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

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