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.
References
[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
Acknowledgment
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
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Upcoming Clinical Trials
-
RobotDreams GmbHRecruitingAngina Pectoris | Acute Coronary Syndrome | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial InfarctionAustria
-
Xinhua Hospital, Shanghai Jiao Tong University...RecruitingArtificial Intelligence | Diagnosis | Congenital Heart Disease in Children | Deep Learning | ElectrocardiogramChina
-
Synergy Spine SolutionsMCRANot yet recruitingCervical Degenerative Disc DiseaseUnited Kingdom
-
Minnesota HealthSolutionsNot yet recruiting
-
University of MichiganAtriCure, Inc.Not yet recruitingPain, Postoperative | Intrathoracic ProcedureUnited States
-
University of ExeterAdvanced Growers Limited; Ecog Pro LimitedRecruitingInflammationUnited Kingdom
-
Universiteit LeidenUniversity of AmsterdamNot yet recruiting
-
China-Japan Friendship HospitalRecruitingChronic Kidney Diseases | Lipid Metabolism Disorders | Coronary Heart DiseaseChina
-
Institute of Mental Health, SingaporeNational University of SingaporeNot yet recruiting
-
Northwestern UniversityRecruiting
-
Fangbiao TaoNot yet recruitingPerinatal Depression | Stepped Care
-
Pusan National University Yangsan HospitalNot yet recruitingGynecological Surgery