Regulatory Updates for Clinical Research Professionals - RECERTIFICATION

Updated December 2024

This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education unit to those who complete the review and correctly answer eight of nine questions.  The module is offered at no cost as a public service. The readers should complete the module at their own pace – there is no time limit.

Once the questions have been answered "off-line" please proceed to the online module to complete this process and to print your certificate of completion. You may download the PDF here.

When you are prepared to access the online module, please go to https://socra.elevate.commpartners.com, to enter your contact information and to complete the online module, and to receive your certificate of completion.

 We suggest you print and review the following documents and answer all questions "off-line."  Once the questions have been answered "off-line," please proceed to the online module to complete this process and to print your certificate of completion.  This module offers 1.0 (one) SOCRA continuing education unit. Refer to the following resources to answer the questions below. 

This recertification module focuses on recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.

It is based on the FDA Guidance. Please review and answer the questions below:

US FDA Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Regulatory Updates for Clinical Research Professionals Learning Module v.19

1. A digital health technology (DHT) is a system that uses all of the following for health care and related uses EXCEPT:

1. Computing platforms
2. WebMD database
3. Connectivity
4. Software

2. Digital health technologies (DHTs) provide opportunities to record data from trial participants whenever the participants may be at home, at school, at work, or outdoors, for which of following?

1. Biomarkers
2. Performance of activities of daily living
3. Sleep
4. All of the above

 3. True or False: A submission and approval of an IDE to the FDA is required for a clinical investigation involving a DHT that meets the definition of a device under Section 201(h) of the Food, Drug and Cosmetic Act and that is categorized as an exempt investigation under 21 CFR 812.2(c).

1. True
2. False

4. Which of the following is a specific issue that should be considered when selecting a digital health technology (DHT) for a clinical investigation?

1. Technical and Performance Specifications
2. Design and Length of the clinical investigation
3. IRB/IEC Review
4. Cost of the DHT

5. Which of the following should consider any risks to trial participants associated with the use of digital health technologies (DHT’s) for data collection?

1. Biostatisticians
2. Sponsor, Investigator
3. IRB/IEC
4. b and c
5. All of the above

6. What are some of the clinical risks that should be considered in the use of a digital health technology (DHT)?

1. Erroneous measurements resulting in inadequate or inappropriate treatment
2. Cybersecurity threats
3. Monitor’s qualifications
4. a and b
5. All of the above

7. Which of the following are clinical risks that should be considered in the use of a digital health technology (DHT) and should be included in the informed consent process?

1. Identification of membership of the IRB/IEC
2. DHTs may be covered by end-user license agreements that may allow DHT manufacturers and other parties to gain access to personal information
3. A statement that the DHT meets the definition of a medical device under Section 201(h) of the Food, Drug and Cosmetic Act
4. Listing of additional clinical sites that are using the DHT

8. Sponsors, investigators and IRB/IEC’s should be aware that unique privacy risks may arise when DHTs are used in Clinical investigations. Which of the following should be considered?

1. Safeguards are in place to prevent access by malicious parties
2. Cost of ensuring cybersecurity
3. Compatibility of hardware platforms
4. Frequency of backup of data

9. To help ensure the quality and integrity of data, adequate protection of participants, and satisfaction of regulatory requirements applicable to clinical investigations, sponsors should consider which of the following for investigations that involve use of DHTs?

1. The budget to include the cost of the DHT tool
2. A risk management plan to address potential problems participants may experience when using the DHT
3. Reviewing IRB/IEC membership and frequency of review
4. All of the above

10. To help ensure the quality and integrity of data, adequate protection of participants and satisfaction of regulatory requirements applicable to clinical investigations, investigators should consider which of the following for investigations that involve the use of DHTs?

1. Ensuring trial participants understand how the information will be used
2. Development of the clinical investigation’s budget
3. Reporting of adverse effects from DHTs to the FDA
4. All of the above

Bonus Question

Source:  https://www.archives.gov/federal-register/the-federal-register/about.html

11. The Federal Register provides a means for the government to announce to the public changes to which of the following?

1. Regulatory meeting outcomes
2. Proposed Rules and Notices of interest to the public
3. Medical Device Clearances
4. Federal Government Budget Information

Once you are prepared to complete the module, please go here, to log in with your email and member ID to complete the module and to receive your certificate of completion.