GCP Audits Service

JMDC provides auditing services for medical device clinical trials, as an independent organization.
The compliance status will be evaluated in terms of clinical trial facilities, document control, monitoring activities, and personnel. All deficiencies identified during the GCP audits will be noted in the audit report with gap analysis and proposed corrective actions.
We can develop and deliver a complete auditing project for you or simply help with specific elements.

The services include following items.

  • Preparation of audit plan and check lists
  • GCP audits (compliance with study protocol, SOPs, and applicable GCP regulations)
  • Audit reports with findings and suggestions

Vendor Qulification GCP Audits

  • Evaluate clinical sites and facilities
  • Assess qualifications of CRO and other third party vendors
  • Assess Vendor Certification programs
  • Assess qualification and training of personnel
  • Review organizational structure and SOP content

GCP Auditing of Investigators/Study Sites

  • Inspect site facilities and equipment
  • Assess compliance with applicable GCP regulations and guidelines, International Conference on Harmonization (ICH) guidelines, the sponsor/CRO’s SOPs, and the protocol
  • Review records and procedures concerning interactions with the IRB
  • Review records and procedures concerning traceability of Medical Devices
  • Review records and procedures concerning Adverse Event (AE) reporting, human subject protections, and subject enrollment criteria
  • Verify that data collected in Case Report Forms are supported by source documents

Sponsor/Contract Research Organization GCP Audits

  • Verify that the protocol is performed according to applicable regulations, guidelines, and standards
  • Review procedures for site visits and associated documents, such as monitoring reports and logs
  • Review the qualifications and training of the CRO project team members
  • Review the contents of SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations, including SOPs for AE/SAE reporting, subject randomization, clinical monitoring, and data handling
  • Assess compliance with internal SOPs

Institutional Review Board GCP Audits

  • Assess compliance with MHLW regulations and ICH guidelines
  • Review records and documentation of meetings and expedited review
  • Evaluate the databases used to track SAEs and Safety Reports
  • Review the contents of SOPs
  • Assess compliance with internal SOPs

JMDC also provides consultant services for GCP inspection by PMDA (Japanese authority).

Draw up an audit schedule and plan
Notice of GCP inspection
GCP inspection
Report of GCP inspection
suggestion for improvement and Inspection of the follow up
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