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What is the Penn State Cancer Institute Protocol Review Committee (PRC)?

Cancer-related clinical trials conducted by Penn State Health and Penn State College of Medicine investigators must be reviewed by the Protocol Review Committee.

This website provides investigators with the resources, tools and forms needed to submit a cancer-related study for review. Investigators should carefully review the meeting schedule to ensure studies are reviewed in a timely manner.

Working with the PRC

  • The Penn State Cancer Institute Protocol Review Committee (PRC) is a group comprising basic scientists, clinical investigators and population scientists whose responsibility is to scientifically evaluate and prioritize all cancer center trials derived and supported from institutional sources, including those originating from other cancer centers or from industry.

    PRC’s goal is to match protocols with institutional missions and to review trial methodology, statistical validity and need for ongoing monitoring of risk for studies of cancer patients at Penn State Cancer Institute.

    The primary goal of the Penn State Cancer Institute PRC is to ensure that the trials under its purview:

    • are scientifically and statistically sound;
    • are appropriately designed;
    • are feasible to complete enrollment;
    • include an adequate data safety and monitoring plan; and
    • are congruent with the goals of the Cancer Institute.
  • Initial Approvals

    The PRC conducts an initial review of all cancer clinical trials as well as monitoring for accrual and ongoing scientific validity.

    Full board review and approval are required for investigator-initiated and industry-sponsored trials.

    Expedited review by the PRC chair or vice chair may be sufficient for trials that have undergone prior review by CTEP, NCTN or other NIH peer-review mechanisms. See details on exempt, expediated and full reviews here.

    Approval by the PRC is required prior to protocols receiving approval by the IRB, except for industry and cooperative group studies, which may be submitted concurrently on the condition that these studies must not be activated unless PRC approval is granted.

    Annual progress reports

    All studies to which NCI Data Table 4 applies are required to submit an annual progress report to the PRC if the study was approved by the IRB and activation took place at least six months ago.

    The PRC coordinator will contact study teams at the appropriate time with annual review information.

    Note: Suspended studies are not exempt from submitting an annual report.

    Investigators who are not sure what type of review their study first received or whether an annual progress submission is required should email the PRC coordinator at PSCI-PRC@pennstatehealth.psu.edu.

  • This searchable directory provides a quick reference to the many tools, forms and resources described elsewhere on this page.

  • Meeting schedule and process

    The Protocol Review Committee meets on the second and fourth Tuesday of each month.

    In order for a PRC meeting to convene, there must be a quorum – a number of voting committee members in attendance equal to at least half the number of full members on the committee. In addition, at least one of the chairs and at least one statistical reviewer must be in attendance to constitute a quorum.

    Investigators are invited to the meeting to answer any questions from the committee, and the group encourages investigators to attend or send a study representative.

    Deadlines

    Studies will not be reviewed until all paperwork is submitted.

    Documents are due 10 days before the relevant PRC meeting to allow sufficient time for review. Exempt and expedited studies will be reviewed as soon as documents are received. See details on exempt, expedited and full reviews here.

  • New interventional or therapeutic study reviewed by Disease Team
    Study undergoes feasibility review
    Study submission to Clinical Trials Office
    Study submission to PRC
     
    PRC completes full review for interventional, therapeutic and non-therapeutic non-peer-reviewed studies (see full review details)

    Industry studies may be submitted for concurrent IRB review at this time

    or
    PRC completes expedited review for NCI/cooperative group and CTEP studies (see expedited review details)

    All such studies may be submitted for concurrent IRB review at this time


    PRC approves study
    Study submission to IRB
    IRB approval received
    Study activated
    PRC conducts continuous review of the study
     
    For interventional studies, if Penn State Cancer Institute is the DSMC of record:

    DSMC conducts continuous review of interventional studies

    or
    For interventional studies, if Penn State Cancer Institute is not the DSMC of record:

    DSMC of record conducts continuous review of interventional studies

  • New studies

    All oncology-related studies, with no exceptions, must be submitted to PRC for review and approval before IRB submission.

