The NIH Clinical Trial Planning Grant Program (R34) supports development of Phase III clinical trials. This program supports

• establishment of the research team,
• development of tools for data management and research oversight
• definition of recruitment strategies,
• finalization of the protocol
• preparation of an operations/procedures manual

The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial.

The R34 Parent Funding Opportunity Announcement for investigator-initiated R34 applications can be found at PA-09-186 and articulates the policies and procedures that apply to this program.

This website describes the use of the investigator-initiated R34 and describes the NIH Institutes and Centers (ICs) that intend to accept such applications.

• a project period of one year
• a budget for direct costs of up to four $25,000 modules or $100,000 per year
• include a rationale for a future clinical trial, documenting significance and need.
• describe the potential impact of the clinical trial on health care, policy or practice.
• provide adequate information for reviewers to evaluate how the trial would be conducted
• address the availability and population description of the requisite patient population
• plans for recruitment outreach and follow-up
• address issues and challenges regarding adherence to the proposed intervention protocol

The planning grant is designed to:

• permit early peer review of the rationale for the proposed clinical trial;
• permit assessment of the design/protocol of the proposed trial in its current, early form;
• provide support for the development of a detailed MOP; and
• support development of essential elements of a clinical trial defined by the individual participating ICs.
• lead to an application for support of a full-scale trial, based on elements developed under the R34.

• NIH Institutes and Centers that Do Accept Investigator-Initiated Applications in Response to the Parent R34 Announcement - (PA-09-186):
  NIA, NIAAA, NIAMS, NICHD, NIDA, NEI, ODS

ICs may solicit R34 applications using Institute/Center specific Funding Opportunity Announcements (FOAs) that may have different application characteristics, review criteria, and receipt dates. These announcements are published in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/index.html.

• NIH Institutes and Centers that DO NOT accept investigator initiated applications in response to this Parent R34 Announcement but ONLY accept Institute/Center  specific Funding Opportunity Announcements for Clinical Trial Planning Grant: NCCAM, NCI, NCRR, NHGRI, NHLBI, NIAID, NIBIB, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR, NLM, and FIC.

Electronic Submission – NIH requires electronic submission of the SF424 (R&R) form through Grants.gov to NIH for all R 34 grant applications. The NIH electronic submission process requires institutional registration in two separate systems: Grants.gov and eRA Commons. Project Directors/Principal Investigators also must be registered in eRA Commons. These registration processes can take up to four weeks (possibly longer for new organizations) to complete. All registrations must be in place prior to application submission. For additional information on preparing for electronic submission to NIH please visit: http://era.nih.gov/ElectronicReceipt/preparing.htm.