What does it take to close a clinical trial center?

Closing the clinical trial center requires the following eight tasks:

(1) Notice: Submit the letter of center closure to researchers, medical device clinical trial institutions and ethics committees and thank them;

(2) Verification data: completeness of investigator's folder, completeness of subjects' folder, informed consent form, original medical record, CRF, inquiry form, random envelope, etc.

(3) Fees: verify the number of cases entered, settlement fees and final payment;

(4) Application: Assist the researcher to apply to the Ethics Committee for closing the topic, defending, submitting ethics fees, violating the plan, etc.

(5) Signature and seal: signature of the researcher and seal of the clinical trial institution of medical devices;

(6) Material and equipment recovery: equipment recovery, material recovery, emergency envelope recovery (double blind), and submission of equipment destruction letter;

(7) Data preservation: confirm the preservation requirements of relevant documents and data of the research institution (at least 10 years after the end of the test);

(8) Verification preparation: Ensure that researchers understand the possibility of verification, notification procedures, preparations, etc.

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