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. Cancer 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
Office of Cancer Content Management, NCI, NIH
6116 Executive Blvd. Suite 3002B MSC-8321
Bethesda, MD 20892-8321
Documents of no more than 20 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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