Dear All,
Please see below information from Tess Cummings, Director for the UNC Lineberger Clinical Protocol Office. Tess has done an outstanding job in pulling the SIP process and requirements together, her tireless efforts are much appreciated.
Many thanks,
Christine Nelson
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Good Morning UNC Research Community,
As many of you have heard, several sponsors (Roche, BMS, Merck, Lilly, Pfizer) have been working with a company called Cognizant to create the SIP over the past few years. Although the original intent of the platform was for sites to create a profile for feasibility and site selection purposes, many of these sponsors are now requiring the use of this platform for document exchange and sharing of essential documents associated with studies.
The roll out of the use of SIP has not been standardized or consistent on either the sponsor or site sides. To remedy this, in discussions with the Office of Clinical Trials we have decided to implement some ground rules for the management of this system across the UNC research community. Specifically, the decision has been made to create the following structure for UNC:
- Organization = University of North Carolina
- Facilities = primary locations where research will be performed
- Departments = research groups who will be performing the research
For example, oncology research has been established as a department titled Lineberger Comprehensive Cancer Center and the facility being University of North Carolina Medical Center.
In the absence of any guidance, many folks have established a presence in SIP in a variety of ways. I will be working with these groups to fold them into the structure described above over the next few weeks. It will involve transferring the people and studies associated with the initial set up into the new departments I will be establishing. Cognizant has walked through this process with us for the Center for Inflammatory Bowel Disease team earlier this week and it was relatively painless. One key insight revealed is that it is possible for the PI to not only delegate profile set up to another member of the team, but also waive the requirement for PI approval of all future changes made for the study in the system. I am including screen shots provided by Cognizant for how to complete this task for PI’s who are already established in the system.
Departments will be tied to their identified primary facility where research is performed, however when creating the 1572 in SIP during study set up, you will have the ability to add additional locations as needed. Including some slides provided by Cognizant to illustrate how information flows from SIP into the 1572.
I am also including the webinar schedule found on the SIP webpage and would encourage you to attend the applicable sessions to learn more about the system. I thank you in advance for your patience and understanding as we work through this. Feel free to reach out to me if you have any questions.
Associated Documents: SIP Capabilities by Sponsor, How Information Flows into SIP-generated FDA Form 1572, Webinar Schedule Q4, Steps to Set User Profile Flag
Theresa (Tess) Cummings RN, DBA, CCRP
Director, UNC Lineberger Clinical Protocol Office
Senior Clinical Research Advisor to the UNC Office of the Vice Chancellor for Research