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 There is a documented system of audit                                                                                                                                                   

 HTA standard         

 Examples of best practice standards

a)   There is a documented schedule of audits covering licensable activities.

  • The DI and PD will regularly audit collections of relevant and non-relevant material. These audits will be documented and followed up with a report, and if necessary, a Corrective and Preventative Action (CAPA) plan.

  • Custodians of sample collections should conduct self-inspection traceability audits regularly and maintain records, such as an Excel sheet with dates, sample IDs, and findings, tracking from consent forms to sample storage locations and vice versa.

b)   Audit findings include who is responsible for follow-up actions and the timeframes for completion.

  • Audit findings will be documented and if required, a Corrective and Preventative Action (CAPA) plan will be sent to the investigator with a deadline for completion.

 

 

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