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Requirement for No-cost Extension Progress Reports


Clinical research projects that require additional time to complete such project through a no-cost extension will be required to provide a progress report and summary of human subject participants if the study is ongoing, any participants are still being treated or followed, and if data analysis is not completed. This change in procedure is to insure that the NINDS staff have adequate documentation that human subject protection and quality data monitoring is being performed. Investigators are required to provide a progress report to the NINDS program director no more than 90 days from the end of the project period and yearly thereafter. A copy of the IRB approval and gender minority tracking should be included as part of the progress report.

Any changes to the protocol, consent form, or other study documents should be sent to the Program Director as they occur.

Last updated November 24, 2008