ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

3.16 Data and Records ......................................................................................................... 39

3.16.1

Data Handling ........................................................................................... 39

3.16.2

Statistical Programming and Data Analysis ............................................. 43

3.16.3

Record Keeping and Retention .................................................................. 43

3.16.4

Record Access ............................................................................................ 44

3.17 Reports ......................................................................................................................... 44

3.17.1

Premature Termination or Suspension of a Trial ..................................... 44

3.17.2

Clinical Trial/Study Reports ...................................................................... 44

4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR ............................ 45

4.1 Safeguard Blinding in Data Governance .....................................................................45

4.2 Data Life Cycle Elements ............................................................................................46

4.2.1

Data Capture ............................................................................................. 46

4.2.2

Relevant Metadata, Including Audit Trails ............................................... 46

4.2.3

Review of Data and Metadata ................................................................... 47

4.2.4

Data Corrections ....................................................................................... 47

4.2.5

Data Transfer, Exchange and Migration .................................................. 47

4.2.6

Finalisation of Data Sets Prior to Analysis ............................................... 47

4.2.7

Retention and Access ................................................................................. 48

4.2.8

Destruction ................................................................................................ 48

4.3 Computerised Systems ................................................................................................. 48

4.3.1

Procedures for the Use of Computerised Systems ..................................... 48

4.3.2

Training ..................................................................................................... 48

4.3.3

Security ...................................................................................................... 49

4.3.4

Validation .................................................................................................. 49

4.3.5

System Release .......................................................................................... 50

4.3.6

System Failure ........................................................................................... 50

4.3.7

Technical Support ...................................................................................... 50

4.3.8

User Management ..................................................................................... 50

APPENDICES ........................................................................................................................ 52

Appendix A. INVESTIGATOR’S BROCHURE ................................................................ 52

A.1 Introduction .................................................................................................................. 52

A.2 General Considerations ................................................................................................ 53

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