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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