Top 3 deficiencies from EMA GCP inspections in 2016

Top 3 deficiencies from EMA GCP inspections in 2016

EMA recently published 2016 annual inspection report, which describes its inspection activities in 2016. The EMA GCP inspectors working group (IWG) focuses on the harmonisation and coordination of GCP-related activities at EU level.

Most inspections were carried out in the EU/EEA/EFTA (42%) followed by inspections in the USA (28%) and the Middle East/Asia/Pacific (20%).

Most of the inspections were conducted at the clinical investigator sites, followed by the sponsor sites, CRO, analytical laboratory of BE/BA studies, clinical facility of BE/BA studies and analytical laboratory.

The most frequent findings are related to essential documents, for example:

  • lack of essential documents e.g. receipt of IMP shipment to site
  • records of blood samples shipment to the central laboratories;
  • incomplete documentation (e.g. incomplete screening list);
  • lack of contemporaneous independent copy of the CRF filed on site.

 

The second most frequent findings was related to protocol compliance at the investigator site, for example:

  • not all adverse events reported to the sponsor as required per protocol;
  • instructions for SAE follow-up reports not followed
  • inadequate SAE documentation and reporting
  • IMP and concomitant medication protocol deviations
  • protocol visits were not performed within the visit windows specified in the protocol
  • violation of a number of inclusion criteria for some patients;
  • final decision about eligibility not always documented in hospital records.

 

The third most frequent findings were related to trial monitoring by sponsors, for example:

  • monitor has not identified number of deficiencies on site
  • inadequate monitoring activities performed at site
  • lack of escalation process to resolve issues identified by monitor
  • monitor not following monitoring plan

Many other findings were reported in other categories such as source documentation, data management, SOPs, contracts/agreements and qualifications and training. The last included incomplete training documentation, and lack of training for study personnel on trial-related procedures.

Link to the report:

http://www.ema.europa.eu/docs/en_GB/document_library/Report/2017/08/WC500233740.pdf

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