What is it? Why is it important?
Findings are results of a process where audit/inspection criteria are compared against audit/inspection evidence.
Findings means that given criteria were not met. There are 3 categories with minor-, major-, and critical finding.
Audit criteria may include:
- Study protocol, SOPs
- GCP, ISO and regulatory requirements
Evidence include verifiable study documents, such as:
- Essential documents in TMF/ISF
- Signed and dated IC
- IMP/MD handling
- Safety reporting procedures
- Evidence also originates from staff interviews
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?
Non-met findings must be subject to a root-cause analysis.
- Means to correct findings must be defined in order to return to criteria compliance
- Preventative action or processes must be defined in order to prevent reoccurrence of finding(s)
- A CAPA report is written summarising handling of non-met findings. A timeline is included stating until when CAPAs will be processed
Example of a finding
Criteria: Participant and Site-INV must jointly date and sign the IC during the visit when the participant is informed - and included in the study.
Route cause analysis: Participants receive study information including the IC document to take home for evaluation. Upon return to the clinic participants have already signed IC. The Site-INV is not aware of the requirement that the IC must be jointly signed on the same day.
Preventative action: Training of Site-INV regarding joint signing criteria. IC process was adapted. In the event the participant has pre-dated and singed the IC 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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 1.29 Inspection
- 1.6 Audit
- 5.0 Quality management
ISO 9001 – see in particular section
- QMS Requirements (access liable to costs)
ISO 19011 – see in particular section
- Guidelines for auditing management systems (access liable to costs)
EMA – Classification and analysis of GCP inspection findings
ClinO – see in particular articles
- Art. 46 Agency inspections