Scope of the Guideline & Definitions

1 Scope of the Guideline
The objective of this Guideline is 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 a clinical trial performed by the sponsor. This Guideline is expected to be a basic principle along with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) [1] for a sponsor’s auditor to conduct an audit in the various situations of each country and sponsor.

2 Definitions

A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and whether the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). (ICHGCP [1])
Audit Certificate
A declaration of confirmation by the auditor that an audit has taken place. (ICH GCP [IJj
Audit Checklist
A working document for recording audit observations.
Audit Findings
The result of the auditor's evaluation of audit observations according to the reference documents.
Audit Observations
A record of the facts observed during auditing and supported by objective evidence.
Audit Report
A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP [I])
Audit Trail
Documentation that allows reconstruction of the course of events. (ICH GCP [1])
Organization being audited. (ISO 19011 [2])
Corrective and Preventive Action (CAPA)
Collective Action is action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence. Preventive Action is action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.
Clinical Trial/Study System
A system for performing a clinical trial established at a sponsor’s organization, participating medical institution, and other trial-related centers (i.e. the organization, structure, procedures, facilities and equipment, etc.).
Compliance (in relation to trials)
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements,
and the applicable regulatory requirements. (ICH GCP [1])
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity. (ICH GCP [1]) Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all
reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subject’s identities and sponsor’s proprietary information. (from the definition of “Direct Access ” of ICH GCP [1])
Direct Access
Permission to examine, analyze, verify, and reproduce any records and reports that are
important to the evaluation of a clinical trial. (ICH GCP [1])
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. (ICH GCP[1])
Effectiveness Verification
The means by which effectiveness of corrective and/or preventive action implementation is
verified by a documented and systemic process
Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP [1J)
Objective Evidence
Data supporting the existence or verity of something.
NOTE: Objective evidence may be obtained through observation, measurement, test, or other means. (ISO 9000 [3])
Quality Assurance
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). (ICH GCP
Quality Control
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for the quality of the trial-related activities have been fulfilled. (ICH GCP flj)
Quality Management
The coordinated activities to direct and control an organization with regard to quality. NOTE: Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives, quality planning, quality control, quality assurance and quality improvement. (ISO 9000 [3])
Quality Management System
Management system to direct and control an organization with regard to quality. (ISO 9000[3])
Quality Policy
Overall intentions and direction of an organization related to quality as formally expressed by top management. (ISO 9000 [3])
Reference Documents
Documents which are used to evaluate compliance (e.g., trial protocols, sponsor’s Standard Operating Procedures .Good Clinical Practice, and the applicable regulatory requirement(s)).
Risk Assessment
A systematic process of organising information to support a risk decision to be made within a
risk management process. It consists of the identification of hazards and the analysis and
evaluation of risks associated with exposure to those hazards. (ICH Q9 Quality Risk Management)
Risk Management
The systematic application of quality management policies, procedures, and practices to the
tasks of assessing, controlling, communicating and reviewing risk. (ICH09 Quality Risk Management)
Root Cause
Is the most basic cause of any undesirable condition or problem, which when eliminated or
mitigated will prevent or significantly reduce the effect of the condition or problem.
Root Cause Analysis
A class of problem solving methods used to identify the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective and preventive measures at root causes, the likelihood of problem recurrence will be minimized.
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of clinical trial. (ICH GCP [1])