Data

The terms listed below contain links to different sections of the ICH GCP E6 (R3) that contain or are relevant to the term "DATA".

Principle 9. (Reliable results)

Principle 10. (Roles & responsibilities)

Data integrity

Metadata

Source records

Data acquisition tool (DAT)

2.12 Records

3.16.1 Data handling

3.16.3 Record keeping and retention

B.14 Data handling and record keeping

4 Data governance – investigator and sponsor

4.2 Data life cycle elements

4.2.1 Data capture

4.2.2 Relevant metadata, including audit trails

4.2.3 Review of data and metadata

4.2.4 Data corrections

4.2.5 Data transfer, exchange and migration

A.3.7 Summary of data and guidance

B.14 Data handling and record keeping