- 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)
- ___
-
NCI Cancer Therapy Evaluation Program (CTEP) Review
- ___
-
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
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Study Chairperson name:
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Chairperson address:
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Chairperson telephone:
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Chairperson fax:
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Chairperson electronic mail:
Please provide the name of a person at your organization who will respond to
periodic requests for update information:
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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):
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Organization name and address:
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Investigator name:
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Investigator address:
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Investigator phone
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Investigator fax:
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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)
Additional Information
If sending hard copy documents, send 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 (e.g., the IRB approval) may be faxed to the
PDQ Protocol Coordinator at: 301-480-8105
PLEASE clearly identify the protocol by number when faxing related materials.
Protocol documents and other related materials may be sent as a Word or
WordPerfect file via electronic protsub@cips.nci.nih.gov.
PLEASE include the protocol number in the subject line of the message when
sending materials by electronic mail.
QUESTIONS? Call the PDQ Protocol Coordinator at 301-496-7406.
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