Introduced in the Fall of 2003, the NIH Clinical Trial Planning Grant Program was developed to provide support for the development of Phase III clinical trials. This program supports the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. 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.

Some of the non-participating ICs may solicit R34 applications using specific Funding Opportunity Announcements (FOAs) in order to meet specific programmatic needs. In some cases those announcements may specify different application characteristics, review criteria, and receipt dates. All such announcements will be published in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/index.html. The FOA for investigator-initiated R34 applications can be found at http://grants.nih.gov/grants/guide/pa-files/PA-06-363.html and articulates the policies and procedures that apply to this program.

Electronic Submission – NIH will require electronic submission of the SF424 (R&R) form through Grants.gov to NIH for all AREA grant applications for the June 1, 2006 application deadline and beyond.

• Registration – 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 .
  
  
• Training resources – video library, archived training sessions and other training resources to learn about the NIH electronic submission process and the new SF424 (R&R) application
  
  
• FAQs – Frequently Asked Questions
  
  
• Tips & Tools - resources to avoid common application submission errors

• 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 the development of other essential elements of a clinical trial as defined by the individual participating ICs.
• lead to the timely submission of an application for support of a full-scale trial, incorporating the elements developed under the R34.

• a project period of one year
• a budget for direct costs of up to four $25,000 modules or $100,000 per year
• include the rationale for the future clinical trial, documenting the significance and need to perform the trial.
• 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

• NIH Institutes and Centers that Do Accept Investigator-Initiated R34 Applications in Response to the Parent R34 Announcement - (PA-06-363): 
  NIA, NIAAA, NIAMS, NICHD, NIDCD, NIDA, NINDS, NEI, ORD, ODS

• NIH Institutes and Centers that DO NOT accept R34 applications in response to this Parent R34 Announcement but ONLY accept Clinical Trial Planning Grant (R34) applications in response to their specific funding opportunity announcements: NCCAM, NIAID, NIBIB, NIDDK, NCI, NIDCR, NIEHS, NIGMS, NHLBI, NHGRI, NIMH, NLM, and NCRR.