Recent Findings in GCP Inspections

The EMA published the annual report of the 2019 Good Clinical Practice Inspectors’ Working Group (GCP IWG) together with the 3-year work plan for the GCP IWG.

Annual Report of the GCP Inspectors’ Working Group

The agency noted that the delay of the 2019 report is due to prioritization of activities for the preparation of the Agency’s relocation (i.e., move from London to Amsterdam) and the COVID-19 pandemic. A total of 1491 deficiencies, comprising 151 critical, 807 major and 533 minor findings were recorded for the 120 inspections conducted. The main two finding categories are “General” and “Trial Management (Sponsor)”, followed by “Investigational Site”, "Investigational Medicinal Products (IMPs)", "Computer Systems" and "Informed Consent". Some examples of findings in the top sub-categories of the main two categories are:

General

• Essential Documents:
  • The Trial Master File (TMF) was not ready for inspection and relevant documents were either not filed, filed late or located outside the TMF structure.
  • Lack of essential documents, e.g. receipt of IMP shipment to site.
• Source Documentation:
  • Missing source documents.
  • Lack of document specifying location of source data.
• Qualification / Training:
  • Incomplete training documentation.
  • Inappropriate oversight of the vendors.
  • Lack of training of study personnel on trial related procedures.
• SOPs:
  • Lack of evidence that sponsor SOPs have been followed and used.
  • SOPs not updated as required.
  • Sponsor failure to implement an efficient quality management system (QMS).
• Contracts / Agreements:
  • Incomplete contracts in place.
  • Responsibilities not clearly defined. 
• Organization and Personnel:
  • Deficiencies regarding the delegation of trial related duties.
  • Tasks performed by staff not authorized to do so.

Trial management (Sponsor)

• Monitoring:
  • Monitor has not identified number of deficiencies on site.
  • Lack of escalation process to resolve issues identified by monitor.
  • Monitor not following monitoring plan.
• Data Management:
  • Inappropriate system for reporting protocol violations.
  • Data management activities were only undertaken after the clinical conduct of the trial was completed.
• Clinical Study Report (CSR):
  • Inconsistencies between source data and data reported in the CSR.
  • Inaccurate information reported in the CSR.
  • Relevant information missing in the CSR.
• Case Report Form (CRF):
  • The design of the CRF is not suitable to accurately collect the data specified within the protocol.
  

EMA´s work plan for the GCP IWG

The EMA also published the 3-year work plan for the GCP IWG. Amongst others the IWG noted to further

• engage with stakeholders on topics such as electronic data systems, data integrity, data protection in clinical trials and innovative trials, complex and decentralized trials. The IWG is still working on the draft Guideline on electronic systems and electronic data in clinical trials.
  
• develop new and review existing EMA GCP inspection procedures and guidelines in relation to the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR) and transparency of inspections.

More information can be found in the Annual Report of the Good Clinical Practice Inspectors’ Working Group 2019, and EMA´s Work Plan 2021-2023 of the Good Clinical Practice Inspectors Working Group.