Oncology Protocol Review Committee

IMPORTANT FORMS AND TEMPLATES

If you don't know which forms you need to submit to the PRC, visit the Instructions for Submitting Clinical Trial Materials to the PRC site. If you know which forms you need to submit to the PRC, you can find them below:

For LCCC Studies Requesting Clinical Protocol Office (CPO) Services :

Letter of Intent

Lineberger Protocol Template

PRC Submission Cover Sheet

Biostatistician Sign-Off Sheet

For All NEW Studies not Requesting Clinical Protocol Office Services (Non-CPO):

Letter of Intent (For LCCC Investigator Inititiated studies)

PRC Submission Cover Sheet

Lineberger Protocol Template

DSMP Template

Correlative Science Template

Biostatistician Sign-Off Sheet (For Lineberger Investigator Initiated studies)

For IRB application information, see the IRB website. If you know which forms you need to submit for the IRB, you can find them on the IRB Forms website.

For All New Studies Requesting CPO Services:

PRC Submission Cover Sheet

Consent Form

Progress Report under Renewal or Termination of IRB Approval of Human Subjects Research on IRB webpage

For IRB application information, see the IRB website. If you know which forms you need to submit for the IRB, you can find them on the IRB Forms website.

DSMC REPORT FORMS

EVALUATION FORMS BY RISK:

DSMC REPORT MINIMAL RISK

DSMC REPORT MODERATE RISK

DSMC REPORT HIGH RISK PHASE I

DSMC REPORT HIGH RISK PHASE I-II OR II

DSMC REPORT HIGH RISK PHASE III