Guidelines for the continuation process with the UPCI after PRC Approval
- Submit a yearly progress report to the DSMC via email to Brandon Kaukus, BS, DSMC Coordinator, at kaukusbm@upmc.edu for review and approval prior to submitting to the IRB. The Progress Report form can be obtained from this website.
- IRB Approval, Renewal, modifications and open to accrual should be sent to Priscilla Fello, Database Administrator at fellopj@upmc.edu for inputting to the UPCI Clinical Trials Management Application (CTMA) database.
- In order to maintain updated information such as registration, case report forms, etc. in the CTMA, please review the listed information in the "Data Submission" section below
Data Submission Guidelines
Data must be submitted according to the protocol requirements for all patients registered to UPCI clinical trials.
Data forms, including registration forms, status change forms and case report forms for UPCI protocols are available for download below. All necessary forms are contained in the .zip file.
Registration and status change forms should be submitted by fax within seven days of patient registration or status change. All other data forms should be submitted within 14 days of study visit.
Completed data forms should be submitted to:
Clare Grzejka, RN, BSN
Manager, Data & Quality Improvement
Hillman Cancer Center
Suite A410.11
5115 Centre Avenue
Pittsburgh, PA 15232-1305
Fax: 412-647-0949
For more information on data submission, please contact Clare Grzejka at grzejkac@upmc.edu or by phone at 412-623-4891.
Download
- DSMC Progress Report template (.doc format)
- Form Packet (860k, .zip file - Windows users may need to install a decompressing program such as FreeZip