European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management

    Description

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INFANT - Irish Centre for Fetal and Neonatal Translational Research
Documented adherence to GCP guideline Yes All personnel who conduct research under the auspice of INFANT are GCP trained with up to date certificates. The training is delivered inhouse by personnel who themselves have been validated and trained as trainers and are certified as such. Clinical Research Staff are trained/refreshed at least on an annual basis and detailed training logs are maintained.
Documented adherence to the ethical considerations for clinical trials in children Yes All studies are conducted to the “Ethical considerations for clinical trials on medicinal products conducted with the paediatric population”. Protocols and Clinical Investigation Plans are written according to these guidelines especially the consenting process with regard to obtaining consent in this vulnerable population.
Documented adherence to ethical considerations Yes Applications are submitted to relevant local and national Ethics Committees in each jurisdiction depending on whether the research is a clinical trial of a medicinal product or a clinical investigation of a medical device. Copies of approvals are filed in each site Investigator Site File and also in the overall Trial Master File maintained at the Coordinating site.
Availability of Standard Operating Procedures (SOP) Yes Study specific SOPs are generated for each research project depending on the project but some SOPs are generic in nature and cover all research projects for example Informed Consent Procedure, Safety Reporting, Personnel Training, Serious Breach, Document Control, Document Retention and Archival Procedures, SOP on SOPs. A bespoke suite of SOP’s are available upon request.
Capacity to monitor studies
(academic trials industry sponsored trials)		 Yes Presently each research project has a dedicated monitor experienced in academic/investigator led studies and industry/pharma studies both medicinal products and medical device projects. All projects are monitored according to ICH GCP Guidelines, the applicable EU directive and local/national legislation. Each project has either a Monitoring SOP or Monitoring Plan or both and the scope and percentage of Source Data Verification (SDV) is outlined in these documents and adhered to for the duration of the projects.
Capacity to monitor performance of collaborating centres Yes Each project has a dedicated monitor who oversees and quality controls all aspects of the specific project. This includes monitoring all activities at each participating site and producing initiation, interim and close out reports with documented findings and action points. Training of site personnel and monitoring of site performance is performed on a continuous basis throughout the course of each project and is documented accordingly. Overall quality management is the responsibility of the project/clinical quality manager who quality assures every aspect of the project from protocol generation to final project report.
Quality control and quality assurance, raceability and data safety Yes There is a quality management system in place from a clinical and medical device perspective with clearly designated roles and responsibilities. Quality control and assurance is implemented during each specific project and procedures are clearly outlined in relevant pertinent SOPs. Data safety and management is per ICH GCP, EU guidelines and applicable national legislation. All source data is maintained in both TMF and ISF and there is an electronic audit trail if data is captured in an electronic Case Report Form. Depending on the percentage of SDV outlined in Monitoring Plan/SOP traceability and data assurance and safety is guaranteed. A bespoke suite of SOP’s are available upon request.