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Applicant Interview or "Reverse-site visit"

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Some clinical trial or large clinical research applications may receive an applicant interview before the NINDS clinical trials study section reviews the application. The purpose of the applicant interview is to allow the investigators the opportunity to address any questions the reviewers may have about the application prior to the review at the full study section meeting. Generally the large applications (greater than $1 million dollars per year) are given an applicant interview based on their complexity and financial investment, however a final decision is made at the discretion of the NINDS scientific review branch. Applicant interviews are conducted as follows:

  • The primary reviewers assigned to the application first meet in a closed "executive" meeting to highlight areas of concern that need to be clarified during the interview with the applicants and the members of the clinical trial review group. The applicants will be expected to provide the final study protocol and the latest versions of their manual of operations and data collection forms, including a model consent form.

  • The applicant interview will precede with a brief 30-minute presentation by the principal investigator and/or selected members of his/her group. This will be followed by a question and answer period by members of the review committee. The interview typically lasts about 3 hours.

  • Following the interview, the committee will deliberate to assess the scientific and technical strengths and weaknesses of the application and report their findings and critiques to the full study section where the application will be discussed and scored.

 

Last updated April 20, 2007