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.

The following steps outline the planning process:

1. Review Clinical Trial Policies & Schedule a Consultation

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 R34 grant funding. Consulting with the appropriate Program Officer is strongly encouraged. Schedule a consultation.

2. Select Appropriate Funding Opportunity

If applying to an R34, review the Milestones. 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 R34 which, when reached, would be sufficient to permit the investigator to submit an application for a U01. Review the Milestones.

If applying to a U01, complete the Milestones Checklist. In cases where the clinical trial planning milestones have been completed (either through the NIAMS R34 planning grant or other means), applicants should demonstrate planning accomplishments by submitting a Clinical Trial Planning Milestones Checklist. Complete the Milestones Checklist.

3. Review Policies, Guidelines, and Templates

Research that involves human subjects requires the NIH to focus on the protection of human subjects and study integrity. Therefore, the NIAMS has developed guidance documents to help Investigators meet the required NIH, Institute and other federal requirements for safe, ethical, and high quality clinical research.  Review NIAMS policies and guidelines.

For more information or questions, contact a NIAMS Clinical Research Manager:

Shahnaz Khan, MPH
Clinical Research Manager, Extramural Program
NIAMS, NIH
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone: 301-594-2463
Fax: 301-480-4543
Email: khanshah@mail.nih.gov