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Research compliance

NSFT Research policies
At NSFT Research, we have developed the following policies about setting up and conducting clinical research in the Trust.

Policies are in PDF format, and contain templates for use by researchers. Editable version of templates are also available from  Further guidance about conducting research in practice is available on the Researcher section of the website.

SOP # Short Title Date Approved Published Download

Confirming research Capacity and Capability

24/11/2016 01/01/2017



R&D003 Research Integrity, Fraud and Misconduct 29/06/2017 01/07/2017


R&D005 Conducting Clinical Trials of Investigational Medicinal Products 26/06/2017 01/07/2017


R&D008 Research Trial Management: Trial Master Files and Site-Specific Files 27/04/2017 01/05/2017


R&D009 Research Auditing and Monitoring Procedures 27/04/2017 01/05/2017

RD009      ​

R&D012 Gaining Valid Informed Consent from Participants for the Purpose of Research Studies 29/07/2017 01/08/17


R&D013 Research Study Close-down and Archiving Procedures 25/05/2017 01/06/2017


R&D016 Research Adverse Event and Safety Reporting Procedures 01/01/2017 02/02/2017



SAE Form:

R&D029 Income Distribution from NIHR Adopted Industry Sponsored Studies 27/10/2016 01/11/2016


NSFT Research Operating Capability Statement
NSFT Research has an R&D Operational Capability Statement, endorsed by the Trust Board of Directors, which outlines our organisational capacity to undertake research:

NIHR B01 RnD Ops Capability May 2011


NIHR PID Reporting Data 2014
The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical trials. In 2013 the NIHR requested that providers of NHS services publish outcomes of clinical trial research against certain benchmarks. From October 2014, the NIHR funding to providers of NHS services became conditional on the reporting of and meeting the two benchmarks of:

  • Recruiting the first patient within the 70 day time period from submission of the study

  • Delivery against the recruitment target agreed for the NSFT site.

The performance below reflects studies which are considered to be interventional or clinical trials only.

Performance in Initiating: Clinical Trials

Performance in Initiating Q4 2017-2018
Performance in Initiating Q3 2017-2018

Performance in Initiating Q2 2017-2018

Performance in Initiating Q1 2017-2018

Performance in Initiating Q4 2016-17
Performance in Initiating Q3 2016-17

Performance in Initiating Q2 2016-17 

Performance in Initiating Q1 2016-17

Performance in Initiating Q4 2015-16

Performance in Initiating Q3 2015-16

Performance in Initiating Q2 2015-16

Performance in Initiating Q1 2015-16

Performance in Initiating Q4 2014-15

Performance in Initiating Q3 2014-15

Performance in Initiating Q1 Q2 2014-15


Performance in Delivering: Commercial Studies

Performance in Delivering Q4 2017-18

Performance in Delivering Q3 2017-2018

Performance in Delivering Q2 2017-2018

Performance in Delivering Q1 2017-2018

Performance in Delivering Q4 2016-17
Performance in Delivering Q3 2016-17

Performance in Delivering Q2 2016-17

Performance in Delivering Q1 2016-17

Performance in Delivering Q4 2015-16

Performance in Delivering Q3 2015-16

Performance in Delivering Q2 2015-16

Performance in Delivering Q1 2015-16

Performance in Delivering Q4 2014-15

Performance in Delivering Q3 2014-15

Performance in Delivering Q1 Q2 2014-15


National Research Guidance, Frameworks and Policies

European directive for Clinical Trial Regulations:

European commission website has lots of useful information regarding the clinical trial European directive.

UK Clinical Trial Regulations

An Introduction to the UK Clinical Trial regulations

UK legislation

Research Governance Framework

Mental Capacity Act – Research Q&A

Mental Capacity Act 2005 QnA

Approving research under MCA section 34

MRC ethics guides


Informed Consent for Adults lacking capacity

Personal Information

Research Quality Service
To ensure that the research we conduct complies with regulations and codes of practice, the NSFT has a Research Quality Lead role, which oversees research practice in the Trust in the following ways, to help local research teams and service users feel confident the research we conduct:

Training needs analysis: Identifying the need for research related training within the Trust, developing, promoting and delivery of training both internally and externally.

Study set up: To assist on the set up of both portfolio and no portfolio studies within the Trust. This may include advice, support of trial management, informed consent process and trial file set up and management.

Monitoring: To ensure that the legal, national and organisational policies and frameworks are being adhered to. This includes the principle of GCP and Declaration of Helsinki (1964).