Nursing Process Explanation/Study Initiation on the Clinical Services Unit
1. During planning/application stage
Arrange for an “Effort Analysis”, an estimate assessment meeting between the PI/designee and the Clinical Services Core Nurse Manager Deanna Palma, 801-581-2224. This important meeting should be held before the Internal Advisory Committee (IAC) reviews your protocol, so please plan accordingly.
The CSC nurse manager will meet with each applicant investigator to evaluate nursing effort, total CSC visit time, per patient number of visits and types of visit, and other required services for their protocol. Ideally, this face-to-face effort assessment should occur earliest in the planning stage for any study that may use the CSC, and must be completed before the protocol can be considered for performance in the CSC.
2. After your application receives IRB and CCTS IAC approval:
- Ensure all research staff are CITI trained
- Forward all approved/stamped consent documents via email to CCTSconsents@hsc.utah.edu
3. Contact your CCTS protocol manager (PM), a clinical services core RN assigned by nurse manager at time of application, 801-581-2224.
4. Schedule a Protocol Activation Meeting (PAM) with your PM, 801-581-2224.
*If your study requires an industry site initiation visit, please make arrangements with the clinical nurse educator
5. Request access to the scheduling template and shared outlook calendar: CCTS Scheduling.
6. Begin scheduling participants IF
- Your protocol activation meeting is held; you must have all action items from the meeting resolved to PM satisfaction prior to first participant visit date on the CSC.
- All participants have protocol-specific, signed MD orders prior to their visit. Your PM will work closely with your study coordinator to be certain that all specific research data points or treatments are described correctly.
- All participants have signed consent/assent documents on the CSC unit prior to study activity. Email signed copies to CCTSconsents@hsc.utah.edu.
Your PM is your primary contact for any questions, 801-581-2224