 812: Investigational Device Exemptions. The FDA’s guidance document on the subject states that:

• For device studies, investigators are required to submit a report of an unanticipated adverse device effect  to the sponsor and the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator first learns of the event.
• Sponsors must immediately conduct an evaluation of an unanticipated adverse device effect and must report the results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days after the sponsor first receives notice of the effect.

ISO 14155:2020 also includes AE reporting requirements in clauses 9.2.5 and 10.8. Prompt and compliant reporting of any adverse event to both the IRB and FDA is important for patient safety during the conduct of a clinical trial and it is not something you can afford to ignore. 

Fortunately, Greenlight Guru Clinical offers an adverse event module for ISO 14155:2020-compliant reporting. The customizable module is fully integrated into the eCRF module and provides automatic notifications to both users and sponsors, along with an AE-specific data export.

Compliant use of electronic data capture (EDC) systems in an FDA-regulated clinical study

Many sponsors now use EDC systems to collect and manage clinical data during a trial due to the difficulties and problems inherent in collecting data on paper or spreadsheets. Using an EDC system built for medical device clinical trials comes with a number of advantages:

• Real-Time Data Entry: EDC systems allow for real-time data entry, reducing delays and enhancing data accuracy. With traditional paper-based data collection, physical CRFs must be completed by researchers, shipped to the study sponsor, and transferred by data entry teams into a computer database before analysis can occur. 
  
  Using an EDC software for clinical data collection bypasses this lengthy process by empowering researchers to create the data in a digital format with an eCRF. 
• Centralized Data Management: These systems provide a centralized platform for managing and monitoring data, improving efficiency and oversight.
  
  Companies that use paper or spreadsheets also run into problems with project management. Clinical trials often happen at multiple sites, and without a firm plan for centralizing your data collection, it can create data fragmentation—especially if the methods for each entry location are different. 
• Reduced Errors: Automated data validation checks within EDC systems help minimize errors and inconsistencies. And by using a single, centralized system for data collection and management, you avoid the high potential for error that occurs when you mix clinical data collection methods. 

A MedTech-specific EDC system, like Greenlight Guru Clinical, will also facilitate compliance with GCP and relevant regulatory requirements like the ones above. For instance, ISO 14155:2020 requires any electronic system be validated “in order to evaluate the authenticity, accuracy, reliability, and consistent intended performance of the data system.”

So, if you’re using an electronic data capture (EDC) system, you will need to comply with procedures outlined in section 7.8.3, which include requirements to:

• Verify and validate that the requirements for the electronic clinical data system can be consistently met
• Ensure attributability, completeness, reliability, consistency, and logic of the data entered
• Ensure that data changes are documented and an audit trail is maintained
• Maintain a security system to prevent unauthorized use of data, both internally and externally.

BONUS RESOURCE: Click here to download a free checklist that can support you in keeping track of FDA's requirements on clinical data management and reporting in MedTech clinical studies.

Greenlight Guru Clinical is built for compliant MedTech clinical trials

With so many regulatory requirements to keep track of during a clinical trial, it only makes sense to use a single, centralized EDC system that proactively helps you stay compliant and eliminates unnecessary regulatory burden during your study.

Greenlight Guru Clinical is the leading clinical data collection toolbox, purposefully built for MedTech. With Greenlight Guru Clinical, you can easily collect and manage clinical data during pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more. Better yet, our EDC system meets FDA regulatory requirements and ensures out-of-the-box compliance with GCP according to ISO 14155:2020 

If you’re ready to learn more, contact us today for your free personalized demo of Greenlight Guru Clinical →.