1 / *Complete the following table for all investigational agents (drugs or biologics that have not been approved by the FDA, or proposed uses of FDA approved drugs not yet approved by the FDA) to be administered to participants in this research:
Investigational Drug Name / Manufacturer / IND Holder
(Sponsor) / FDA Issued If the IND number is not listed
IND Number in the protocol, then attach
documentation from the Sponsor
that verifies the IND number.
[View] / Drug X / EMD / EMD Serono / 64,216
2 / Will hospital pharmacy services be used to store and dispense investigational drugs in accordance with Administrative Policy MM.06.01.05, Investigational Drug Studies?
[c1]Yes No
If Pharmacy Services will not be used, please explain :
3 / Please indicate all locations where study drug will be administered or given to subjects.
/ CSMC inpatient area
/ CSMC outpatient area
/ CancerCenter
/ GCRC
/ Thalians
/ CSMC procedure center or physician's office
/ Private office or center of CSMC-affiliated physician
4 / *Will the study drugs or biologics be manufactured in whole or in part at a CSMC facility or under the supervision of CSMC investigators?
Yes No
Describe the standard operating procedures (SOPs) for the manufacture of study drugs or biologics. Your response should include a description of:
- Materials involved;
- Facilities and equipment to be used;
- Processes to ensure product quality, purity, and sterility;
- Quality control and assurance mechanisms;
- Delegation of responsibilities; and
- Training to be completed with individuals involved in the manufacture of study drugs or biologics.
5 / *Does this protocol involve gene therapy or gene transfer?
[c2]Yes No
Gene transfer researchrequired review beside the IRB:
Type of Review / Review Status / Upload Review or Approval Document
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6 / Please upload your investigational drug brochure (s) here. If you have scanned the brochure in separate parts, please label each section, i.e., Part I, Part II, etc.
name / version
Investigator's Brochure V12 / 0.02
7 / Please upload your SIGNED FDA Form 1572 here[c3]:
MAY 2010 1572(0.01)
If the “Study Identification” page indicates that this is an investigator-initiated study, then this will activate the following question:
Will the CSMC investigator be the IND holder?
Yes No
Hide/Show –If YES: If the study is investigator-initiated and the CSMC investigator will be the IND holder, aAttach copies of all IND applicationsand correspondence with the FDA regarding the IND:
name / version
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[c1]
Current text: Please refer to the Department of Pharmacy Services policy, Investigational Drug Studies, for additional detail regarding requirements related to the storage, labeling, dispensing and management of investigational drugs, as well as policies related to the administration of investigational drugs.
[c2]
Current text: Gene therapy or gene transfer refers to the transfer of material from recombinant DNA into a human subject. There are many added regulatory requirements for human gene transfer research
[c3]
NEW HELP TEXT:
Note that the names of the sub-investigators on the FDA 1572 Form should be consistent with the co-investigators listed in the study application.