Who is responsible for making the initial risk determination for a device being used in a study?

Who is responsible for making the initial risk determination for a device being used in a study www.clickanswer.us

Who is responsible for making the initial risk determination for a device being used in a study?

ANSWER :

The person responsible for making the initial risk determination for a device being used in a study is the sponsor-investigator.

The sponsor-investigator is an individual that initiate and conduct investigation. The sponsor investigator also takes up the responsibility as the study's sponsor.

Further Explanation

However, the sponsor-investigator must comply with the required rules and regulations that has to do with sponsor and investigator.

Here are some of the responsibilities of sponsor-investigator in any clinical trial.

The sponsor-investigator must ensure that investigation is conducted in line or according to the statement signed by the investigator, investigational plan and applicable regulations.

The sponsor-investigator must ensure proper monitoring of clinical study

The sponsor-investigator must ensure that the necessary ethic review and approval are dully obtained.

The sponsor-investigator must secure funds for the clinical trial

The sponsor-investigator must apply for appropriate insurance

The sponsor-investigator are to ensure necessary resources are available throughout the course of the study, resources such as staffs, clinical supplies, investigational product, laboratory etc.

The sponsor-investigator must ensure that a qualified IRB must be responsible for the review and approval of the study.

The sponsor-investigation must report any changes or problems that poses risk to human subject to the IRB, also no changes should be made to study process without the approval of IRB  (institutional review board)

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