Prior to an audit, theauditeeshould expect to receive anaudit plan or agenda, which outlines thescope, objectives, schedule, and logisticsof the audit.
According to theGCDMP (Chapter: Quality Assurance and Audits), anaudit planensures transparency, preparation, and efficient execution. It typically includes details such as:
The audit scope and objectives,
The audit team members,
Documents or processes to be reviewed, and
The audit schedule and timeframe.
This allows the auditee to prepare the necessary records, staff, and facilities. While the auditor’s credentials (option A) may be shared informally, they are not a regulatory requirement.Corrective actions (option B)are outcomes of the audit, not pre-audit materials.Standard Operating Procedures (option C)may be requested during the audit but are not provided in advance.
Thus,Option D – Audit Plan or Agenda– is the correct and compliant answer.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Quality Assurance and Audits, Section 6.1 – Pre-Audit Planning and Communication
ICH E6 (R2) Good Clinical Practice, Section 5.19.3 – Audit Procedures and Responsibilities
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Section 8.1 – Audit Preparation and Planning
