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Clinical Trial Planning and Implementation Milestones
Updated May 15, 2015
This page describes administrative aspects that usually need to be in place before initiating a U01 clinical trial application. They represent milestones that must be reached for successful completion of a NIAMS U34 Clinical Trial Planning Grant and before proceeding to opening for participant enrollment in a funded study.
The NIAMS recognizes that planning and administrative activities for starting a trial can vary based on the type of study being conducted. For example, regulatory approvals for a Phase III multi-site study of a new therapeutic agent will differ from a trial of a behavioral intervention or a device. An application for a U34 should provide a list of the milestones that must be met before the implementation of the proposed trial can begin, and a plan for reaching these milestones. Prior to awarding a U34 grant, the NIAMS will work with investigators to agree on a timeline for accomplishing these tasks.
Milestones that may be appropriate for a U34 may include, but are not limited to:
- Identify study collaborators and convene meetings to finalize protocol development
- Complete clinical protocol (allowing for subsequent changes by regulatory bodies)
- Budget plan. If requesting funding through the NIAMS, details in the requested budget should include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), indirect costs, and total costs for each year of the requested application. PLEASE NOTE: Applicants with budgets with direct costs greater than $500,000 in any year must request permission to submit the application. See Letters of Request.
- Identification and qualification of clinical trial enrollment site (s), data coordinating center (DCC), Clinical Research Organization (CRO), pharmacies and laboratories
- Clinical Trial Agreement (CTA) and/or Cooperative Research and Development Agreement (CRADA), when applicable
- Investigator’s Brochure or equivalent for study intervention
- Manual of Operations (see NIAMS Single Site MOOP Guidelines or Multisite MOOP Guidelines)
- Data and safety monitoring plan (which is also included as part of the MOOP)
- Data management/collection system for primary and remote sites, including case report forms and electronic system(s)
- Plans and materials for training and site initiation
- Consent/assent forms
- Plans and timeline for submission to Institutional Review Boards (IRBs) and receiving approvals
- Plans and timelines for meetings and submission of documents (e.g., IND or IDE requests) to appropriate regulatory bodies (e.g., the Food and Drug Administration)
- Finalize plans to obtain intervention related products (e.g., drugs, placebo, device)
- If drug or biologic, availability, acquisition and formulation, including placebo, where applicable
- Documentation of adequate co-funding, if applicable and necessary for completion of the trial
- The proposed date of submission of the U01 application
One of the goals of the NIAMS clinical trials programs is to fund timely trials. Thus, NIAMS will strive to minimize any delay between the planning and implementation phases of a trial. To this end, certain milestones will be identified for each U34 which, when reached, would be sufficient to permit the investigator to submit an application for a U01. Most planning milestones should be accomplished prior to submission of an application for funding for implementation of a trial. Please note, once these milestones are met, it may be appropriate to submit the application for the U01 even if it is before the end of the planning grant, with an agreement that certain tasks would be completed in the remaining period of U34 grant funding. Consultation with the appropriate Program Officer is strongly encouraged, as described here.
NIAMS policy is that a U34 Clinical Trial Planning Grant be obtained before proceeding to a U01 Clinical Trial Implementation Grant. However, when the planning process has already been completed through other means, for example by a previously funded R34 grant or with private funding, an investigator may wish to apply directly for a U01 without a preceding NIAMS U34.
Clinical Trial Planning Milestone Checklist and/or Requests to Waive the NIAMS U34 Planning for a Clinical Trial Implementation (U01) grant application
In cases where the clinical trial planning milestones have been completed (either through the NIAMS U34 planning grant or other means), applicants should submit a Clinical Trial Planning Milestones Checklist to demonstrate the necessary planning accomplishments. The checklist summarizes each of the planning Milestones and provides a status and timeline of each task. Any tasks that remain incomplete before the trial can open for recruitment must be detailed and justified. Applicants should consult with a NIAMS Program Director or Clinical Research Manager to determine if the NIAMS will consider a U34 waiver request. Please note that the NIAMS may also ascertain that substantial additional planning is necessary and not grant a waiver to the U34 requirement. Those applicants will be directed to apply to the Clinical Trial Planning Grant (U34) Cooperative Agreement FOA and delay submission of the U01.