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How to fill out unc-ch investigational device worksheet
How to fill out UNC-CH investigational device worksheet:
01
Start by gathering all the necessary information about the investigational device. This includes the device name, manufacturer, and any relevant product codes.
02
Fill out the "Study Information" section of the worksheet. This includes details such as the study title, principal investigator, and study ID.
03
Provide a brief description of the investigational device in the "Device Description" section. Include information about its intended use and any unique features.
04
In the "Regulatory Information" section, indicate the regulatory status of the device. Specify whether it is a FDA-approved, investigational, or exempt device.
05
Complete the "Device Classification" section by selecting the appropriate classification for the device. This is based on the risk level and intended use as defined by regulatory guidelines.
06
Fill out the "Device Modification" section if any modifications have been made to the investigational device. Provide details about the modifications and their impact on the device's safety and effectiveness.
07
In the "Device Components" section, list all the components and accessories of the investigational device. Include their names, manufacturers, and intended purposes.
08
The "Device Distribution" section requires information about how the device will be obtained and distributed for the study. Specify whether it will be purchased, loaned, or acquired through another method.
09
Complete the "Device Monitoring" section by indicating the monitoring procedures and frequency for assessing the device's performance during the study.
10
Finally, sign and date the worksheet to indicate your acknowledgment and compliance with UNC-CH investigational device policies.
Who needs UNC-CH investigational device worksheet:
The UNC-CH investigational device worksheet is typically required by researchers, principal investigators, and study coordinators who are involved in studies using investigational devices. These individuals need to accurately complete the worksheet to ensure compliance with regulatory requirements and institutional policies. It serves as a documentation tool for obtaining necessary approvals, tracking the use of investigational devices, and ensuring patient safety during the study.
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