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Policies for Grant Submissions
Types of Research Submissions
Funded Research – PI is not in the Department of OB-GYN
- A research application and Department of OB-GYN Funded Research – PI is not in the Department OB-GYN Submission Checklist must be submitted to the Division Director for review and signature before an investigator can present the application to the Department Administrator and Chairman for sign-off.
- The investigator should discuss suggestions for budget negotiations (salary support, travel, phone, secretarial support, and so on.) with the Grants Manager.
- The Department Administrator must review and sign all research applications before submitting to the Chairman for sign-off.
- When submitting a research application for the Chairman’s signature, include the Department of OB-GYN Funded Research – PI is not in the Department of OB-GYN Submission Checklist, and copies of the GCO cover page (GCO Form 1), budget, and protocol summary (GCO Form 4) for the departmental file. This package should be submitted to Monika Mittelholzer.
- Sign-off time for the Chairman: 24 to 48 hours.
- If there are any budget changes or significant protocol revisions after the department has signed off on a research application, they must be reviewed with the Division Director, the Department Administrator, and Grants Manager.
- After a study is approved by the IRB, the investigator must submit a copy of the IRB approval letter to the Grants Manager for the departmental files.
- Investigators must maintain complete and well-organized files of all IRB submissions (including all IRB submissions, all IRB correspondence, all correspondence with the sponsor, all Clinical Study Agreements, and all approved ads). These files should be organized chronologically by IRB approval year, and should be available for review if there is an internal or external audit.
- Departmental oversight will include internal audits.
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