Study Initiation Program
A joint program of the Human Research Protection Office (HRPO) and Office of the Vice Chancellor for Research (OVCR), the goal of the Study Initiation Program is to:
- Create a collaborative working relationship with researchers that provides for open communication and support of the ethical conduct of human subjects research.
- Provide protocol-specific, on-site education to Principal Investigators and their research teams to support the conduct of research in compliance with federal regulations, state law, institutional policies, and “best practice” procedures.
The Study Initiation Program is available through request or referral. (To make a request, please call HRPO SWAT! at 314-747-6800.) During these visits, representatives of the Human Research Protection Office (HRPO) and the Office of the Vice Chancellor for Research (OVCR) will provide materials regarding regulations, policies, and best practices designed specifically for your study.
The Study Initiation Program currently offers four types of visits for approved human subjects research protocols:
- Study Initiation Visit – For investigators new to WU, conducting human subjects research in new fields or disciplines, or simply wanting an update on the state of the art in research administration at WU.
- Multisite Study Initiation Visit – For investigators conducting their first multisite study or simply wanting advice about implementing an approved multisite study.
- Transition Study Initiation Visit – For investigators taking oversight as principal investigator for a study that has already been approved and implemented at WU. This visit will provide study-specific about what an investigator should be aware of during the stage of transition.
- IND or IDE Study Initiation Visit – If you are the holder (“sponsor-investigator”) of an IND or IDE at WU, our policies require that you attend a brief training session covering your responsibilities as the sponsor-investigator. This is very informal session that takes between 30 and 60 minutes. During this conversation we will talk about FDA-required reporting, data management practices, research team and/or clinical site management, and helpful additional resources.(HRPO is also available for consultation on questions about research involving investigational drugs or devices prior to submission to the IRB. Please contact us through SWAT! On Call, or visit us at Office Hours with your questions.)