To submit your protocol electronically using the online Protocol Submission Form, the protocol must have been reviewed by one of the following review processes.

1. Clinical trials conducted at NCI-designated clinical and comprehensive cancer centers that have a Protocol Review and Monitoring System (PRMS) approved under the auspices of the NCI's Cancer Centers Program.

2. Clinical trials conducted directly under peer-reviewed NCI grant support where the clinical trial protocol was reviewed as part of the grant application.

3. Phase II and III clinical trials submitted to the Food and Drug Administration (FDA) under the Investigational New Drug (IND) regulations. If you are submitting your study under the FDA's IND regulations, you must complete, sign, and fax the PDQ Protocol Notification Agreement to the PDQ Protocol Coordinator at 301-480-8105.

Below is a list of fields and the type of information that is needed to process your protocol for inclusion in PDQ. Please be as thorough as possible when completing the form so that your study's abstract is as accurate as possible. After you have read this page, you may click on the button at the end of this page to access the protocol submission form to be completed and submitted to NCI.

Title
Protocol I.D.	Please include as many as are known
Rationale	A brief explanation of why the study is being completed
Protocol Objectives	Goals of the study
Outline	A brief description of the treatment plan. This should include the drugs or therapy the patient will receive and at what times
Protocol Entry Criteria/Patient Eligibility	The disease characteristics that a person must have to be enrolled in this trial
Prior/Concurrent Therapy	Any therapies that would exclude a person from this trial
Patient Characteristics/ Inclusion Criteria	Age, sex, performance status, etc.
Projected Accrual	The number of patients expected to be entered on the trial before it closes to accrual
Study Activation Date	The date when patients are allowed to be entered on the trial
Name and complete address information for the protocol chairperson
Name and complete address information for the protocol update person

Additional Information

Please fax or send hard copy documents of all of the participating institutions and their associated investigators conducting this study to the address below. Also, include a copy of an IRB approval and IRB-approved patient consent form from one of the participating institutions. All of the study sites should have IRB approval and a consent form, but you only need to send a copy from one of the sites.

Please send hard copy documents to:

PDQ Protocol Coordinator
Attn: CIAT
Cancer Information Products and Systems, NCI, NIH
6116 Executive Blvd. Suite 3002B MSC-8321
Bethesda, MD 20892-8321

Documents of no more than 10 pages may be faxed to the PDQ Protocol Coordinator at 301-480-8105.

Please clearly identify the protocol by number when faxing related materials.

If you have any questions about submitting your protocol to PDQ, please contact the PDQ protocol coordinator at 301-496-7406 or email: protsub@cips.nci.nih.gov.

PDQ Protocol Submission Form
PDQ Protocol Submission Checklist

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