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Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for subject ...

2023-07-11T04:39:40

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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

2023-07-12T05:23:23

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UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investig...

2023-07-12T04:56:33

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Device accountability Description of the procedures for the accountability of investigatio...

2023-07-11T04:46:09

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Clinical investigation team Briefly describe the administrative structure of the clinical ...

2023-07-12T05:23:02

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Ethics Committee This section shall document that the clinical investigation was conducted...

2023-07-12T05:21:00

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Vulnerable population (a) Description of the vulnerable population. (b) Description of the...

2023-07-11T05:30:29

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Monitoring plan General outline of the monitoring plan to be followed, including access to...

2023-07-11T04:44:12

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Additional elements, which may be required (a) Statement of foreseeable circumstances und...

2023-07-12T04:51:36

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