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Important Forms and Templates

by Ellen de Graffenreid — last modified Aug 22, 2011 02:38 PM

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:

Please note, Lineberger Protocol Templates can now be found at the Template page here.

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

Prioritization Checklist Icon indicating that a link will open a Microsoft Excel file.

PRC Submission Cover SheetAn icon indicating that a link will open a Microsoft Word document.

Biostatistician Sign-Off SheetAn icon indicating that a link will open a Microsoft Word document.

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

PRC Submission Cover SheetAn icon indicating that a link will open a Microsoft Word document.

DSMP TemplateAn icon indicating that a link will open a Microsoft Word document.

Biostatistician Sign-Off Sheet An icon indicating that a link will open a Microsoft Word document.(For Lineberger Investigator Initiated studies)

For IRB application information, see the IRB websiteIcon indicating that a link will open an external site.. If you know which forms you need to submit for the IRB, you can find them on the IRB Forms websiteIcon indicating that a link will open an external site..

For All New Studies Requesting CPO Services:

PRC Submission Cover SheetAn icon indicating that a link will open a Microsoft Word document.

Consent FormAn icon indicating that a link will open a Microsoft Word document.

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

For IRB application information, see the IRB websiteIcon indicating that a link will open an external site.. If you know which forms you need to submit for the IRB, you can find them on the IRB Forms websiteIcon indicating that a link will open an external site..

DSMC REPORT FORMS

EVALUATION FORMS BY RISK:

DSMC REPORT MINIMAL RISKAn icon indicating that a link will open a Microsoft Word document.

DSMC REPORT MODERATE RISKAn icon indicating that a link will open a Microsoft Word document.

DSMC REPORT HIGH RISK PHASE IAn icon indicating that a link will open a Microsoft Word document.

DSMC REPORT HIGH RISK PHASE I-II OR IIAn icon indicating that a link will open a Microsoft Word document.

DSMC REPORT HIGH RISK PHASE IIIAn icon indicating that a link will open a Microsoft Word document.