Governance and Legislation
It is a requirement of the Department of Health's Research
Governance Framework (RGF) that all NHS organisations carry out
formal monitoring of research taking place on their premises, or
involving their patients or staff.
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 Clare Griffin.
Clinical Trials of Investigational
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
The Clinical Trials Regulations apply to
every clinical trial of medicinal products whether sponsored by
Industry, Government, Research Organisations, Charities or
- Establishment of ethics committees on a legal basis
- Licensing/Competent Authority (i.e. MHRA) procedures for trial commencement
- Manufacture, import and labelling of investigational medicinal
- Establishment of inspection systems for Good Manufacturing
Practice (GMP) and Good Clinical Practice (GCP)
- Safety monitoring of trial participants and sets procedures for
reporting adverse drug reactions and events
What do the regulations
The 2004 regulations take account of:
- Pre-trial authorisation - Research Ethics Committees and the
MHRA should respond to a submission within 60 days
- Confidential database of trials - All trials must be registered
on the European Clinical Trials Database (EudraCT)
- Research Ethics Committee approval - The scope and function of
- Protocol amendments - Defines significant amendments and
- Consent process - Subject protection and legal
- Safety reporting - Includes definitions, reporting requirements
- Regulatory notification of trial end - Timelines for
notification to the MHRA and Research Ethics Committee
- Trials supplies and manufacture of Investigational Medicinal
- Trials involving vulnerable subjects
The 2006 amendments take account of:
- Main principles of amendment regulations
- Investigator Brochure - Requires sponsor to annually review and
- Non commercial trials - Provides definition and clarifies IMP
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
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
Information for Clinical Trial
Where can I get a general overview of
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
Is it a clinical trial?
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
and maintaining Trust-wide SOPs
/ Delegation of responsibilities
Approval Process (including amendments)
files and version control
consent in special circumstances - Paediatrics
consent in special circumstances - Incapacitated adults
- Trust-sponsored CTs
- non-Trust-sponsored CTs
event reporting (non CTs)
of study notification
of data, archiving and destroying documents
Passport - Honorary Research Contracts / Letters of Access
and Financial Management
a GCP-compliant protocol - CTIMPs
a GCP-compliant protocol - non-CTIMPs
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:
- Definitions of adverse events
- The responsibilities of investigators for recording adverse
events and the notification of adverse events to sponsors
- The responsibilities of sponsors for reporting to regulatory
authorities and Research Ethics Committees
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