/ OHSU Knight Cancer Institute
Standard Operating Procedures (SOP)
Clinical Trial Registration on National Cancer Institutes’ PDQ / SOP Approval Date: 08/01/2005
SOP Revision #
SOP Contact: Margaret McMahon
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The OHSU Knight Cancer Institute is now requiring that all principal investigators (PI) conducting cancer-related, investigator initiated, interventional, clinical research studies to list their studies through the National Cancer Institute’s PDQ online database.

This requirement does NOT apply to cooperative group studies, industry written studies, or studies that are investigator initiated at another medical institution where OHSU is a study site but not the lead investigator.

The International Committee of Medical Journal Editors (ICMJE) has recently recommended that sponsors of interventional clinical trials list their studies with a clinical trial registry that is accessible to the public and free of charge. The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. The ICMJE does not advocate one particular registry but suggested that sponsors list with clinicaltrials.gov or a similar public registry. For more information on the ICMJE publication requirements go to:

The National Cancer Institute (NCI) has a clinical trials registry database called Physician Data Query (PDQ) that meets the ICMJE requirements. Clinicaltrials.gov and NCI’s PDQ are both under the control of the NIH, and they cross list studies. Since OHSU is an NCI designated cancer center the review process to list through NCI’s PDQ is easier and faster than with NIH’s clinicaltrials.gov. General Information about PDQ may be found in this NCI fact sheet:

This SOP applies to all studies that are currently open to participant accrual or those studies that will open to accural after July 1, 2005. All studies, meeting the above criteria, should be listed on PDQ no later than September 1, 2005.

Clinical Research Review Committee (CRRC) approval memo {PDQ refers to this as Protocol Review Monitoring System (PRMS) approval}

IRB Initial Study Approval Memo {The Memo that is sent after both the protocol and consent are approved and IRB gives the PI permission to start the study}

PDQ submission checklist - this can be completed online at:

**OHSU IRB approval of the PDQ submission text is NOT REQUIRED. The OHSU IRB Compliance Manager, Charlotte Shupert and IRB Co-Chairpersons Gary Chiodo and Maggie Allee stated in an email communication with CRM (dated 5/18/05) that submitting a protocol summary to the NCI PDQ database does not require review or prior approval from the OHSU IRB. They stated that submitting basic facts about a study for inclusion in the NCI online database does not require an “advertisement” IRB review.

Investigators wishing to submit an advertisement to another website though should follow the OHSU IRB policy for review and prior approval of the text.

OHSU IRB Policies (see Advertisement Policy)

  1. Fill out the PDQ online submission form and submit via the PDQ website
  2. Once you have completed the online submission: FAX, email, or mail the CRRC and IRB approval memo to PDQ at:

FAX: 301-480-8105

OR

Email:

OR

PDQ Protocol Coordinator

Attn: CIAT

Cancer Information Products And Systems, NCI, NIH

6116 Executive Blvd., Suite 3002B MSC-8321

Bethesda, MD 20892-8321

If you prefer not to use the online submission form you may also submit all of these documents via FAX or U.S. Mail with a typed copy of the protocol summary facts.

This registration procedure should be completed within 10 working days after receiving Initial IRB approval for a new study.