    Email PSCI-PRC@pennstatehealth.psu.edu for this form

    Amendments

    Protocol amendments that affect the principal elements of the original protocol – including but not limited to: study rationale, response criteria, eligibility criteria, objectives, study design, treatment plan, sample size, stopping rules or statistical plan – must be submitted to PRC for review and approval.

    With questions about changes in an amendment that are not listed among these aspects, email the PRC coordinator at PSCI-PRC@pennstatehealth.psu.edu.

    Note: Amendment submission is not required for NCTN studies and studies sponsored by other NCI-designated (or comprehensive) cancer centers with Penn State Cancer Institute as a participating site.

    Complete the amendment submission form here

    Retrospective Studies (Chart Review)

    A retrospective study looks backward and examines exposures to suspected risk or protection factors in relation to an outcome that is established at the start of the study.

    Retrospective studies can include analysis of existing samples from the Institute of Personalized Medicine biorepository or retrospective chart review.

    Retrospective studies require a short PRC submission form.

    Complete the retrospective study form here

The Penn State Cancer Institute Protocol Review Committee (PRC) is a group comprising basic scientists, clinical investigators and population scientists whose responsibility is to scientifically evaluate and prioritize all cancer center trials derived and supported from institutional sources, including those originating from other cancer centers or from industry.

PRC’s goal is to match protocols with institutional missions and to review trial methodology, statistical validity and need for ongoing monitoring of risk for studies of cancer patients at Penn State Cancer Institute.

The primary goal of the Penn State Cancer Institute PRC is to ensure that the trials under its purview:

  • are scientifically and statistically sound;
  • are appropriately designed;
  • are feasible to complete enrollment;
  • include an adequate data safety and monitoring plan; and
  • are congruent with the goals of the Cancer Institute.

Initial Approvals

The PRC conducts an initial review of all cancer clinical trials as well as monitoring for accrual and ongoing scientific validity.

Full board review and approval are required for investigator-initiated and industry-sponsored trials.

Expedited review by the PRC chair or vice chair may be sufficient for trials that have undergone prior review by CTEP, NCTN or other NIH peer-review mechanisms. See details on exempt, expediated and full reviews here.

Approval by the PRC is required prior to protocols receiving approval by the IRB, except for industry and cooperative group studies, which may be submitted concurrently on the condition that these studies must not be activated unless PRC approval is granted.

Annual progress reports

All studies to which NCI Data Table 4 applies are required to submit an annual progress report to the PRC if the study was approved by the IRB and activation took place at least six months ago.

The PRC coordinator will contact study teams at the appropriate time with annual review information.

Note: Suspended studies are not exempt from submitting an annual report.

Investigators who are not sure what type of review their study first received or whether an annual progress submission is required should email the PRC coordinator at PSCI-PRC@pennstatehealth.psu.edu.

This searchable directory provides a quick reference to the many tools, forms and resources described elsewhere on this page.

Meeting schedule and process

The Protocol Review Committee meets on the second and fourth Tuesday of each month.

In order for a PRC meeting to convene, there must be a quorum – a number of voting committee members in attendance equal to at least half the number of full members on the committee. In addition, at least one of the chairs and at least one statistical reviewer must be in attendance to constitute a quorum.

Investigators are invited to the meeting to answer any questions from the committee, and the group encourages investigators to attend or send a study representative.

Deadlines

Studies will not be reviewed until all paperwork is submitted.

Documents are due 10 days before the relevant PRC meeting to allow sufficient time for review. Exempt and expedited studies will be reviewed as soon as documents are received. See details on exempt, expedited and full reviews here.

