GC: n
S: http://researchcompliance.uc.edu/Libraries/Human_Subjects_Research_IRB_Documents/9_Drug_Accountability_in_Human_Research_Studies.sflb.ashx (last access: 6 March 2013); http://www.cenduit.com/drug-accountability (last access: 3 September 2014).
N: Drug accountability includes: study drug storage, handling, dispensing, and documentation of administration, return and/or destruction of the drug.
A drug accountability process should be initiated for any study that uses study-supplied drug. Study drug can be an investigational agent or an approved drug that is being tested for a currently unapproved use. When testing investigational drugs, clinical trial sponsors and investigators must follow the rules of conduct established by the US Food Drug Administration (FDA) and Cuban Regulatory Agency (Center for Drug Quality Control, CECMED). These rules describe sponsor and investigator responsibilities, recordkeeping and record retention, inspection of records and reports, control of the investigational drug, disposition of unused drug, assurance of Institutional Review Board (IRB) review, handling of controlled substances, and reasons for disqualifying a clinical investigator.
S: http://www.bvs.sld.cu/revistas/far/vol45_4_11/far15411.htm (last access: 1 October 2015)
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