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E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA - PharmaFacts
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E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

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For questions regarding this draft document contact (CDER) Christian Grimstein 301-796-5189 or (CDRH) Eunice Lee 301-796-4808.

INTERNATIONAL CONCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

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Current Step 2 version dated 10 December 2015

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.

E18 Document History

Code

History

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Approval by the ICH Assembly under Step 2 and release for public consultation.

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10 December 2015

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ICH HARMONISED GUIDELINE

GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA

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Draft ICH Consensus Guideline
Released for Consultation on 10 December 2015, at Step 2 of the ICH Process

TABLE OF CONTENTS

INTRODUCTION .......................................................................................................... 5

Objectives of the Guideline .............................................................................................. 5 Background ....................................................................................................................... 5 Scope of the Guideline ...................................................................................................... 6 General Principles ............................................................................................................. 6 GENOMIC SAMPLING................................................................................................ 7 Collection and Processing of Samples .............................................................................. 7 2.1.1. Specimen Type .................................................................................................. 8 2.1.2. Timing of Specimen Collection......................................................................... 8 2.1.3. Specimen Preservation Conditions .................................................................. 8 2.1.4. Specimen Stability and Degradation................................................................ 9 2.1.5. Specimen Volume and Composition ................................................................. 9 2.1.6. Parameters Influencing Genomic Sample Quality ........................................... 9 2.1.7. Sources of Interference ................................................................................... 10 Transport and Storage of Samples ................................................................................ 10 2.2.1. Transport of Samples...................................................................................... 10 2.2.2. Storage of Samples ..........................................................................................11 2.2.3. Curation of Sample Inventory .........................................................................11 GENOMIC DATA..........................................................................................................11 Generation of Genomic Data .......................................................................................... 12 Handling and Storage of Genomic Data ......................................................................... 12

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4. PRIVACYANDCONFIDENTIALITY......................................................................13

4.1. Coding of Samples and Data........................................................................................... 13 4.2. Access to Genomic Samples and Data............................................................................ 13 5. INFORMED CONSENT .............................................................................................. 14 6. TRANSPARENCY AND COMMUNICATION OF FINDINGS.............................. 14