Materials

• PHS 398 Form Page 1: Face Page
• NIH Biosketch (include applicant’s and mentors’ biosketches) (PDF Upload)
• TEMPLATE - Acknowledgment Letter from IRB/HRPP Template
• PHS 398 Budget Form Pages 4 and Form 5 with Budget Justification (PHS 398 Instructions) (combine Budget Forms and Justification into a single PDF Upload)
  
  • PHS 398 Form Page 4: Detailed Budget for Initial Budget Period (Direct Costs Only)
  • PHS 398 Form Page 5: Budget for Entire Proposed Project Period (Direct Costs Only)
  • Budget Justification: Use PHS 398 Continuation Format Page
  • PHS 398: Resources Format Page

Required Readings and Videos

• View the Living Text Book Grand Rounds: Pragmatic Clinical Trials: How Do I Start? Greg Simon & Lesley Curtis
• Read the Readiness Assessment for Pragmatic Trials (RAPT) OR view IMPACT Grand Rounds on the RAPT Model:
  • Readiness Assessment for Pragmatic Trials (RAPT): A model to assess the readiness of an intervention for testing in a pragmatic trial. Rosa Baier, Eric Jutkowitz, Susan Mitchell, Ellen McCreedy & Vince Mor. BMC Med Res Methodol 2019;19(1):156; OR,
  • IMPACT Grand Rounds: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations. Rosa Baier, Eric Jutkowitz & Laura Gitlin.
• Read the PRECIS-2 Tool: Designing trials that are fit for purpose. Kirsty Loudon, Shaun Treweek, Frank Sullivan, Peter Donnan, Kevin Thorpe & Merrick Zwarenstein. BMJ 2015;350:h2147