Enrollment Data Collection Tasks

Since 2002, the National Institute of Neurological Disorders and Stroke (NINDS), has designated its contractor, KAI Research Inc. under NINDS Contract # N01-NS-2-2343, to assist investigators in accurate completion and reporting of enrollment data. To assure high standards of quality data reporting, this task involves identifying and resolving discrepancies on recent enrollment report data submissions.

Please note that all information is collected on behalf of the NINDS, for the sole use of the NINDS, and as such, it is treated in a confidential manner in accordance with HIPAA regulations as no personal identifiers are requested.

In addition to the Target/Enrollment data, NINDS requests that Principal Investigators with projects involving human subjects submit/update supplemental data for each reported project. All data are collected on behalf of the NINDS. The purposes of collecting the information are to:

• Assure the accurate representation of project data.
• Update the NINDS on study recruitment and enrollment progress.
• Assist the NINDS in accurately reporting to Congress and other agencies reviewing their research portfolio progress.

While some information is also part of the annual progress report and/or grant application, the supplemental data form facilitates Institute management and data aggregation for reports to the Office of the Director, NIH and Congress, as needed:

• Lead Study Coordinator Name and contact information
• Enrollment "As of" Date - date which the enrollment numbers represent (not included on the PHS 398 form)
• Date of First Subject Accrual
• Date of Last Subject Accrual
• Date of End of Follow-Up
• Number of DOMESTIC Sites
• Number of FOREIGN Sites

*For FOREIGN sites, investigators should specify country name and # of sites for each country Also if your study is designated as Phase III clinical trial, we ask you to provide information on primary study publication, as it becomes available.

For a complete explanation and history of the NIH gender and minority data collection, please refer to the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects Policy Implementation web page. See also the instructions for human research.