Clinical and Translational Research Center: Submission Guidelines

Protocols are reviewed bi-weekly by the Clinical and Translational Research Center (CTRC) Advisory Committee. Studies are scored on scientific merit and the need for the CTRC. Studies may be initiated once CTRC Advisory Committee and IRB approval have been obtained. The residents and the principal investigator of the study in which the patient is enrolled provide emergency coverage of patients seen in the CTRC.

As a requirement of our funding agency, the CTRC Advisory Committee performs scientific review for all protocols requesting use of the CTRC.

As per MWRI policy, the CTRC Advisory Committee also provides scientific review for all non-CTRC protocols excluding oncology research.

An approval letter from the appropriate committee must accompany the protocol application to the IRB.

Please submit your application electronically in one single file to:
Patricia Barcic
mwhctrc@mail.magee.edu
Magee-Womens Hospital, Room 4327
300 Halket Street
Pittsburgh, PA 15213
412-641-5349

OSIRIS submissions are acceptable. If you are not using OSIRIS, please follow the guidelines below.

Please be sure to include the following documents in your electronic application (as one PDF file) in the following order:

  1. University of Pittsburgh IRB Coversheet
  2. Protocol – A) Protocols requesting use of the CTRC must utilize the CTRC format; B) Protocols not requesting use of the CTRC must utilize the Pitt IRB format
  3. Consent Form
  4. CTRC Submission form

Please send one electronic copy of the following as applicable:

  • Industry Protocol (if industry sponsored)
  • Industry Brochure (if industry sponsored)
  • Industry Correspondence (if industry sponsored)
  • Master protocol (Grant protocol)

Proposal Format

DSMP

DSMB Requirement Memorandum

NIH-Defined Clinical Research and Clinical Trials