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This template may be used for each clinical site, in addition to this template, information required under the funding mechanism of choice should be provided. This template is intended to be used to help the principal investigator, clinical site investigators, program staff, and reviewers better understand how funds will be distributed overall, within and between clinical sites, and throughout the duration of the trial.

Key Points:

• List the site investigator and the institution for each clinical site under "Key Personnel" on page 2. Each clinical site should provide information to the PI as number of potential participants they expect to contribute to the clinical study - additional information on what should be provided can be found in the NIH Guide Notice "NINDS Guidelines for Enrollment of Subjects into NINDS-Funded Clinical Trials" ( http://grants.nih.gov/grants/guide/notice-files/NOT-NS-05-010.html)
• For some studies start up funds may be provided, this should not exceed $5,000 per site; this funding is intended to carry the site through the enrollment of the first participant.
• Some studies forward fund each site, a certain amount of money to cover the cost of the first 2 - 3 patients; the PI should consider this scenario and the impact of providing funds to sites that may not perform as planned.
• Funding on a per participant should be broken down into phases such as a certain percent of the total per participant cost for screening and enrollment (i.e. 25%), a certain percent for each follow-up visit and completion of forms (i.e. 5 - 10% per visit depending on how long the study is and how often the participant is seen for follow-up), and the final payment (i.e. 25%) should be made when the participant has completed the study and all data is collected from the site.
• The PI may want to list in the funding application to consider if sites do not recruit, enroll, or retain participants in the agreed upon timeframe.

Last updated April 20, 2007