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Good Clinical Practice Integrated Addendum To

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I ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD

www.ich.org

1 1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR 2 GOOD CLINICAL PRACTICE ICH 3 E6(R2) 4 INTRODUCTION 5 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 6 designing, conducting, recording and reporting trials that involve the participation of human 7 subjects. Compliance with this standard provides public assurance that the rights, safety and

  Addendum

Guideline for good clinical practice E6(R2)

www.ema.europa.eu

Integrated Addendum to ICH E6(R1) document. Changes are ... Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance

  Good, Practices, Clinical, Good clinical practice, Integrated, Addendum, Integrated addendum

Integrated Addendum to ICH E6(R1): Guideline for Good ...

database.ich.org

2/8/2017 4 7 Integrated Format of the Addendum •The addendum supplements ICH E6(R1) with additional text. •This guideline should be read in conjunction with other ICH guidelines relevant to clinical trial conduct (for example, ICH E2A, E3, E7, E8, E9, and E11).

  Good, Clinical, Integrated, Addendum, Integrated addendum

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