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Title:*Applicable to:Effective Date:Investigational Device Accountability, Storage, Distribution and Return Beaumont Health01/12/2018Policy Owner:Document Type:Functional Area:Administrative DirectorPolicyClinical
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How to fill out investigational device accountability storage

01
To fill out investigational device accountability storage, follow these steps:
02
Gather all the necessary information and documents related to the investigational device.
03
Ensure that you have a proper storage facility that meets the regulatory requirements for storing investigational devices.
04
Take an inventory of all the investigational devices that need to be stored.
05
Label each device with a unique identifier for easy tracking and identification.
06
Record the details of each device, including its name, manufacturer, serial number, and expiration date.
07
Place the devices in the designated storage area, making sure they are properly secured and protected from damage.
08
Implement regular checks and audits to ensure the integrity and accountability of the stored devices.
09
Keep detailed records of all transactions involving the investigational devices, including any transfers, disposals, or returns.
10
Follow any specific storage guidelines provided by the regulatory authorities or the manufacturer of the investigational devices.
11
Train the personnel responsible for managing the investigational device accountability storage to ensure proper handling and record-keeping.

Who needs investigational device accountability storage?

01
Investigational device accountability storage is needed by organizations involved in clinical trials and medical research.
02
Pharmaceutical companies, research institutions, and hospitals that conduct clinical trials or use investigational devices require a robust and accountable storage system.
03
It ensures compliance with regulatory requirements, protects the integrity of the investigational devices, and facilitates accurate documentation and tracking of these devices throughout their lifecycle.
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Investigational device accountability storage refers to a system for tracking and maintaining records of investigational devices used in clinical trials.
Investigators and sponsors of clinical trials are typically required to file investigational device accountability storage.
To fill out investigational device accountability storage, one must accurately record information such as device model, quantity used, and dates of use.
The purpose of investigational device accountability storage is to ensure the proper tracking and documentation of investigational devices used in clinical trials.
Information such as device serial numbers, expiration dates, and usage logs must be reported on investigational device accountability storage.
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