What is it? Why is it important?

An audit is a systematic evaluation of study related activities including the review of essential documents, with the aim to determine study compliance with study protocol, SOPs, GCP and applicable regulatory requirements.

Audits are generally conducted to assess compliance with QA processes established by the SP-INV. Under special circumstances “for-cause” audits are implemented following the identification of critical issue(s).

SP-INV carries main study responsibility, which includes the implementation of a risk-based QMS.


As an integral part of QA activities, audits are conducted independently and separately from routine monitoring or other quality control functions. In contrast to an evaluation of study risks and monitoring activities, audits are not considered mandatory.

An audit is performed based on the following standardised procedures.

Audit preparation:

  • SP-INV defines audit scope, frequency, how to audit, sites to be audited and form and content of the audit report
  • SP-INV notifies the site of the upcoming audit, and requests applicable study documents for review
  • SP-INV forwards the audit agenda to the Site-INV

Audit conduct:

  • Opening meeting. The audit team informs about aim and scope of audit
  • Auditors perform the audit (e.g. review processes and related documents, interview study staff on tasks and responsibilities)
  • Closing meeting. Auditors address remaining open questions and summarise audit findings

Audit follow-up:

  • Auditors write an audit report summarising all findings and forwards to the SP-INV
  • The Site-INV provides auditors with a CAPA plan, initially submitted and accepted by the SP-INV on how to correct and prevent findings. A timeline needed until resolution is included as well as any responsible staff handling the finding.

An audit can target a given study but also its partners and service providers (e.g. laboratories, manufacturers, monitors, CROs).

What do I need to do?

As part of the QA strategy:

  • Establish an audit plan that defines, who-, what-, when- and how to audit
  • Use a risk based approach when planning the audit and focus on those study aspects holding the highest risk
  • Adapt the audit scope according to study complexity, number of participants
  • Select auditors that are independent of the study or system to be audited
  • Ensure auditors are qualified by training and experience


For more information refer to Documents in this Study Guide


  • Any findings observed during an audit are documented in an audit report
  • Findings are categorised according to level of risk to study participants and to the quality of study data (e.g. minor, major, and critical findings)
  • The auditee must provide the SP-INV with a CAPA plan, where corrective and preventative actions are defined (e.g. Site-INV, laboratory performing analysis for the study, outsourced services such as monitoring, data management, statistics)
  • CAPA resolutions are given specific timelines, with high risk findings requiring immediate action on the part of the study site
  • Upon successful audit completion auditors can issue an audit certificate that is forwarded to the SP-INV to be filed in the TMF

In order to be sustainable, the auditee or the Site-INV responsible for a specific site is responsible to implement any corrective measures as defined in the CAPA plan. Thus, applicable control measures should be in place in order to ensure compliance.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guidelines

  • 1.6 Audit definition
  • 5.18 Study monitoring
  • 5.19 Audit

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)
  • CAPA – Corrective and Preventative Action
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • GCP – Good Clinical Practice
  • QA – Quality Assurance
  • QMS – Quality Management System
  • SOP – Standard Operating Procedures
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Development ↦ Quality and Risk ↦ Quality Assurance ↦ Audit

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Quality and Risk ↦ Quality Assurance ↦ Audit

Please note: the Easy-GCS tool is currently under construction.