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This document serves as a record for tracking the accountability of investigational products in clinical trials, documenting receipt, dispensing, balance, and returns.
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How to fill out master investigational product accountability log

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How to fill out master investigational product accountability log

01
Start with the title and date on the log.
02
List the name of the investigational product.
03
Include the protocol number associated with the study.
04
Record the subject ID or number for each participant.
05
Document the quantity of the investigational product received.
06
Note the date the product was dispensed to the participant.
07
Record the return date if any product is returned.
08
Log the quantity of the investigational product remaining after each use.
09
Include the signature of the person dispensing and receiving the product.
10
Review entries regularly for accuracy and completeness.

Who needs master investigational product accountability log?

01
Clinical trial coordinators
02
Investigators conducting the study
03
Pharmacy staff managing investigational products
04
Regulatory bodies for compliance purposes
05
Study monitors or auditors verifying trial data

What is master investigational product accountability log - academic-medicine edu Form?

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The master investigational product accountability log is a document that tracks the receipt, usage, and disposition of investigational medicinal products during a clinical trial. It serves as a comprehensive record to ensure proper handling and compliance.
The master investigational product accountability log is typically required to be filed by clinical trial investigators, study coordinators, and other personnel involved in the management of investigational products within a clinical research organization.
To fill out the master investigational product accountability log, one should record details such as the product name, batch number, quantity received, dates of receipt and usage, inventory counts, and any discrepancies or losses. Each entry should be made clearly and accurately to maintain accountability.
The purpose of the master investigational product accountability log is to ensure accountability, traceability, and compliance with regulatory requirements for the management of investigational products. It helps to safeguard participant safety and integrity of clinical trial data.
Information that must be reported includes the product identification details (name and batch number), quantities received, dates of receipt and usage, inventory levels, dispensation records to subjects, returned or destroyed products, and any discrepancies noted during the trial.
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