How to prepare mHealth computerized systems for FDA Regulated Clinical Trials
Technology can offer new and exciting options. The mHealth Research Core (mHRC) has put together this online Navigation Tool to help you balance regulatory considerations while moving your FDA 21 CFR Part 11 (“Part 11”) regulated mHealth research project forward.
Compliance to Part 11
Part 11 is relevant to drug (IND) and device (IDE) studies using electronic data capture and electronic signature (eSignature), when data (e.g., annual reports and/or data sets) are being submitted to the FDA. Please note, Part 11 is NOT applicable to drug (IND) and device (IDE) studies relying on paper data capture.
Compliance to Part 11 is applied using a risk-based approach considering (1) the level of inherent risk associated with the patient population, (2) the level of risk associated with the drug/device used in the study, (3) the intended use of the technology, and (4) whether the study is conducted with commercial intent (i.e., to earn a new indication for a drug or device or to take a new drug or device to market) or without commercial intent (i.e., purely academic and to provide data for clinical reference).
When establishing Part 11 compliance there are three levels of consideration:
- The system/product level
- The configuration level
- The use case level (which is often the study level)
At the use case (study) level, Part 11 compliance often takes the shape of establishing policies and/or procedures to (1) ensure members of your study team performing regulated duties are qualified to perform these duties and (2) to govern your testing and change management procedures for the technology used in the study (e.g., electronic data capture [EDC], electronic consent [eConsent]). To find out more information please check out the Trial-CARE’s Introduction to Part 11 (a PDF presentation). In addition, Trial-CARE has created guidance documents for Investigator Responsibilities in Part 11 Regulated Research and eSignature Requirements in Part 11 Regulated Research.
If your study is regulated by Part 11 or if you would like help determining if your study is regulated by Part 11, please contact the Trial-CARE Division of The Center for Clinical Studies at TrialCare@wustl.edu to set-up a consultation.
General Resources:
- For more information about digital solutions that can be used in research regulated by Part 11, please visit the WashU OVCR Part 11 Information Hub
- Central elements for computerized systems in FDA 21 CFR Part 11 and ICH E6 R3 regulated research:
- Risk Mitigation, User Access Controls, Data integrity (ALCOA Plus)
- Secure and encrypted data collection, transfer, storage, maintenance, and analysis
- Audit trails
Additional Relevant FDA Resources:
- FDA Guidance for Industry Electronic Systems, Records and Signatures Used in Clinical Investigations
- FDA Guidance for Industry Electronic Source Data in Clinical Investigations
- FDA Guidance for Industry Conducting Trials with Decentralized Clinical Elements
- FDA Guidance for Industry Digital Health Technologies for Remote Data Acquisitions in Clinical Investigations
- FDA Guidance for Industry for Medical Mobile Apps
- FDA Device Software Functions
- Software as a Medical Device
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
For more information:
Please contact the mHRC by completing a consult request form. The mHRC will schedule a time for your to meet with the mHRC and Trial-CARE to discuss your study.