Budget planning should consider per-participant funding for the majority of trial costs. Applicants should budget for site costs for participant visits, study procedures, and personnel time and effort for data collection when calculating overall per participant costs. Consideration should also be given to the costs of recruiting and retaining subjects, including marketing and communication efforts to advertise the trial and engage subjects. For further details, collaboration with the NINDS Program Officials is encouraged.
- Site start-up funds may be provided prior to study initiation but 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 (note: percentages are suggested, not mandatory – percentages should be based on the amount of effort required for various visits and phases of participation). For example:
- 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),
- The final payment (i.e. 25%) to be made when the participant has completed the study and all data is collected from the site.
- Applicants should also budget for a one-day visit to NINDS in Rockville, Maryland, for a study start-up meeting. Key study team members, including the Principal Investigator (and Co-Investigators), lead coordinator/project manager(s) and study statistician, are encouraged to attend. Business office personnel are also invited to attend in person or via teleconference.
The PI may want to consider alternate sites and close down strategies if sites do not recruit, enroll, or retain participants in the agreed upon timeframe.