Materials

Candidates should follow the application guidance and requirements specified in the request for applications, using the documents listed below.

• Face Page: PHS 398 Form Page 1
• NIH Biosketch include a biosketch for the candidate and mentor(s)
• Acknowledgment Letter from IRB/HRPP Template: Required from the Institutional Review Board/Human Research Protection Program (IRB/HRPP) official
• PHS 398 Budget Form Pages 4 and Form 5 with Budget Justification following PHS 398 Instructions 
  
  • 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

Pre-Submission Training Requirements

To ensure foundational understanding of ePCTs, candidates are required to review the following materials before preparing an application. Candidates must attest in their application that they have completed and understood these materials:

• Pragmatic Clinical Trials: How Do I Start? (Video)
• 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.
  • Describes if the intervention is ready for an ePCT
• 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
  • Describes the key design elements in an ePCT