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 assess study compliance with the study protocol, study SOPs, ICH GCP, EC, including applicable regulatory requirements (e.g. Swissmedic, FOPH).


Audits are generally conducted to assess compliance with Quality Assurance (QA) processes established by the SP-INV of the study. Under special circumstances “for-cause” audits are implemented following the identification of critical issue(s) during monitoring, or the suspicion of non-compliance.


The 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 initiated by the SP-INV of a study, and is based on the following standardised activities.


Audit preparation, the SP-INV:

  • Defines the audit scope, frequency, how to audit or type (e.g. on-site or central), sites to be audited and form and content of the audit report
  • Notifies the participating study site (e.g. Site-INV) of the upcoming audit, and requests applicable study documents for review
  • Forwards the audit agenda to the Site-INV


Audit conduct:

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


Audit follow-up:

  • Auditors write an audit report summarising findings and distributes them to the SP-INV and Site-INV
  • Based on the audit report, the Site-INV provides auditors with a CAPA plan
  • The CAPA plan is submitted to the SP-INV who approves the plan on how to correct and prevent findings. The plan includes a timeline needed for the resolution of finings with a reference to staff responsible for handling the findings


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

What do I need to do?

As a SP-INV define your study`s Quality Assurance 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 (e.g. participant safety, data quality)
  • Adapt the audit scope according to the complexity of your study and the number of participants
  • Select auditors that are independent of the study or system to be audited
  • Ensure auditors are qualified by training and experience


  • Any findings observed during an audit are documented in an audit report
  • Findings are categorised according to level of risk to study participants and quality of study data (e.g. minor, major, and critical findings, according to EMA's grading of inspection findings)
  • The auditee provides the SP-INV and auditors with a CAPA plan, where corrective and preventative actions are defined
  • CAPA resolutions are given specific timelines, with high risk findings requiring immediate action on the part of the study site
  • Upon the successful completion of an audit, auditors can issue an audit certificate that is forwarded to the Site-INV to be filed in the ISF


In order to be sustainable, the auditee or the Site-INV responsible for a specific study 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 CAPA 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 (access liable to costs) – see in particular section

  • Quality Management Systems
  • CAPA – Corrective and Preventative Action
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • QA – Quality Assurance
  • QMS – Quality Management System
  • SOP – Standard Operating Procedures
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Quality Assurance ↦ Audit

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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