Roles & Responsibilities — Parallel Processing (PP)
The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
What is Parallel Processing?
Parallel Processing (PP) is the process that supports simultaneous budget development and negotiation, contract negotiation, and IRB review in order to expedite commencement of a study.
RMG will coordinate with the OSR contract office once they receive documents (study protocol, etc.) for a new study from the IRB or the PI. This allows RMG, OSR, and the IRB to begin their review and negotiation processes in parallel, rather than sequentially.
PI and/or Study Coordinator
- Forwards sponsor payment schedule and contact information to RMG.
- Downloads and completes CTRP Workbook, available on the Spectrum website, separating standard of care (covered by insurance) versus research costs (paid by the sponsor and included in the study budget).
- Supplies contact information and draft contract to OSR.
- Establishes initial institutional record for the study and tracks its status until awarded.
- Sends acknowledgement to PI of receipt of study information/application and notifies PI of missing requirements needed to commence budgeting; acknowledgment will also provide the name of the CT RPM who will work with the PI, and the SPO #, the unique institutional designation for every sponsored project.
- Notifies OSR Contracts of new study
- Receives study notification from RMG. Obtains minimum required items from sponsor or PI to begin contract negotiations: 1) draft contract; (2) draft protocol; and (3) PI name.
- Creates log to track status and notifies PI of assigned Contract Officer.
- Begins contract negotiations.
- Communicates with PI or study coordinator as needed regarding contract terms and conditions.
- As needed, consults with RMG or OSR and/or study coordinators on clinical procedures, pricing, regulatory issues, hospital requirements, and clinical and/or operational aspects of the study.