I. Basic Protocol Information

Protocol ID (include as many as are known):

Protocol Title:

Name and Address of organization submitting protocol:

Current Status (active, approved, other):

Status Date (date of activation, approval, other):

II. Protocol Sponsorship and Review Information
Please choose the appropriate funding/review sources:

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NCI Grant
    Grant Number:
    Grant Principal Investigator:

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NCI Cancer Center Protocol Review and Monitoring System (please provide signed confirmation of the approval from the chairperson of the PRMS committee)

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NCI Cancer Therapy Evaluation Program (CTEP) Review

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NCI Division of Cancer Prevention (DCP) Review

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Pharmaceutical Industry Sponsored
    Industry Sponsor Name:

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Sponsored by Submitting Organization

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None of the Above

III. Contact Information

Study Chairperson name:

Chairperson address:

Chairperson telephone:

Chairperson fax:

Chairperson electronic mail:

Please provide the name of a person at your organization who will respond to periodic requests for update information:

Update person name:

Update person title:

Update person address:

Update person telephone:

Update person fax:

Update person electronic mail:

Additional Key Investigators and Institutions
Other institutions and their associated investigators conducting this study (if more practical, attach a list in lieu of filling out the following information):

Organization name and address:

Investigator name:

Investigator address:

Investigator phone

Investigator fax:

Investigator electronic mail:

IV. Please include each of the following items with this completed form if applicable:

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Copy of the protocol with complete statistical section. The protocol may be submitted as a Word or WordPerfect file via e- mail or on an IBM-formatted diskette, or as legible, paginated hard copy document

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A list of all participating organizations and the associated investigators who should appear in PDQ as contacts for the study

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A copy of IRB approval and an IRB-approved informed consent from one of the study sites (all of the study sites should have an IRB-approved consent form, but you only need include a copy of one)

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Confirmation of approval from chairperson of Protocol Review and Monitoring Committee (for NCI designated clinical and comprehensive cancer center trials only)

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A completed and signed copy of the PDQ Protocol Notification Agreement (for Phase II & III trials)

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

Protocol documents and other related materials may be sent as a Word or WordPerfect file via electronic protsub@cips.nci.nih.gov.

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