Get the free investigational product accountability record (form g) - research rutgers

PAGE NO. Investigational Agent Accountability Record Name of Institution:Protocol Number:Agent Name:Dose Form and Strength:Protocol Title:Dispensing Area:Investigator Name:Investigator or site Numbering No.

How to fill out investigational product accountability record

How to fill out investigational product accountability record

1. Start by recording the name of the investigational product being administered.
2. Include the batch or lot number of the product.
3. Document the quantity of the investigational product being used.
4. Record the date and time of administration.
5. Note down the name of the individual responsible for administering the product.
6. Include any relevant observations or notes regarding the administration of the product.

Who needs investigational product accountability record?

1. Individuals conducting clinical trials or studies involving investigational products.
2. Healthcare professionals responsible for managing and administering investigational products.
3. Regulatory authorities overseeing the conduct of clinical trials.

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What is investigational product accountability record?

An investigational product accountability record is a document used in clinical trials to track the receipt, storage, use, and disposal of investigational products. It ensures that the products are managed in compliance with regulatory requirements and the study protocol.

Who is required to file investigational product accountability record?

The principal investigator and the clinical trial site's study team are typically required to file the investigational product accountability record, ensuring accurate documentation for regulatory compliance.

How to fill out investigational product accountability record?

To fill out an investigational product accountability record, you should include details such as the product name, batch number, quantity received, quantity dispensed, and quantity returned or destroyed, as well as dates and signatures of responsible personnel.

What is the purpose of investigational product accountability record?

The purpose of the investigational product accountability record is to maintain an accurate log of the investigational product's lifecycle within the study to ensure safety, traceability, and compliance with regulatory standards.

What information must be reported on investigational product accountability record?

The information required includes product description, unique identifier, storage location, quantity received, quantity dispensed to participants, quantity returned or destroyed, date of transactions, and signatures of personnel involved.