Clinical Investigations
Clinical Investigations Guidance
ABHI will welcome feedback and comments on the documents below.
Clinical Research Flowchart
Sets out in schematic form the processes through which a manufacturer should go when carrying out a clinical investigation for the purposes of CE marking a new medical device.
Clinical Investigations Checklist
The checklist should be used as part of the documentation process when carrying out a clinical investigation. It provides a step-by-step guide to carrying out a clinical investigation and can be used to track progress and the associated documentation.
Clinical Investigations Reference Documents
The reference list gives details of relevant guidance notes, standards and other relevant documents for carrying out clinical investigations in the EU.
Clinical Investigations Compensation Guidelines
The guidelines set out draft provisions for volunteer agreement and consent forms.
Clinical Investigations Position Paper
The position papers sets out ABHI's thinking with regard to clinical investigations
Clinical Investigations Form of Indemnity
This is a standard indemnity form for manufacturers carrying out clinical investigations on medical devices.
EU Clinical Investigations Guidance
The following documents can be found on the European Commission web site:
MHRA Guidance
The following documents are available on the MHRA website:
- Guidance Note 1 - Guidance Notes for Manufacturers on Clinical Investigations to be carried out in the UK
- Guidance Note 3 - Information for Clinical Investigators
- Guidance Note 5 - Guidance on Biocompatibility Assessment
- Guidance Note 17 - Guidance Notes for Manufacturers on Statistical Considerations for Clinical Investigations on Medical Devices
Model Clinical Investigations Agreement
ABHI worked closely with the Department of Health in developing the model Clinical Investigations Agreement (mCIA). This is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service.
Versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.
The bipartite mCIA for use by NHS Trusts and the medical technology industry has also been adapted for use in a tripartite format by NHS bodies, sponsors and Contract Research organisations (CRO). The changes made to the mCIA are based on the changes made to the mCTA in developing the CRO mCTA.
The tripartite agreement can now be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation.
The tripartite agreement has been reviewed by representative bodies as before (NHS Hospitals, the NHS Confederation, the NHS R&D Forum, the Medical Schools Council, medical technology companies, CROs, ABHI and the CCRA). All the bodies have either endorsed the CRO mCIA or do not object to its use as a standard agreement template for investigations of medical technology devices.
Versions of the CRO mCIA for use in the Devolved Administrations have also been developed.