New interventional or therapeutic study reviewed by Disease Team
Study undergoes feasibility review
Study submission to Clinical Trials Office
Study submission to PRC
 
PRC completes full review for interventional, therapeutic and non-therapeutic non-peer-reviewed studies (see full review details)

Industry studies may be submitted for concurrent IRB review at this time

or
PRC completes expedited review for NCI/cooperative group and CTEP studies (see expedited review details)

All such studies may be submitted for concurrent IRB review at this time


PRC approves study
Study submission to IRB
IRB approval received
Study activated
PRC conducts continuous review of the study
 
For interventional studies, if Penn State Cancer Institute is the DSMC of record:

DSMC conducts continuous review of interventional studies

or
For interventional studies, if Penn State Cancer Institute is not the DSMC of record:

DSMC of record conducts continuous review of interventional studies

New studies

All oncology-related studies, with no exceptions, must be submitted to PRC for review and approval before IRB submission.

Email PSCI-PRC@pennstatehealth.psu.edu for this form

Amendments

Protocol amendments that affect the principal elements of the original protocol – including but not limited to: study rationale, response criteria, eligibility criteria, objectives, study design, treatment plan, sample size, stopping rules or statistical plan – must be submitted to PRC for review and approval.

With questions about changes in an amendment that are not listed among these aspects, email the PRC coordinator at PSCI-PRC@pennstatehealth.psu.edu.

Note: Amendment submission is not required for NCTN studies and studies sponsored by other NCI-designated (or comprehensive) cancer centers with Penn State Cancer Institute as a participating site.

Complete the amendment submission form here

Retrospective Studies (Chart Review)

A retrospective study looks backward and examines exposures to suspected risk or protection factors in relation to an outcome that is established at the start of the study.

Retrospective studies can include analysis of existing samples from the Institute of Personalized Medicine biorepository or retrospective chart review.

Retrospective studies require a short PRC submission form.

Complete the retrospective study form here

Meet the team

  • General Inquiries

    With general questions, call the PRC coordinator at 717-531-0003, ext. 285237, or email PSCI-PRC@pennstatehealth.psu.edu.

    Caitlin Garrison
    Protocol Review & Monitoring Coordinator
    Penn State Cancer Institute
    Clinical Trials Office
    T2200/MC CH56
    500 University Drive
    Hershey, PA 17033

    Phone: 717-531-0003, Ext. 285237
    Fax: 717-531-1649
    Email: cgarrison2@pennstatehealth.psu.edu

    Committee Composition

    Voting members of the PRC are appointed by the Penn State Cancer Institute director.

    The voting members of the PRC are to represent the following disciplines:

    • Clinical/medical oncology/hematology
    • Pediatric hematology/oncology
    • Surgical oncology
    • Radiation oncology
    • Radiology
    • Pharmacy
    • Pharmacology and medicine
    • Basic laboratory science
    • Population science
    • Biostatistics
    • Pathology
    • Public health sciences ‐ statistician

    Leadership

    Voting Members

  • With general questions, call the PRC coordinator at 717-531-0003, ext. 285237, or email PSCI-PRC@pennstatehealth.psu.edu.

General Inquiries

With general questions, call the PRC coordinator at 717-531-0003, ext. 285237, or email PSCI-PRC@pennstatehealth.psu.edu.

Caitlin Garrison
Protocol Review & Monitoring Coordinator
Penn State Cancer Institute
Clinical Trials Office
T2200/MC CH56
500 University Drive
Hershey, PA 17033

Phone: 717-531-0003, Ext. 285237
Fax: 717-531-1649
Email: cgarrison2@pennstatehealth.psu.edu

Committee Composition

Voting members of the PRC are appointed by the Penn State Cancer Institute director.

The voting members of the PRC are to represent the following disciplines:

  • Clinical/medical oncology/hematology
  • Pediatric hematology/oncology
  • Surgical oncology
  • Radiation oncology
  • Radiology
  • Pharmacy
  • Pharmacology and medicine
  • Basic laboratory science
  • Population science
  • Biostatistics
  • Pathology
  • Public health sciences ‐ statistician

Leadership

Voting Members

With general questions, call the PRC coordinator at 717-531-0003, ext. 285237, or email PSCI-PRC@pennstatehealth.psu.edu.