There must also be Trust-level systems in place for on-going
monitoring of research projects. These measures are in addition to
the more detailed monitoring of studies by the research team and
Study monitoring is carried out by the Trust's Quality Manager (QM) using a research governance tool known as 'MAJIK'. The tool consists of a checklist for determining compliance with the RGF and good clinical practice (GCP).
If you have any questions regarding the monitoring process please contact the Quality Manager, Dr George Gerogiou.
Which regulations apply to Clinical Trials of Investigational Medicinal Products (CTIMPs)?
CTIMPs conducted within the UK are subject to the certain regulations.
These are the Medicines for human use (Clinical Trials) regulations 2004, and the subsequent amendments of 2006 (1&2). These Regulations were introduced following the 2001 European Union Directive on Clinical Trials.
What is the scope of the regulations?
The Clinical Trials Regulations apply to every clinical trial of medicinal products whether sponsored by Industry, Government, Research Organisations, Charities or Universities.
What do the regulations describe?
The 2004 regulations take account of:
The 2006 amendments take account of:
Medicines and Healthcare Products Regulatory Agency - MHRA
What is the MHRA?
The MHRA is the UK Competent Authority for
the regulation of medicines and medical devices. It offers advice
about the use of medicines and products in research, undertakes
inspections of clinical trials and trial centres, and helps in the
preparation of products used in them.
Research involving medicines (but not medical devices) is regulated under the Medicines for Human Use (Clinical Trials) Regulations 2004. All trials of new investigational medicinal products (IMPs) in humans must be authorised by MHRA. No clinical trial of an IMP can commence without a Clinical Trials Authorisation (CTA).
Clinical Trials Authorisations (CTA)
Clinical trials authorisations are provided by the MHRA.
After obtaining a EudraCT number, the trial
sponsor (this is usually delegated to the Chief Investigator)
completes the CTA application form via EudraCT:
European Clinical Trials Database, or the Integrated Research
Application System (IRAS). The application should be saved onto
your computer as an XML file.
The application is designed to establish a number of criteria about the Investigational Medicinal Product and trial protocol. Further information on submitting a CTA to the MHRA is available in the guidance document, or visit the MHRA website (www.MHRA.gov.uk).
Where can I get a general overview of clinical trials?
The Department of Health and the MRC established a joint project to address a range of important issues raised by the academic trials community about the implementation of the EU Clinical Trials Directive in the UK. A valuable output was the development of a dedicated Clinical Trials Toolkit website and interactive "route maps" to help guide investigators through the trial management processes.
Is it a clinical trial?
An algorithm is available that helps researchers determine whether their study is within the scope of the clinical trials regulations. However, researchers should always seek advice and confirmation from the Medicines and Healthcare Products Regulatory Agency's Clinical Trials Helpline, email@example.com
Are there Trust Standard Operating Procedures?
The Research Office has compiled a set of Trust Standard Operating Procedures (SOPs) related to the management of clinical trials. These are available on the Trust website for all researchers to access.
Are there any template documents that the Trust can supply?
The Research Office has prepared template documents that can be used when conducting a clinical trial.
Please telephone the Research Office secretary on 0161 276 3565 for further information. We can also provide individual help and support for trial investigators and those wishing to set up a trial in the Trust.
List of Trust SOPs
Reference Number Title
RDSOP1 Preparing and maintaining Trust-wide SOPs
RDSOP3 Definition / Delegation of responsibilities
RDSOP4 Research Approval Process (including amendments)
RDSOP5 Study files and version control
RDSOP6 Informed consent
RDSOP7A Informed consent in special circumstances - Paediatrics
RDSOP7B Informed consent in special circumstances - Incapacitated adults
RDSOP8A Pharmacovigilance - Trust-sponsored CTs
RDSOP8B Pharmacovigilance - non-Trust-sponsored CTs
RDSOP8C Adverse event reporting (non CTs)
RDSOP9 End of study notification
RDSOP10 Retention of data, archiving and destroying documents
RDSOP11 Research Governance Monitoring
RDSOP12 Research Passport - Honorary Research Contracts / Letters of Access
RDSOP13 Contracts and Financial Management
RDSOP15 Preparing a GCP-compliant protocol - CTIMPs
RDSOP16 Preparing a GCP-compliant protocol - non-CTIMPs
RDSOP17 Research Data Security
RDSOP18 Statistical Management
RDSOP19 Financial Management of Clinical Trial
Safety reporting in clinical trials
UK Clinical Trials Regulations set out the
legal requirements for pharmacovigilance in clinical trials that
The Regulations cover:
Investigators must comply with Trust Standard Operating
Procedures (SOPs) regarding pharmacovigilance and safety reporting
in clinical trials.
Further guidance on can be found in:
Definitions of Adverse Events:
Investigators must make themselves aware of the assessment and safety reporting requirements for the trials that they are involved with. These will be described explicitly in the study protocol or associated Standard Operating Procedure. If in doubt, contact the sponsor. In particular, SUSARs are subject to expedited reporting and must, by law, be notified to the sponsor at the earliest opportunity. The Research Office must also be informed of ALL SAEs and SUSARs occurring within the Trust as soon as possible. A list of Definitions can be downloaded here