Completed review forms received will be reviewed the following Monday. Please note the deadline for submission to the committees is one week prior to the meeting (i.e. Center City deadline is end of business on the Tuesday @3pm before the meeting.)

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 "Feasibility 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.

Decision Outcomes

The committee will issue one of four decision outcomes:

o   Approved - Study may move forward to PRMC

o   Contingent Approval - May depending on the issues/concerns move forward to PRMC

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 PRMC

o   Tabled - There was no representation present during the review of the trial to answer questions/concerns or there was significant number of department committee members who did not provide input. The trial will be placed on the next available meeting agenda and will be re-reviewed.

A Protocol Feasibility 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 PRMC, any issues/concerns that will need to be addressed prior to activation, or if additional information is needed.