Guideline
The Japan Society of Quality Assurance guideline for Good Clinical Practice auditing
To outline the mission and the organization of a sponsor’s auditing department and the principles for planning, performing and reporting audits, all of which should be considered when the auditor who belongs to the sponsor performs an audit of a clinical trial performed by the sponsor.
The International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) has been adopted by three regions USA, Europe and Japan and implemented since 1996. Details of GCP auditing are not provided in ICH GCP. The Japan Society of Quality Assurance (JSQA) has prepared ‘The JSQA GCP Guideline for GCP Auditing’ to promote the global discussion on GCP auditing and expects to establish a global guideline on GCP auditing along with ICH GCP. The guideline will include the mission and the organization of a sponsor’s auditing department and establish the principles for planning, performing, and reporting audits. The guideline is expected to be a basic principle along with ICH GCP for not only sponsor’s auditors, but also independent auditors and auditors of Contract Research Organizations (CROs) to conduct an audit in the various situations of each country and sponsor.
Reference of the resource
Hiroshi Shimokai, Seiichi Hata, Toshiaki Tamura, Yoshiaki Yano, Shu Abe, Masayuki Takezawa, Masahiro Yogo, Tokuaki Kajiho, Kuniko Gotou, Akio Izawa, Muneyoshi Ookawa, Hiroyasu Yamashita, Fumiko Alaya, Yukiko Shiromoto, and Kiyoshi Takahashi, Quality Assurance Journal 11 (2007) 37–43. DOI: 10.1002/qaj.403
