Drug Accountability Log Template. The drug accountability should provide a comprehensive list of all study product dispositions on the site level. Complete the log as study product is dispensed and/or received, to ensure completeness and accuracy of the data.
Drug dispensation & accountability log. Includes the following information (as seen in out templates) date received return of unused drug or device. Bottle #/box #/ kit # (choose as appropriate) date dispensed.
Subject Who Received Drug Or Device Recorder’s Initials
This template allows the principal investigator and study team to fulfill their responsibilities regarding device accountability record maintenance for significant risk devices. Number each page and store pages in reverse chronological order, with the newest pages of the log placed at the front of the section. For blinded clinical studies, it is recommended that study product accountability records be filed in a separate location (e.g., the research pharmacy), to maintain the blind.
Nimh Version 1.0 July 2019Page 2 Of 3.
Pi name, protocol or irb number, and/or protocol short title. Biological materials might be sent to the local laboratory or to a central laboratory. Nimh subject specific investigational product dispensation and accountability log template version 1.0.
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The amount of drug left. When applicable, this standard operating procedure (sop) describes the processes at this. Drug dispensation accountability log (per subject) updated 11/22/2019.
Complete The Log As Study Product Is Dispensed And/Or Received, To Ensure Completeness And Accuracy Of The Data.
Pages of the log placed at the front of the section. Your records may require additional information, depending on the type of trial and type of drug. Include the particular date and place your electronic signature.
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Dispensed to subject returned by subject compliance lot number(s) randomization number number of containers dispensed number of units dispensed date dispensed dispensed by (staff initials) expected date of first dose number of containers returned number of units returned date returned verified by. Adobe acrobat (.pdf) ms word (.doc) excel (.xls) letter of intent (loi) submission form. Customize the template with unique fillable areas.