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  1. Women's Health Events

Bringing Clinical Research to Patients

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FDA’s Office of Women’s Health (OWH) is pleased to present a series of educational webinars on a broad range of topics to promote, protect, and advance the health of women. These webinars target the needs of researchers, health care professionals, and students.

On November 8th, 2023, the Office of Women’s Health hosted a webinar in collaboration with CDER’s Office of Medical Policy, titled: Bringing Clinical Research to Patients. This webinar discussed the new strategies currently available for bringing clinical research to all patients, including women.

About Decentralized Clinical Trials (DCTs)

Decentralized clinical trials (DCT) are trials where some or all the trial-related activities occur at locations other than traditional clinical trial sites. DCTs can apply several strategies to bring the trial to the trial participant, including using video and telemedicine visits, digital health technologies, direct distribution of investigational products to participants, electronic informed consent, home visits, and local health care providers and local health care facilities. 

DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or access to traditional trial sites. These strategies may help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse study participant population. 

Clinical research may also involve the use of real-world evidence (RWE) acquired directly from health care providers or patients themselves. Further, this webinar discussed the mobile app and website CURE ID, which FDA developed to crowdsource clinical information from health care providers and patients, including during pregnancy.

Watch the full webinar recording below.

If you are a physician, nurse, nurse practitioner, pharmacist, or pharmacy technician seeking continuing education (CE) credit, please follow the instructions below to view the recording within the FDA CE Portal, complete the evaluation, and claim CE credit.

Instructions for viewing the webinar recording, completing the evaluation, and claiming CME/CNE/CPE credit:

  1. Navigate to https://ceportal.fda.gov/.
  2. If you have an account, please login.
  3. If you do not have an account, click on “Create an account.”
  4. Once you’re logged in, please complete your profile if you haven't done so already. 
  5. Navigate to the “Web-based Courses” tab.
  6. Select the activity you want to complete.
  7. Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear.
  8. Begin the activity by clicking on the link at the bottom of the page.
  9. After viewing the presentation, click on “Complete Post-test.”
  10. After successful completion of the Post-test, click on “Complete Evaluation.”
  11. After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion.

Requirements for receiving CE credits:

  1. Review the activity, complete the post-test and evaluation. Upon completion of all required steps, physicians, nurses, and nurse practitioners may view/print their statement of credit directly from the CE Portal.
  2. Pharmacists and pharmacy technicians will need to provide their NABP e-profile ID number, as well as their DOB in MMDD format in their CE Portal Profile to claim CE credit. Pharmacists and pharmacy technicians should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.

Initial release date: January 25, 2024

Expiration date: January 24, 2027

 

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