Your Easy Guide to Clinical Studies

Corrective and Preventive Actions (CAPAs) are adaptations and improvements taken to eliminate causes of non-compliance. CAPAs include a set of actions that require:

• A root-cause analysis of the situation or the event
• The implementation of corrective actions that allows for a non-compliant activity to return to compliance
• The implementation of preventive actions with the aim to avoid the reoccurrence of the non-compliant event

 

After an audit/inspection or repetitive and systematic or severe issues identified internally, the SP-INV writes a CAPA plan that lists a response on how to handle noted non-compliance (findings).

As a SP-INV:

• Analyse findings listed in the audit / inspection report
• Define CAPAs for each listed finding
• Write a CAPA plan to be forwarded to the audit or inspection team for approval. Include a timeline stating until when CAPAs will be implemented
• Upon approval by the audit/inspection team, implement the CAPA plan within defined timelines
• As applicable, update the RAF
• In the event of a re-audit or re-inspection, the implementation of a previously approved CAPA plan can be re-evaluated

 

SP-INV Audits

SP-INV can audit participating study sites. Procedures are as described for regulatory inspections. Based on findings, the Site-INV writes a CAPA plan including timelines. The SP-INV approve the CAPAs and supervises its implementation. Upon completion the Site-INV receives an audit certificate to be filed in the ISF.

 

References

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

• Guidance for the preparation of good clinical practice inspection reports and communication of inspection findings

 

Documents

• Risk Assessment Form for Clinical Research Projects