The following will be observed for compliance with Food and Drug Administration 
regulations involving the conduct and monitoring of clinical investigations; they also 
represent sound research practice: 
11.1 Institutional Review 
This study will be approved by an appropriate institutional review committee as 
defined by Federal Regulatory Guidelines (Ref. Federal Register Vol. 46, No. 17, January 27, 
1981, part 56). The protocol and informed consent form for this study will be approved in 
writing by the appropriate Institutional Review Board (IRB). The IRB will be from an institution 
which has a valid Multiple Project Assurance, Single Project Assurance or Cooperative 
Oncology Group Assurance on file with the Office for Protection from Research Risks, 
National Institutes of Health. The institution must be in compliance with regulations of the 
Food and Drug Administration and the Department of Health and Human Services. 
Significant changes to the protocol, as well as a change of principal investigator, will 
also be approved by the Board and documentation of this approval provided to the study 
monitor. Records of the Institutional Review Board review and approval of all documents 
pertaining to this study will be kept on file by the investigator and are subject to FDA 
inspection at any time during the study. Periodic status reports will be submitted to the 
Institutional Review Board at least yearly, as well as notification of completion of the study 
and a final report within 3 months of study completion or termination. The investigator will 
maintain an accurate and complete record of all submissions made to the Institutional Review 
Board, including a list of all reports and documents submitted. 
11.2 Drug Accountability 
For each drug supplied for this study an accountability ledger containing current and 
accurate inventory records covering receipt, dispensing, and the return of study drug supplies 
will be maintained. The ledger will be maintained routinely for all studies regardless of study 
design, and will identify for each shipment the subject number (as applicable) and the 
quantity of drugs contained in the shipment. The ledger will consist of drug Accountability 
Record Forms supplied by the NCI. One form for each investigational drug used on each 
research protocol will be kept. A separate drug Accountability Form will also be maintained 
for each different strength or dosage form of the particular drug being used. 
Drug supplies will be kept in a secure, limited access storage area under the 
recommended storage conditions. During the course of the study, the following information 
will be noted on the accountability ledger; the identification code of the subject to whom drug 
is dispensed, the date(s) and quantity of drug dispensed to the subject, and the date(s) and 
quantity of drug returned by the subject; subjects should return empty containers to the 
investigator, and the return noted on the ledger. These Accountability Forms will be readily 
available for inspection and are open to FDA inspection at any time. 
11.3 FlepQIlinfl.■!!A DR ,, (A dv erse DrugReactionsKNCI 12/ 89 .) 
The Federal (NCI and FDA) guidelines and conditions under which an "ADR" should 
be reported are given in Appendix K. The appropriate forms will be completed and submitted 
to both the NCI and to the University IRB Committee. This reporting will be performed 
according to the guidelines listed below. 
1 1.4 University of Michigan Cancer Center Reporting Requirements of "ADR" 
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Recombinant DNA Research, Volume 18 
