What is it? Why is it important?

Findings mean that given audit/inspection criteria were not met. Findings occur as a result of a process and/or system deficiency, where audit/inspection evidence do not comply with audit/inspection criteria.


In studies, typical audit/inspection criteria include:


In studies, typical evidence include:


Findings are categorised based on the severity of non-compliance and include the 3 categories, namely minor, major, and critical according to EMA`s grading of inspection findings. Main focus is any non-compliance that jeopardizes the safety of study participants and the quality of study data.


Based in the European Medicine Agency (EMA) findings that are not-met are categorised – as follows:



  • Condition, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data
  • Critical observations are considered totally unacceptable
  • Possible consequences: rejection of data and/or legal action required
  • Observations classified as critical may include a pattern of deviations classified as major



  • Condition, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data
  • Major observations are severe deficiencies and are direct violations of GCP principles
  • Possible consequences: data may be rejected and/or legal action required
  • Observation classified as major may include a pattern of deviations and/or numerous minor observations



  • Condition, practices or processes that would not be expected to adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data.
  • Possible consequences: observations classified as minor indicate the need for improvement of conditions, practices and processes.
  • Many minor observations may indicate poor quality and the sum might be equal to a major finding with its consequences.

What do I need to do?

Findings must be subject to a root-cause analysis. This mean that:

  • Findings must be corrected in order to return to criteria compliance
  • Corrective actions  must be defined in order to prevent the reoccurrence of finding(s) (e.g. risk management)
  • The SP-INV submits a CAPA plan to inspectors that describes the management of findings, including a timeline for their resolution. A priority should be given to critical or major findings.


Based on the outcome of the inspection, the SP-INV is responsible to submit a CAPA plan to the inspectors and ensure the CAPA plan is implemented according to defined timelines.


Example of a finding

The participant signed the document 2 days prior to the Site-INV. Participant and Site-INV did not date and sign the ICF on the same day.

Criteria: Participant and Site-INV must jointly date and sign the ICF during the visit when the participant is informed - and included in the study.

Route cause analysis: Participants receive study information including the ICF document to take home for evaluation. Upon return to the clinic participants have already signed the ICF. The Site-INV is not aware of the requirement that the ICF must be jointly signed on the same day.

Preventive action: Training of Site-INV regarding joint signing criteria. ICF process was adapted. In the event the participant has pre-dated and signed the ICF he/she will re-sign on the day of study inclusion together with the Site-INV.

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

  • 1.29 Inspection
  • 1.6 Audit
  • 5.0 Quality management

ISO 9001 (access liable to costs) – see in particular section

  • QMS Requirements

ISO 19011 (access liable to costs) – see in particular section

  • Guidelines for auditing management systems

EMA – see in particular document

Procedure for reporting of GCP inspections requested by the committee for Medical Products for Human Use (CHMP)

  • Appendix 5: Grading of inspection findings


Swiss Law

ClinO – see in particular articles

  • Art. 46 Agency inspections
  • CAPA – Corrective and Preventative Actions
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EMA – European Medicine Agency
  • GCP – Good Clinical Practice
  • ICF– Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medicinal Device
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TMF/ISF – Trial Master File / Investigator Site File
Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Findings

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Regulatory Inspections ↦ Findings

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