Investigator-Initiated Clinical Trial R34 Planning Grants Questions and Answers

Table of Contents

R34 General Information

An NIAID Clinical Trial Planning Grant (R34) provides principal investigators with funds to prepare 1) materials NIAID needs to determine a project's feasibility and 2) documentation required for applying for an NIAID clinical trial implementation grant (R01), cooperative agreement (U01), or SBIR Phase II award (U44).

Examples of activities supported by the R34 are:

  • Establishing a research team.
  • Identifying collaborators and enrollment sites.
  • Designing the study.
  • Developing milestones.
  • Developing the complete clinical protocol.
  • Developing plans for data and safety monitoring, statistical analysis, data management, and data sharing.
  • Creating the informed consent and assent form, if applicable.
  • Developing the investigator's brochure and manual of operations.
  • Writing a description of recruitment strategies.
  • Developing a plan to acquire and administer study agents.
  • Obtaining Office of Human Research Protections assurances.
  • Preparing agreements and arrangements.
  • Determining whether the trial will be conducted under an IND or IDE and who will hold it.
  • Preparing the package to submit to regulatory authorities.
  • Developing a detailed budget for the clinical trial including preparation of a final study report.
  • Developing training materials and training plans for study staff.
  • Developing and testing procedures for biospecimen collection, storage, and shipping.

It cannot be used to prospectively gather preliminary data to support the rationale for a clinical trial.

No.

No. However, you must have ready all the documentation you would have prepared during an R34 clinical trial planning grant.

Yes. NIAID program staff may be able to provide or direct you to information that can help you prepare your clinical trial documentation.

Most institutions are eligible, whether academic, for-profit, nonprofit, domestic or foreign. Read more in the Section III of the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement.

No. However, you may find the NIAID Clinical Terms of Award helpful for developing the documentation needed for a later R01 or U01 clinical trial application.

Yes, in one of these three situations:

  1. Your research might fit better into our existing clinical trial infrastructure.
  2. Your research is more appropriate for a different funding opportunity: a request for applications, a program announcement, or a solicitation.
  3. Your research might not qualify as a clinical trial under NIH’s Definition of a Clinical Trial.

In any case, you should speak to the NIAID point of contact listed in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement to confirm.

Planning the Application

No. However, we do strongly encourage you to request a prior consultation with NIAID staff. Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

We recommend that you follow these steps:

  1. Prepare for a discussion.
  2. Call or email. 
    • At least 10 weeks before the application due date, call or email the program officer listed in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement to discuss your research idea and get advice.
    • Allow enough time. We strongly recommend that you request prior consultation as soon as possible—it may take six weeks for us to respond after you contact us 
  3. Prepare your request. Within two weeks after your prior consultation do the following:
    • Send all information your program officer requested from you.
    • Allow six weeks for Institute response.

See Requesting Prior Consultation—Clinical Trial Applications and Planning Grants and the questions below for details.

Yes, the limit is five pages.

A program officer will send you a letter signed by the NIAID division director that summarizes the prior consultation, which you will include with your R34 application.

No. The letter of intent is optional. See your notice of funding opportunity for deadlines and instructions.

You may request up to $150,000 in direct costs for up to one year of support.

No, you may submit more than one application provided each is scientifically distinct.

No, each R34 application will support planning for one clinical trial.

Writing the Application

Go to these NIAID resources:

Contact the appropriate NIAID point of contact in the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement for division-specific templates, guidance, and requirements for clinical trials.

Prepare your application using the SF 424 grant application. Read the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement for details.

Attach a copy in the SF424 (R&R) Cover form of the Grant Application.

Your Research Plan is limited to one page for the Specific Aims, 12 pages for the Research Strategy.

The following three sections comprise the Research Strategy: Significance, Innovation, and Approach. Your Research Strategy may not exceed 12 pages and must include:

  • A discussion of the significance of the problem being studied, the need for the trial, and the potential impact of the results of the trial, as well as how the trial will test the hypotheses proposed
  • A concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the trial
  • Sufficient details of the clinical trial (e.g., study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s), preliminary sample size, clinical end points, duration of recruitment and follow-up) to allow  assessment of the likelihood that a feasible clinical trial will be developed
  • A description of the potential problems, alternative strategies, and benchmarks for success of the planning period and future trial
  • A description of how the planning period will be used and descriptions of the activities to be carried out during the planning period, including participants in the planning process and their roles
  • Information about how the clinical trial documents will be developed
  • A description of how the trial will be organized and managed, including the plans to identify and select additional collaborators, if applicable

Although your planning grant will not involve human subjects, your application must describe the availability and attributes of the study population and plans for recruitment, outreach, and follow-up.

Also describe plans to address ethical and safety issues and any challenges you anticipate to adherence to the protocol.

Yes. Your resource sharing plan should address a Data Sharing Plan.

Yes, if you follow procedures for a multiple PI application. Read more at Multiple Principal Investigators.

Prepare a detailed budget if you are applying from a foreign institution or your application involves multiple institutions.

If you propose research at multiple institutions, designate one institution as the prime institution and the other as a subcontract (subaward) to be administered by the prime institution.

If you are preparing a modular budget, submit the budget component for the prime institution only; do not include separate budgets for subawards.  Provide information on the subaward's budget in the budget justification.

If you are preparing a detailed budget, the prime institution submits the Research & Related Budget component. Attach the individual budgets for the subawards separately to the Research & Related Subaward Budget Attachment Form. 

Follow the Grant Application Guide for further instructions.

Follow the instructions in the SF 424 Application Guide and the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement. Don't put anything in the Appendix that belongs in the Research Strategy to circumvent the page limits; if you do, the review of your application may be delayed.

Applying and After

Apply electronically using the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement. Find general information about electronic application in our Applying for a Grant.

For both AIDS and non-AIDS applications, you may submit in September, January, and May. For specific dates, see the NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed) Guide announcement.

No. Check the "No" button in the human subjects section of the PHS 398 Cover Page Supplement.

NIAID's special emphasis panels will peer review it.

Yes, but only for the Investigator(s) and Approach review criteria. In addition to the standard review criteria, reviewers will assess the following factors:

  • Investigator(s). Do the investigator and the clinical trial team demonstrate adequate expertise and ability to develop, organize, manage, and execute the proposed trial?
  • Approach. Are the activities proposed for the planning phase appropriate and adequately described for timely and successful trial implementation? Do the proposed planning activities address major barriers to implementing and completing the clinical trial? Are there adequate plans for the development of an effective organizational structure for carrying out the trial?

Yes, one time. Before resubmitting a revised application, we strongly suggest that you repeat the prior consultation process with NIAID.

Use the results from the previous review to strengthen your project.

No.

You may be able to apply for an extension. You can also take a no-cost extension—read more in the No-Cost Extension SOP.

Also see our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Extension of Investigator-Initiated Clinical Trials Questions and Answers.

If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

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