Protocol Facilitation Committee

Protocol Facilitation Committee (PFC) is responsible for determining if an oncology-related study can be conducted with the current resources at the Sidney Kimmel Cancer Center and to identify any logistical issues or concerns that will need to be addressed prior to activation of the study. The Protocol Facilitation Committee is made up of personnel from various departments that could potentially be involved in the study.

For questions, please contact the Protocol Facilitation Committee (PFC) Coordinator at 215-955-3698 or via e-mail at sxs181@jefferson.edu.

 

All oncology-related studies that require Multidisciplinary Disease Group (MDG) approval are required to be submitted, reviewed, and approved at the Protocol Facilitation Committee prior to submission to the Protocol Review Committee (PRC) and Institutional Review Board (IRB). Note that any issues and/or concerns that are identified by the committee must be addressed before the study can be activated for enrollment.

The committee meets every Monday at 1pm at the Clinical Research Organization (CRO) Conference Room (1015 Chestnut Street, Suite 700, Philadelphia, PA 19107) and is facilitated by the CRO Protocol Support Unit (PSU).  

 

Submission Requirements

After a trial has received MDG approval to move forward, the MDG coordinator or designated personnel is required to submit the following document to the PFC Coordinator:

 

Completed review forms received by close of business on Monday will be reviewed the following Monday. The PFC Coordinator will retrieve the protocol and any additional applicable documents (e.g., lab manuals) from JeffTrial.

The Tuesday before the scheduled meeting, the PFC Coordinator will send an e-mail with the protocol(s), the Review Form(s), and any additional applicable documents, attached, of the studies being reviewed at the next meeting. The subject line of the e-mail will read "Facilitation Committee Meeting Agenda". A study team representative from each of the studies being reviewed must be in attendance at the meeting to answer any questions that may arise. If a study team representative is not present the trial will be tabled.

Decision Outcomes

The committee will issue one of four decision outcomes:

o   Approved - Study may move forward to PRC

 

o   Conditional Approval - May depending on the issues/concerns move forward to PRC

 

o   Deferred - Additional information is needed before a decision can be made. Must come back to the full committee for review.

o   Disapproved - Trial will not move forward to PRC

A Protocol Facilitation Committee decision e-mail will be sent to the Principal Investigator, MDG coordinator/designated person, and any additional personnel noted on the Review Form (e.g., PSU Regulatory Manager). The e-mail will contain the outcome decision, whether the trial can move forward to PRC, any issues/concerns that will need to be addressed prior to activation, or if additional information is needed.

Workflow

Facilitation Committee Flowchart

10/11/2016

Submission Form

Protocol Facilitation Committee Review Form

07/24/2018