11 Keeping Audit Records

Audit records should be kept according to sponsor’s SOPs for record keeping. The SOPs should specify the procedures for keeping or destroying audit-related records, as well as the place, subject, and duration of record keeping.

[1] ICH GCP. ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice, Recommended for Adoption at Step 4 of ICH process, 1 May 1996
[2] ISO 19011. Guidelines for quality and/or environmental management systems auditing.
first edition 1 October 2002 [3] ISO 9000. Quality management systems – Fundamentals and vocabulary, second edition.
15 December 2000

The global project participants:
Discussion leader: MaryEllen Lander Members
- Elliott Graham
- Eric Humes
- Ernest Pile
- Jenipher Dalton
- Tammy Lesko
- Tammy Schepp-Little
- Tobin Guarnacci

Discussion leader: Patricia Fitzgerald Members:
- Bruce Seymour-Taylor
- Vaska Tone

Discussion leader: Hiroyasu Yamashita Members:
- Kuniko Gotoh
- Kurumi Wada
- Masahiro Yogo
- Masayuki Takezawa
- Seiichi Hata
- Shigeru Makizaki
- Shu Abe
- Toshiaki Tamura
- Tsuyoshi Kurose
- Yoshiaki Yano