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Harmonised
E6(R3) Annex 2

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

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E6(R3) Annex 2

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

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Pre-harmonisation

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

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Harmonised
E7

E7 – Studies in Support of Special Populations: Geriatrics

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In Process
E7

E7 – Studies in Support of Special Populations: Geriatrics

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Pre-harmonisation

E7 – Studies in Support of Special Populations: Geriatrics

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Harmonised
E8(R1)

E8 – General Considerations for Clinical Studies

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In Process
E8(R1)

E8 – General Considerations for Clinical Studies

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Pre-harmonisation

E8 – General Considerations for Clinical Studies

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Harmonised
E9

E9 – Statistical Principles for Clinical Trials

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In Process
E9

E9 – Statistical Principles for Clinical Trials

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Pre-harmonisation

E9 – Statistical Principles for Clinical Trials

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Harmonised
E9(R1)

E9(R1) – Addendum: Statistical Principles for Clinical Trials

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In Process
E9(R1)

E9(R1) – Addendum: Statistical Principles for Clinical Trials

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Pre-harmonisation

E9(R1) – Addendum: Statistical Principles for Clinical Trials

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Harmonised
E10

E10 – Choice of Control Group and Related Issues in Clinical Trials

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In Process
E10

E10 – Choice of Control Group and Related Issues in Clinical Trials

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Pre-harmonisation

E10 – Choice of Control Group and Related Issues in Clinical Trials

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Harmonised
E11(R1)

E11 – Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum

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In Process
E11(R1)

E11 – Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum

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Pre-harmonisation

E11 – Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum

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Harmonised
E11A

E11A – Paediatric Extrapolation

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In Process
E11A

E11A – Paediatric Extrapolation

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Pre-harmonisation

E11A – Paediatric Extrapolation

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