ICH E6(R1): Good Clinical Practice, 1/97
$0.00
ICH Good Clinical Practice for pharmaceuticals from 1997. See sections 1.22, 4.9.3, 5.5.3, and 6.4.9 for specific computer and validation requirements.ﾠ
Topics include audit trails, system validation, system SOPs, and back-ups.
NOTE: E6(R2) draft was published for public consultation in 2015. Once approved, this version will replace E6(R1).
| Issuing Body | ICH Guidelines |
|---|
You may also like…
-
ICH E6(R2): Good Clinical Practice, 6/15
June, 2015, ICH consensus draft for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
$0.00 Add to cart -
EMA E6(R2): Guideline for Good Clinical Practice, 7/15
July, 2015 consensus draft of ICH E6(R2) for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
$0.00 Add to cart
