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If the medical device is intended to treat serious or lifethreatening diseases, occurring...

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A checklist of essential elements to be included in the study subject's informed consent ...

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Where a subject is not able to give informed consent (e.g. an unconscious person or a min...

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

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

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

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

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Types of Case Report Forms The following is a suggested list of CRFs that may be developed...

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

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