If responding to an NIH or PCORI funding opportunity announcement, tailor the application to address all of the specific instructions and review criteria. Investigators should read and reread the funding opportunity to be sure they address all requirements.

When writing the grant application, investigators should simply and clearly explain the pragmatic trial and justify why this design will be best for testing the research hypothesis. The application should clearly describe what elements of the study design are pragmatic (or not) and justify the design choices to balance the important issues of generalizability and rigor of the pragmatic trial. Remember that the goal of the application is to convince the reviewers that the trial is worth doing and feasible. Include a logical plan for how the planning and implementation of the trial will be conducted.

Before submitting the grant application, it is highly recommended that you obtain feedback about the proposed study from partners, including health system partners, statisticians, patients, and other collaborators.

For NIH-Funded Studies

Within a NOFO, there are portions describing the general purpose and type of research that the NOFO will support, instructions for developing the application, and review criteria that will be used to evaluate the application. For NOFOs that use phased award mechanisms (eg, UH2/UH3, UG3/UH3, R61/R33), the activities that will be conducted in each phase should be clearly described. The application should highlight strengths and identify weaknesses and strategies to overcome them.

If the proposed study meets NIH’s definition of a clinical trial, investigators will be required to include the NIH Human Subjects and Clinical Trials Information Form for the application to describe all of the elements of the study design. Investigators can use eRA Commons to submit the application and track the status of the application through review.

For PCORI-Funded Studies

All PCORI studies must adhere to rigorous PCORI Methodology Standards. To respond to an opportunity, applicants are required to submit of a Letter of Intent (LOI) that includes all requirements outlined in the announcement (See the LOI cheat sheet and tips for creating a responsive LOI).

PCORI offers engagement awards to assist in convening patient stakeholders and community partners as a way to prepare for applications, allowing investigators to convene an in-person meeting or have a series of meetings that help shape study design.

PCORI created the Foundational Expectations for Partnerships in Research to help investigators consider how to meaningfully engage with patients and partners. The document outlines the following features of a successful partnership:

• Diversity & Representation
• Early & Ongoing Engagement
• Dedicated Funds for Engagement & Partner Compensation
• Build Capacity to Work as a Team
• Meaningful Inclusion of Partners in Decision Making
• Ongoing Review & Assessment of Engagement

Dos and Don'ts of a Compelling Research Application

Do	Don't
Justify the research	Skip any steps (such as the literature review)
Include pilot data	Use a dense or confusing writing style
Address potential overlaps	Use appendix inappropriately
Reduce complexity	Include untestable aims
Ensure aims are capable of advancing the field	Include non-relevant aims or fishing expeditions
Choose appropriately expert personnel for a multidisciplinary team	Assume that prior collaboration is irrelevant
Link data collection and analysis to aims
Justify the use of multiple sites and sample size

NIH Data Sharing Policy

NIH released the final NIH Policy for Data Management and Sharing with the aim of fostering the management and sharing of scientific data procured from NIH-funded or conducted research. This policy details the requirements of submission of Data Management and Sharing Plans in compliance with NIH Institute, Center, or Office-approved Plans.

The final policy requires the submission of a plan for extramural grants at application. While this allows for the ability to fund data sharing through grants and to include data sharing in the budget, the intention is to promote data sharing as a crucial part of research, rather than a clerical task. Lastly, this policy outlines the balance between data sharing and maintaining the confidentiality of patient data.

PCORI’s Policy for Data Management and Data Sharing state the expectations that applicants for PCORI funding demonstrate a willingness to support open science, including the sharing of data from their PCORI-funded research. A data management and sharing plan is not required at the applications stage, but awardees must submit such a plan as part of the Full Protocol. For awardees depositing into a PCORI-designated data repository, PCORI will cover reasonable costs associated with the effort needed to prepare, deposit, and maintain data in the repository for a period of at least 7 years after acceptance of the Final Research Report.