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21.0 Post marketing surveillance data (vigilance reporting): The dossier should contain th...

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7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates ...

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Adverse events, adverse device effects and device deficiencies (a) Definitions of adverse ...

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Details about the Investigator: (a) Name; (b) Address; (c) Telephone number; (d) Professio...

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Details about the Investigator: (a) Name; (b) Address; (c) Telephone number; (d) Professio...

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Procedural issues A system shall be established to enable cross-referencing of CRFs and C...

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Data management (a) Procedures used for data review, database cleaning, and issuing and re...

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Top management of the manufacturer shall ensure that responsibilities and authorities are ...

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

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