Get the free Investigational Device Cover Form- IRB Extension - Cahaba GBA

Investigational Device Cover Form IRB Extension/Renewal Alabama Georgia Tennessee Device Name: Device Number: Trial Sponsor: Start Date: IRB Approval End Date: Principal Investigator: Institution:

How to fill out investigational device cover form

How to fill out investigational device cover form:

1. Start by carefully reading the instructions: Before filling out the investigational device cover form, it is crucial to thoroughly read the instructions provided. This will ensure that you understand the requirements and steps involved in completing the form accurately.
2. Provide basic information: Begin by entering your personal details such as your name, contact information, and any other required identification numbers. This information helps in identifying the individual responsible for the investigational device.
3. Specify the investigational device details: Provide accurate and specific information about the investigational device being covered. Include details such as the device name, manufacturer, model number, and any other relevant identification details.
4. State the purpose of the investigational device: Clearly describe the intended purpose of using the investigational device. Explain why it is essential for your specific research or medical procedure. Provide a brief overview of the study or medical application that the investigational device will be utilized for.
5. Outline the safety measures: Demonstrate your understanding of the safety precautions associated with the investigational device. Describe any measures or protocols that will be implemented to ensure the safety of individuals involved, such as patients or study participants. Clearly articulate any potential risks and how they will be mitigated.
6. Include additional supporting documentation: Attach any necessary supporting documents requested in the form. This might include relevant research proposals, study protocols, or prior approval documentation. Ensure that all documents are properly labeled and organized for easy reference.
7. Provide signatures and dates: Sign and date the investigational device cover form to confirm the accuracy of the information provided. Ensure that all required signatures from relevant parties are included, such as principal investigators or supervising physicians.

Who needs investigational device cover form:

1. Researchers conducting clinical trials: Investigators involved in conducting clinical trials that utilize investigational devices are typically required to fill out an investigational device cover form. This form helps ensure that the devices being used have been properly reviewed and approved.
2. Medical professionals using investigational devices: Healthcare professionals who plan to use investigational devices for medical procedures or research purposes may need to complete an investigational device cover form. This helps ensure that all necessary approvals and safety measures are in place.
3. Institutions and organizations overseeing device usage: Regulatory bodies or institutional review boards responsible for overseeing the use of investigational devices often require the completion of an investigational device cover form. This allows them to assess and monitor the appropriate usage of these devices within a given research or medical setting.

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What is investigational device cover form?

The investigational device cover form is a document that provides information about the use of a new medical device in clinical trials or studies.

Who is required to file investigational device cover form?

Medical device manufacturers, researchers, or sponsors are required to file the investigational device cover form.

How to fill out investigational device cover form?

The investigational device cover form can be filled out online through the appropriate regulatory agency's website or submitted through a physical form provided by the agency.

What is the purpose of investigational device cover form?

The purpose of the investigational device cover form is to ensure that new medical devices used in clinical trials or studies are safe and effective for patients.

What information must be reported on investigational device cover form?

The investigational device cover form typically requires information such as the device name, manufacturer, intended use, study protocol, and patient population.