CLINICAL TRIAL SOURCE
US & CANADIAN |
REVIEW FOR INCLUSION IN PDQ |
HOW AND WHAT TO SUBMIT |
| NCI's Cancer Therapy Evaluation Program (CTEP) |
No Additional Review Required |
Protocols will be automatically submitted to us by CTEP. You do not need to
submit these protocols to us again.
|
| NCI's Center for Cancer Research (CCR) |
No Additional Review Required |
Protocols will be automatically submitted to us by CCR. You do not need to
submit these protocols to us again.
|
| NCI's CTEP-Cooperative
Groups
|
No Additional Review Required |
Protocols will be automatically submitted to us by CTEP. You do not need to
submit these protocols to us again.
|
| NCI's Division of Cancer Prevention (DCP)
|
No Additional Review Required |
Protocols will be automatically submitted to us by DCP. You do not need to
submit these protocols to us again.
|
| NCI-designated
clinical & comprehensive cancer centers that have a Protocol Review
Monitoring System (PRMS) |
No Additional Review Required |
Submitter must send a copy of PRMS approval along with a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette). It may also be submitted
online or as an attachment via electronic
mail.
|
| NCI Sponsored Clinical Trials directly under peer-reviewed NCI grant support
(R01, P01, U01, or other NIH grants) |
No Additional Review Required |
Submitter must send a copy of a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette). It may also be submitted
online or as an attachment via electronic
mail.
|
| National Cancer Institute of Canada (NCIC) |
No Additional Review Required |
Submitter must send a copy of a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette). It may also be submitted
online or as an attachment via electronic
mail
|
| Pharmaceutical Industry sponsored Phase II & Phase III Clinical Trials
submitted to FDA under Investigational New
Drug (IND) regulations |
No Additional Review Required |
Submitter must send a completed and signed copy of the
PDQ Protocol Notification Agreement along with a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette). It may also be submitted
online or as an attachment via electronic
mail.
|
| All Medical Research Institutions conducting Phase II & Phase III Clinical
Trials submitted to FDA under Investigational
New Drug (IND) regulations |
No Additional Review Required |
Submitter must send a completed and signed copy of the
PDQ Protocol Notification Agreement along with a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette). It may also be submitted
online or as an attachment via electronic
mail.
|
| Other NIH-Sponsored Clinical Trials |
Trials will be reviewed by the PDQ Editorial Board for Voluntary Protocol
Review |
Submitter must send a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette) or as an attachment via
electronic mail.
|
| All Other Clinical Trials |
Trials will be reviewed by the PDQ Editorial Board for Voluntary Protocol
Review |
Submitter must send a completed
submission checklist to PDQ Coordinator via fax or mail.
Protocol document may be mailed as a paper document or as a Word or WordPerfect
file (on an IBM-formatted diskette) or as an attachment via
electronic mail.
|
Documents of no more than 10 pages (e.g., the IRB approval) may be faxed to the
PDQ Protocol Coordinator at: 301-480-8105
| CLINICAL TRIAL SOURCE
|
| EUROPEAN AND OTHER NON-US |
|
REVIEW FOR INCLUSION IN PDQ |
HOW AND WHAT TO SUBMIT |
|
European Organization for Research and Treatment of Cancer |
No Additional Review Required |
Protocols will be automatically submitted to us by EORTC
|
|
Cancer Research UK (former Cancer Research Campaign and Imperial Cancer
Research Fund) |
No Additional Review Required |
*Protocols should be submitted to the NCI Liaison Office. Submitter must send a
copy of a completed submission checklist (obtainable on request from the
Brussels office) to PDQ Coordinator, Brussels.
|
|
United Kingdom Medical Research Council |
No Additional Review Required |
*Protocols should be submitted to the NCI Liaison Office. Submitter must send a
copy of a completed submission checklist (obtainable on request from the
Brussels office) to PDQ Coordinator, Brussels.
|
|
United Kingdom Children's Cancer Study Group
|
No Additional Review Required |
*Protocols should be submitted to the NCI Liaison Office. Submitter must send a
copy of a completed submission checklist (obtainable on request from the
Brussels office) to PDQ Coordinator, Brussels.
|
|
Protocols with certificate of review from Deutsche Krebsgesellschaft(German Cancer Society) |
No Additional Review Required |
*Protocols should be submitted to the NCI Liaison Office, Brussels.
Submitter
must send a copy of a completed submission checklist (obtainable on request
from the Brussels office) to PDQ Coordinator, Brussels.
|
|
Münchner Studienzentrum der Klinikum rechts der Isar der Technischen
Universität München (Munich Clinical Study Group at Munich Technical
University) |
No Additional Review Required |
*Protocols should be submitted to the NCI Liaison Office, Brussels. Submitter
must send a copy of a completed submission checklist (obtainable on request
from the Brussels office) to PDQ Coordinator, Brussels.
|
European Groups not listed above, including
-
Federation Nationale des Centres de Lutte Contre le Cancer(FNCLCC) (National
Federation of Centers in the Fight Against Cancer)
-
Stichting Hemato-Oncologie Voor Volwassenen Nederland (HOVON) (Hemato-Oncology
Foundation for Adults in the Netherlands)
-
International Breast Cancer Study Group (IBCSG)
-
Irish Clinical Oncology Research Group (ICORG)
-
Dutch Cancer Society (KWF-CKVO)
-
Swiss Institute for Applied Cancer Research (SIAK)
-
Societe Internationale d'Oncologie Pédiatrique (SIOP)(International Society for
Pediatric Oncology)
|
Additional Review Required; Organized by the NCI Liaison Office, Brussels
|
*Protocols should be submitted to the NCI Liaison Office, Brussels. Submitter
must send a copy of a completed submission checklist (obtainable on request
from the Brussels office) to PDQ Coordinator, Brussels.
|
|
Other Non-US Trials |
Additional Review Required |
*Submitter must send a copy of a completed
submission checklist to PDQ Coordinator via fax or mail.
|
*Protocol document may be either mailed or sent via electronic mail.
Non-English language protocols should also be accompanied by a protocol
summary, preferably in English. See "Online
PDQ Protocol Submission Instructions" for guidelines on what should be
included in the summary.
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