Course Description

The PHS Human Subjects & Clinical Trial Information Form is crucially important to application success. I will assess the available NIH resources and provide tips and tricks for gray-area situations. A wide array of sample text from recent applications will accompany the step-by-step instructions. I will conclude with an FAQ and a description of the mistakes I most commonly see reviewers identify in the design and writing of these projects. I will help you write a winning application for your human subjects research.

Updated: June 3, 2021

CME Activity Term
Credits: 1.25 AMA PRA Category 1 Credits™
Original Release Date: August 30, 2021
Review Date (s): August 2, 2022
Termination Date: August 30, 2023

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Thank you for the clinical trials presentation you gave… I know [the information] will be a great help as we advise our PIs on their upcoming proposals.

Thank you very much for such an informative presentation.

Course Details

Who: NIH grantees confused about Human Subjects & Clinical Trial projects, and the people who advise them.

When:  Available on demand

Cost: $199

CME Learning Objectives

At the end of this 1 hour 22-minute session, participants will be able to: 

  1. Acquire an understanding of the NIH clinical trial changes, including the form changes, and why they came about 
  2. Apply that knowledge to understand the difference between information that goes in the PHS Human Subjects & Clinical Trial Information Form versus information that goes in the Approach section of the Research Strategy 
  3. Develop a fundable Approach section that aligns with the latest instructions & guidance in order to obtain funding for human subjects research

Disclosure Statement

All individuals in control of the content for an MMS accredited continuing education activity must disclose all financial relationships with ineligible companies. For this activity, individuals in control of content did not disclose any financial relationships with ineligible companies.

Accreditation Statement and AMA Credit Designation statement

Accreditation Statement 

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Massachusetts Medical Society and Meg Bouvier Medical Writing, LLC. The Massachusetts Medical Society is accredited by the ACCME to provide continuing medical education for physicians. 

AMA Credit Designation Statement 

The Massachusetts Medical Society designates this internet enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Content Disclaimer

Course content updated June 3, 2021. Content of this course was updated and re-recorded on this date. The content was accurate at that time. We recommend that you search for changes that may have occurred to the content since the recording date. Note that the course title may have been modified slightly since the recording.