Medicines and Healthcare Products Regulatory Agency (MHRA) Phase I Accreditation Scheme

Located within the heart of the acute hospital setting, Edinburgh CRF's clinical facilities are ideally positioned to provide the infrastructure and expertise to conduct Phase I/ First in Human (FIH) studies safely.


“The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of Phase I clinical trials. Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.”


The adult clinical facilities at the WTCRF and RIECRF have been accredited under the MHRA Phase I Accreditation Scheme since July 2011. The paediatric facilities in our Children’s CRF were accredited in 2015.

Phase I

As an academic facility the CRF delivers accreditation via the following:

Phase I Study Review Committee (PISRC):

Membership
  • Clinicians (adult and paediatric)
  • Experts in:
    • Pharmacology and Toxicology
    • Statistics
  • CRF Directors and Deputy Director
  • CRF Clinical and QA Managers
  • NHS Lothian Research and Development Management
  • Clinical Trials Pharmacist
Function

Conduct a scientific review and clinical risk assessment of Phase I/ FIH studies submitted for conduct in Edinburgh CRF. This review will make particular reference to:

  • Expertise of the Principal Investigator and Research Team in the conduct of early phase trials
  • Trial design
  • Pre-clinical and clinical work already undertaken
  • Dose escalation strategy
  • Risk mitigation
Process

Applications are reviewed using a dedicated Risk Assessment document submitted by the Principal Investigator. If approved a formal risk assessment report based on the EMA guidance on mitigating risk in FIH trials with IMPs is issued. This includes a contingency plan which must be adhered to during the conduct of the trial.

CRF Clinical Team and Facilities

The clinical teams work with research teams to set-up, conduct and deliver trials to the accreditation standard.

  • Dedicated CRF Lead Nurse for Phase I / Education (contact Fiona Mitchell or Lesley Briody)
  • Research nurses trained in Immediate Life Support (ILS) and Good Clinical Practice (GCP)
  • Clinically relevant and experienced research nurses working to competency based training packages where applicable
  • Project assistants and clinical support workers trained in GCP and familiar with trial protocol compliance
  • Located at three of NHS Lothian’s acute hospital sites our accredited adult facilities, the WTCRF at the Western General Hospital and the RIECRF at the Royal Infirmary of Edinburgh, and paediatric facility CCRF at Royal Hospital for Sick Children operate as embedded NHS departments
  • Located with a two minute patient transfer time to Intensive Care and in house clinical facilities

Quality Assurance (QA)

The CRF has a robust Quality Management System in operation to ensure compliance with Research Governance and Regulatory requirements as standard. In addition to this the QA Team:

  • Provide oversight and audit of the Accreditation Scheme specific systems and requirements
  • Administer the PISRC
  • Co-ordinate accreditation and other regulatory inspections ensuring appropriate corrective and preventative actions (CAPA) are implemented

Contact

The CRF welcomes applications for commercial and academic First in Human/ Phase I trials. If you are planning to carry out a Phase I / FIH study in the CRF please make contact with us at the earliest opportunity. The CRF encourages researchers to apply for PISRC review prior to submission to MHRA and REC. Informal enquiries should be directed to the CRF Research Nurse Manager or Deputy Director .