View/Read:

• GCRC Application Instructions

• DSMP

• GCRC Notices

Download:

• Protocol PHS 398 Template

• Resource Request Form

Link to:

• NIH Biosketch Form

• IRB Human Subjects Training

• IRB Forms

• Other Useful Links

 Last Modified: 10/11/03

Following written approval by the GAC an Initiation Meeting with the GCRC staff must occur before a study starts on the GCRC. This meeting helps to orient the GCRC staff about what the study entails and better prepares them to support the study.

For studies that require nursing services a primary and secondary study nurse will be assigned to each protocol. The protocol nurse serves as a liaison between the GCRC and the investigator and staff, and is expected to become familiar with all study procedures and be a source of information for other GCRC staff.

Development of study flow sheets. The PI may meet with the nursing staff to create study flow sheets in advance of the Initiation Meeting. Flow sheets and standard orders are important to ensure implementation of the study according to the study protocol.

If a study requires dietary support, the GCRC Bionutritionist or a member of her staff will need to attend the meeting. For studies with complex or major dietary requirements, it may be important to meet separately with the Bionutritionist before the Initiation Meeting, and preferably during the design of the study.

Protocol Initiation Guidelines

Please schedule a protocol in-service at x29542. We would like to learn:

• Study rationale and brief overview

• Name and contact number/pager of responsible M.D.

• Inclusion and exclusion criteria

• Criteria to stop/intervene with study

• Any staff education to be done (such as use of special equipment)

• What you need from us before the study (M.D. orders, equipment, supplies...) and

• during the study

• Anticipated side effects or reactions

• Expected duties of each team member

• Dietary requirements

• Any other needs