Drug Accountability. Accountability for the study medication at the study site is the responsibility of the Investigator. Drug accountability will be performed only on alendronate, calcium and vitamin D. The Investigator will ensure that the study medication is used only in accordance with this protocol. Where allowed, the Investigator may choose to assign some of the study medication accountability responsibilities to qualified study personnel. Study medication accountability records indicating the delivery date to the study site, inventory at the study site and dispensing/use will be maintained. These records will adequately document that the study medications were dispensed and returned as specified in the protocol. Accountability records will include dates, quantities, and subject numbers. The Sponsor (or its designee) will review study medication accountability records at the study site on an ongoing basis during the study. All used and unused study medication must be inventoried, accounted for, and approved by the Sponsor (or its designee) prior to destruction. If the site is not capable of study drug disposal/destruction, the Sponsor will arrange for an alternative method. Records of disposal must be maintained with the study records.
Drug Accountability. Forms will be provided to track drug accountability and administration throughout the study. Drug accountability will be reviewed during routine monitoring visits.
Drug Accountability. The clinical investigator is responsible for ensuring that all study drug received at the site is inventoried and accounted for throughout the study. The dispensing of study drug to the subject, and the return of study drug from the subject (if applicable), must be documented on the drug accountability form. Contents of the study drug containers must not be combined. Study drug must be handled strictly in accordance with the protocol and the container label and will be stored in a limited access area or in a locked cabinet under appropriate environmental conditions. Unused study drug, and study drug returned by the subject (if applicable), must be available for verification by the sponsor’s or designee’s site monitor during on-site monitoring visits. The return to the sponsor of unused study drug, or used returned study drug for destruction, will be documented on the Drug Return Form. Procedures for final disposition of unused study drug (e.g., return to the sponsor, third-party contractor, or designee, or destruction at the site) may vary from region to region. Please refer to the Study Reference Manual (Accountability) for specific guidance. Study drug should be dispensed under the supervision of the investigator, a qualified member of the investigational staff, or by a hospital/clinic pharmacist. Study drug will be supplied only to subjects participating in the study. Returned study drug must not be dispensed again, even to the same subject. Study drug may not be relabeled or reassigned for use by other subjects. The investigator agrees neither to dispense the study drug from, nor store it at, any site other than the study sites agreed upon with the sponsor.
Drug Accountability. The Investigator is responsible for the accountability of all used and unused study drug. Drug accountability records must be kept current. These records should contain the dates, quantities and identification numbers (or lot numbers) of study drug received by the Investigator, dispensed or administered to specified subjects, returned from subjects (if applicable), disposed of at the site.
