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1
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2
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- Pharmaceutical Companies
- NCI
- Commercially available products
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3
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- Procedure varies by study.
- Detailed instructions for obtaining drug can be found in Section 7.0 of
the protocol
- First step usually requires faxing the Study Agent Shipment Form (SASF)
to CTSU (US) or RTOG (Canada).
- RTOG Processing of this form approves the site as eligible to receive
drug
- Registration/Randomization is generally the trigger for the initial
shipment
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4
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5
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6
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- Realistic Treatment Start Dates
- If the SASF has already been processed, drug is generally shipped for
overnight or two day delivery.
- Most distributors will not ship prior to a weekend or holiday.
- Shipments are limited between December 23 and January 1.
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7
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- Submitting your SASF for processing as soon as the individual
responsible for the drug at your institution has been identified will
assist you in:
- avoiding delays in the initial drug shipment
- alleviating frustration and inconvenience for yourself and most
importantly the patient
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8
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- NCI sponsored studies
- The Pharmaceutical Management Branch (PMB) of the NCI is responsible
for supplying study agent for NCI trials.
- NIH Form 986/Clinical Drug Request is used to order study drug for NCI
sponsored trials
- All NCI Forms are available on the NCI website at http://ctep.cancer.gov/requisition/storage.html
- Clinical Drug Request
- Investigational Agent Accountability Record
- Drug Return
- Drug Transfer
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9
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- Investigators must be registered with the
- NCI and have an Investigator NCI Number to
- receive drug from the NCI.
- This requires the annual submission of:
- FDA 1572 with CVs
- signed Supplemental Investigator Data Form (IDF)
- Financial Disclosure Form
- NCI/PMB Contact Information:
- Phone: (301) 496-5725
- Fax: (301) 402-0429
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10
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11
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- Supplied free of charge through pharmaceutical support
- Obtained via prescription from the physician
- Usually covered by patient’s prescription plan
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12
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- NCI
- ACR/RTOG
- Pharmaceutical Companies
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13
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- Varies by sponsor/protocol
- Records of accountability documentation
- Receipt of Drug
- Dispensation of Drug
- Disposition of Drug (returned/destroyed used/unused)
- Instructions usually documented in the protocol
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