UPMC CLINICAL TRIALS OFFICE

Submission Requirements

In order to adhere to the terms of the agreement between the University of Pittsburgh and UPMC establishing the UPMC Clinical Trials Office, all submissions received by the UPMC CTO after June 1, 2006 must list an accredited IRB as the IRB of record (see Appendix A of the UPMC CTO Background Information document for a current listing of accredited central IRBs).

Beginning September 11, 2006, all submissions received by the UPMC CTO must use the updated forms (dated 08/29/06)


Reminders to Facilitate Processing:

• Please include the CTO number for your project on all correspondence submitted to the UPMC CTO. For e-mails, please include the CTO number in the subject line.
• Please verify that all required documents are included in the submission e-mail and that all forms are completely filled out. Incomplete submissions cannot be processed.
• The Principal Investigator Agreement (last page of the UPMC CTO application form) lists the various documents that must be submitted to the UPMC CTO on an on-going basis. It is critically important for these documents to be submitted in a timely fashion. A continuing oversight form must accompany the submission of continuing oversight paperwork to the UPMC CTO. Submissions of continuing oversight paperwork should be sent to the UPMC CTO mailbox (clinicaltrialsoffice@upmc.edu).

If electronic versions of the sponsor’s protocol or Investigator’s Brochure are not available, please deliver a hard copy to Suite 219, Murdoch Building, 3434 Forbes Avenue.

1. 1 Copy: Completed UPMC Clinical Trials Office Application Form
2. 1 Copy: Sponsor's Drug Information (Investigator's Brochure) or Device Information Packet (e.g. description of device, reimbursement information, etc.)
3. 1 Copy: Sponsor's Clinical Protocol
4. 1 Copy: IRB Approved or Proposed Informed Consent Document*
5. 1 Copy: HIPAA Authorization Addendum (if the IRB approved or proposed informed consent document does not include HIPAA language)
6. 1 Copy: Proposed Sponsor Clinical Trial Agreement (as a Word Document)
7. 1 Copy: Completed UPMC Clinical Trial Fiscal Review Form
8. 1 Copy: Completed (Researcher's Section) UPMC Fiscal Approval Form
9. 1 Copy: Sponsor's Draft Clinical Trial Budget

   * IRB approval (external or University of Pittsburgh) may be obtained concurrently with UPMC Clinical Trials Office processing. For such clinical trials, please include the proposed informed consent document (i.e., the version submitted to the IRB).

In order to receive final UPMC Clinical Trials Office approval to conduct an applicable industry-initiated and sponsored clinical trial within the UPMC environment (i.e., in order to execute final signing of the sponsor's clinical trial agreement by the UPMC Clinical Trials Office); the following additional materials will need to be submitted to the UPMC Clinical Trials Office.

• 1 Copy: Written Notification of IRB Approval to Conduct the Clinical Trial at this (i.e., UPMC or UPP) Site*
• 1 Copy: Final IRB Approved Informed Consent Document for the UPMC Site
• 1 Copy: Written Notification of UPMC Clinical Department Risk-Management Approval to Conduct the Clinical Trial at this Site
• 1 Copy: Final Negotiated Version of the Clinical Trial Budget