Service Provider

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

Service provider

Contract research organisation (CRO)

Principle 10. (Roles & responsibilities)

2.3 Responsibilities

2.8 Informed consent of trial participants

3.6 Agreements

3.9 Sponsor oversight

3.10.1 Risk management

3.11.2 Audit

3.16.1 Data handling

3.16.3 Record keeping and retention

4.1 Safeguard blinding in data governance

C.2 Management of essential records

C.3 Essentiality of trial records

Nonclinical study

Inspection

Essential records table

Published with Nuclino