Phase I Toolkit

When adapting for local use please ensure that the authors are acknowledged and that you work with your Quality Assurance Manager, where appropriate, to ensure documentation is suitable for implementation.   If you have any questions you can email ukcrf.network@nihr.ac.uk.

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The following documents can be downloaded below:

1. Risk Stratification Matrix and Contingency Plans to risk assess a phase I classified study and allow pragmatic and risk-adapted approach to manage hazards associated with the trial. This document can be completed by one site and shared with all others involved in the same study.

2. Phase I Governance Standards Framework provides a guide to the enhanced governance processes that will allow CRFs to work to a minimum agreed standard for the highest risk studies. We have some beginner training videos to support the implementation of this framework and the support risk matrix. 

3. Early Phase Bed-Space Checklist has been designed to provide a framework for final safety checks. The checklist ensures all safety governance procedures are in place prior to exposing participants to investigational medicinal products (IMP).

4. Emergency Scenario Training Guidance and Templates to support the planning and management of clinical emergency training within CRFs. The document includes a scenario delivery tool, five core adult scenarios, five core paediatric scenarios and a debriefing tool.

5. UKCRF MHRA Phase I Accreditation Gap Analysis Tool for units applying for accreditation under the MHRA Phase I Accreditation Scheme to demonstrate that they have systems in place which surpass basic GCP standards for avoiding harm to trial participants and for handling medical emergencies. 

The PDF version of the Framework for conducting highest risk phase I studies can also be downloaded here.

The MHRA Phase I Accreditation Scheme is a voluntary scheme for organisations conducting Phase I clinical trials.

The scheme is designed to give assurance that accredited units have systems and procedures in place that surpass basic GCP standards for avoiding harm to trial participants and for handling medical emergencies should they arise. To achieve and maintain accreditation, units must undergo rigorous regulatory inspection and periodic re-inspection by the MHRA in order to demonstrate that these standards are being met consistently.

Since the early days of the scheme, CRFs have worked with the MHRA to develop an understanding of how the requirements can be met in a non-commercial, hospital-based setting, and to adapt the guidelines to allow this where appropriate. This includes the use of an early phase committee, a model pioneered by Edinburgh CRF, to risk assess trials and provide expert support for investigators.

 There are three non-commercial CRFs with Phase I Accreditation:

• Edinburgh Clinical Research Facility (WTCRF, RIECRF & CCRF) 

• NIHR Guy’s & St Thomas Clinical Research Facility (Guy's Unit)

• NIHR Liverpool Clinical Research Facility 

To find out more about the scheme and see the full list of accredited units, visit the MHRA website:  MHRA Phase I Accreditation Scheme . If you would like to see examples of early phase risk assessments and other documentation used by CRFs to support their Phase I Accreditation, please email us at ukcrf.network@nihr.ac.uk.

UKCRF MHRA Phase I Accreditation Gap Analysis Tool

For units applying for accreditation use the UKCRF MHRA Phase I Accreditation Gap Analysis Tool to demonstrate that you have systems in place which surpass basic GCP standards for avoiding harm to trial participants and for handling medical emergencies. Download #5 from the Phase I Toolkit above.