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

Helping over 2000+ learners from all skill levels

Our students have grown their skills by taking our courses. Here are just a few of their stories.

You incorporate high level strategy and critical detail and what I call the “Jewish mother stuff”, noodging your Co-I’s to get their letters done and returned, noodging them again when they send them unsigned or they just aren’t perfect, even down to celebrating the submission with champagne because getting a great proposal out the door IS an accomplishment regardless of whether it is ultimately funded. Just wanted you to know I am loving this series!

Barry Braun, Ph.D., Executive Director, Human Performance Clinical Research Laboratory

Colorado State University

I found what was sent to me very helpful and actually anxiety relieving.

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R01 Grantee, Top 10-Ranked Pediatric Hospital

Thanks for an excellent program! Links to associated webinars [courses] at relevant points in checklists were very helpful.

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Course Details

Who:  While the 10-week workplan leads to the three R01 A0 deadlines, grantees actively writing most major R- or K-level submission or resubmission formats will learn much from the weekly lessons.

What:  10 weekly lessons leading to three sets of R01 deadlines: February 5:, June 5; and October 5.

When:  Available on demand. Refer to the Suggested Schedule below.

Cost:  $499

How:  Feel free to customize these dates for your R- or K-series submission or resubmission by counting backward 10 weeks from your internal deadline.

Suggested Schedules



 Suggested Schedule Cycle I Suggested Schedule Cycle II
 Suggested Schedule Cycle III
Week 10 Nov. 27 Mar. 27 Jul. 27
Week 9 Dec. 4 Apr. 3 Aug. 3
Week 8 Dec. 11 Apr. 10 Aug. 10
Week 7 Dec. 18 Apr. 17 Aug. 17
Week 6 Dec. 25 Apr. 24 Aug. 24
Week 5 Jan. 1 May 1 Aug. 31
Week 4 Jan. 8 May 8 Sep. 7
Week 3 Jan. 15 May 15 Sep. 14
Week 2 Jan. 22 May 22 Sep. 21
Week 1 Jan. 29 May 29 Sep. 28

R01 Deadline: February 5 R01 Deadline: June 5 R01 Deadline: October 5

Feel free to customize these dates for your R- or K-series submission or resubmission by counting backward 10 weeks from your internal deadline.

CME Learning Objectives

At the end of this 10 lesson series, participants will be able to:

  1. Identify and employ crucial steps to take to prepare to write an NIH grant application
  2. Acquire key information about effective NIH writing strategies
  3. Apply NIH effective strategies to writing and revising a draft submission
  4. Utilize learned skills to critique peer drafts to hone their own skills
  5. Develop better grantwriting skills that will carry forward on all submissions, whether to NIH or other funding agencies

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 5 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 is updated with every NIH grant cycle. 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.