Protocol Review Committee/Data Safety Monitoring Board
The Thomas E. Starzl Transplantation Institute (STI) Protocol Review Committee (PRC)/Data Safety Monitoring Board (DSMB) provides oversight of clinical research protocols involving STI patients. This decision-making body assembles into two groups based on responsibilities and function: 1) Protocol Review Committee and 2) Data Safety Monitoring Board. The charges of each are the following:
Protocol Review Committee Charge
The STI PRC rigorously reviews and approves all proposed clinical research protocols involving STI patients prior to submission to the University of Pittsburgh Institutional Review Board (IRB). The primary charge of the STI PRC is to ensure that the protocols are of the highest scientific merit, appropriate research design and methods, no unnecessary risks to participants, acceptable use of resources available at the STI, and highest quality when submitted to the University of Pittsburgh IRB.
Data Safety Monitoring Board Charge
The STI DSMB provides at least yearly review and approval of all IRB-approved research protocols, consent forms, and data safety monitoring plans involving STI patients. Once the study is approved by the University of Pittsburgh IRB, the DSMB charge is to
- evaluate the progress of the study,
- review all study related adverse and unanticipated events and protocol deviations,
- assess data quality and timeliness,
- determine if the risk-to-benefit ratio remains favorable,
- review participant recruitment and accrual rates,
- protect subject safety,
- ensure confidentiality of subject participation and data,
- appraise STI’s performance in the study,
- evaluate the ethics of the study in relation to new and relevant information,
- review study-specific data safety monitoring plan adherence and documentation of data safety monitoring meetings by the study team, and
- provide recommendations for corrective actions to the principal investigator.
Based on information that warrants action, the DSMB has the authority to suspend accrual or further administration of investigative treatments in any clinical study at the STI. Meeting Location: Montefiore University Hospital Berkman Board Room. Meetings are open to board members only.
Thomas E. Starzl Transplantation Institute (STI) Protocol Review Committee (PRC) Data Safety Monitoring Board (DSMB) meeting dates and submission deadlines are as follows:
Deadline for submission to the STI PRC/DSMB is 12 days before the scheduled meeting date. Any PRC protocols or DSMB reports that do not have the required documentation for review will not be placed on the agenda for the meeting. All data safety monitoring plans not requiring STI DSMB full board review may be submitted at any time for review within seven (7) days of receipt. Additionally, the 6 to 8 week submission deadline for the University of Pittsburgh Institutional Review Board must be taken into account when submitting materials to the STI PRC/DSMB to prevent protocol expiration.
No exceptions will be made to the STI PRC/DSMB submission deadlines and review process.
Protocol Review and Data Safety Monitoring Review Process
All new protocols (including Exempt and Expedited studies) involving Thomas E. Starzl Transplantation Institute (STI) patients require protocol review and approval from the Thomas E. Starzl Transplantation Institute Protocol Review Committee (PRC) prior to submission to the University of Pittsburgh Institutional Review Board (IRB).
All data safety monitoring plans and progress reports involving STI patients require yearly (more frequently if necessary) review and approval by three members of the Thomas E. Starzl Transplantation Institute Data Safety Monitoring Board (DSMB) prior to submission to the University of Pittsburgh IRB. All IRB-approved protocols involving STI patients that require a data safety monitoring board will require yearly (more frequently if necessary) STI DMSB full board review and approval prior to submission to the University of Pittsburgh IRB.
- The STI PRC/DSMB meets on the second Monday of each month to review protocols, data safety monitoring plans, and progress reports. See FY2013 Meeting Dates and Submission Deadlines for submission schedule and meeting dates.
Deadline for submission to the STI Protocol Review Committee and full board DSMB is 12 days before the scheduled meeting date. Any protocols or data safety monitoring plans that do not have the required documentation for review will not be placed on the agenda for the meeting.
Data safety monitoring plans and progress reports not requiring STI DSMB full board review can be submitted at any time to the STI DSMB for review and approval.
Additionally, the 6 to 8 week submission deadline for the University of Pittsburgh IRB must be taken into account when submitting materials to the STI PRC/DSMB to prevent protocol expiration.
No exceptions will be made to the STI PRC/DSMB submission deadlines.
- Complete an STI PRC Submission Form and submit with your proposal. Required documents are the following:
- a completed PRC Submission Form
- a completed Data Safety Monitoring Plan Progress Report (at annual renewal or more frequently if required)
- a copy of a full protocol and/or OSIRIS protocol
- consent form(s)
- investigator’s drug brochure, if applicable
- IRB required forms
- for multi-center studies, a coordinating center DSMB report
- Submit all documents electronically to:
Beth Elinoff, RN, MPH, CCRC
Thomas E. Starzl Transplantation Institute
E1540 Biomedical Science Tower
200 Lothrop Street
Pittsburgh, PA 15261
Telephone: (412) 624-6611
FAX: (412) 624-6666
- Results of the STI PRC/DSMB review will be sent electronically to the principal investigator of the protocol no later than five business days after the scheduled meeting or within 10 business days of a DSMB plan and progress report review which does not require full board review.
The STI PRC/DSMB may request additional information or clarifications to questions generated at the meeting. Your timely and thorough electronic responses to these questions will assist with your proposal being approved quickly. Approval of the protocol will not be granted until all questions/clarifications have been addressed and the committee has accepted the responses.
Any administrative modifications to an approved protocol require STI PRC/DSMB notification. Any modifications that alter the originally approved study design or experimental procedures will require STI PRC review.
All protocols approved by the STI PRC require at least annual review by the STI DSMB.
No exceptions will be made to the STI PRC/DSMB Review Process.
Below are the PRC Protocol Submission form and the DSMB Data Safety Monitoring Plan Progress Report form.
The attached documents provide membership requirements, meeting requirements, and guidelines for protocol review.
2011-2012 PRC/DSMB Membership Roster
Fadi G. Lakkis, MD
Amit Basu, MD
Diana M. Metes, MD
Stephenie Dermont, RN
Leslie Mitrik, BS
Beth Elinoff, RN, MPH, CCRC*
Seo Young Park
Shelia Fedorek, RN, CCRC
Beata Pasek, BS
Christopher Hughes, MD
Parmjeet Randhawa, MD
Darlene Koritsky, RN
Ron Shapiro, MD
Susan Lamson, RN
Amy Steele, RN
Roberto Lopez, MD
Raman Venkataraman, PhD
Alisha Maslanka, BS
Jennifer Woodward, PhD
George Mazariegos, MD
*STI PRC/DSMB Coordinator