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FoxChaseCancerCenter

Process for New Protocol Review

I. Scientific Review - Research Review Committee (RRC)

A. Once a study has received departmental approval the PI must complete aRequest for New Protocol Review Formand is responsible to submit the original request along with 4 copies of the request form and new protocol to the PMO Regulatory Coordinator for submission to RRC.

1. Pharmaceutical Sponsors must be instructed to send new protocols to the PIand not directly to the PMO.

2. FCCC Investigator-Initiated protocols must include draft and/or version numbers/dates on the title page.

B. The PMO Regulatory Coordinator for RRCwill check that the Request for New Protocol Review Form and protocol packets are complete; the protocol will be assigned to the agenda for the next available RRC meeting.

1. RRC meetings are held on Wednesday mornings

C. RRC Meeting Outcome:

1. Approved – Steps in section II will be followed

2. Not Approved – PI response to RRC Reviewer comments required

a. Following the RRC meeting, the PMO Regulatory Coordinator for RRC will send the RRC reviewer comments andrecommendations to the PI, using a standardized review template also known as the “RRC Grid”.

b. The PI must respond point-by-point in a written response to the reviewer comments and forward the response to the PMO Regulatory Coordinator for RRC no later than 90 days from the RRC meeting. PI response must include any correspondence from the Sponsor and, if applicable, a revised protocol document.

c. The PMO Regulatory Coordinator will forward the PI response and corresponding documents to the RRC Chairperson for re-review. The RRC Chairperson may review with individual RRC members or the full Committee, as appropriate. The PI may be asked to provide supplemental written responses until RRC approval is attained or the protocol is withdrawn.

d. Full RRC approval requires a finalized protocol and written response to all RRC comments and recommendations.

e. If protocol changes are made as a result of theinitial RRC review, the mostcurrent version of the protocol, with a summary of all changes, must be submitted to the PMO Regulatory Coordinator as the final version for RRC review and approval.

f. The RRCChairperson will review the final version, and determine if further review by individual RRC members or the full Committee is indicated.

g. If changes are made to the protocol afterRRC approval the changes must be submitted to the PMO Regulatory Coordinator to be processed as an amendment and submitted to the RRC Chairperson for review and approval prior to IRB approval.

h. Upon final RRCapproval steps in section II will be followed.

D. Upon receipt of RRC approval the PMO Regulatory Coordinator will begin to prepare essential documents, i.e. 1572’s, CV’s, Medical Licenses, Financial Disclosures, lab certifications and lab normal reference ranges; the Regulatory Administrative Assistant will assemble a study specific Regulatory Study File in accordance with the PMO standard operating procedure.

II. Institutional Review Board (IRB), Informed Consent (ICD), HIPAA

A. Once the new protocol is approved by the RRC, the PI forwards the study specific Informed Consent Document (ICD) to the PMORegulatory Coordinator in electronic format.

1. Investigator-Initiated studies – the PI is responsible to draft the ICD using the required FCCC IRB template available on the IRB website:

2. External Sponsor Initiated studies - the PMO Regulatory Coordinator will incorporate the content of the Sponsor ICD into the required FCCC IRB template.

a) Once the Sponsor content is merged into the FCCC ICD template the document will be sent to the PI and the Sponsor for review and approval.

B. The PMO Regulatory Coordinator will prepare and compile all requiredstudy packetsfor IRB submission and assign the study to the agenda for the next available IRB Meeting. The FCCC IRB meets twice monthly on Tuesday afternoon; the IRB meeting schedule is available on the IRB website:

1. Study packets and the proposed agenda must be submitted to the IRB10 days prior to the IRB Meeting.

2. The PMO Regulatory Coordinator will begin to forward the required essential study documents tothe sponsor and retain copies for the Regulatory Study File.

3. The IRB will issue the official meeting agenda

C. IRB Meeting Outcome:

1. Approved – the IRB will distribute the written IRB Approval Notification. The PMO Regulatory Coordinator will process the approval in preparation for activation. The PI, PMO Study Team, and Sponsor will collaborate to plan a Study Start-Up Meeting. The PMO Study Team will work with the PI in preparation for study activation. The PMO Regulatory Manager will activate studies only at the request of the PMO Study Team.

2. Approved –Contingent upon specific Revisions/Clarifications – The IRB will send the PI an IRB review memo listing the required changes. The PI will work with the PMO Regulatory Coordinator to address recommended changes to the ICD. The PMO Regulatory Coordinator will incorporate the IRB recommended changes into the ICD and forward to the PI and Sponsor for review and approval prior to resubmission to the IRB; once PI and Sponsor approval is received the PMO Regulatory Coordinator will resubmit to the IRB. Recommended changes or clarifications to the protocol will need to be addressed in writing by the PI and submitted directly to the IRB.

3. Disapproved or Tabled – The PI submit a written response to the IRB and the study will need to be re-reviewed by the Full Board IRB.

III. Duties of the PMO - Regulatory Following IRB Approval

A. Forward the IRB meeting minutes to the study team as soon as they are published.

B. Forward the final IRB approval letter to the sponsor if applicable.

C. Activate the study in PMS once they have received notice from the study team.

September 10, 2018Created by Joanne Ley