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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 rdofficemailbox@nsft.nhs.uk.  Further guidance about conducting research in practice is available on the Researcher section of the website.

SOP # Short Title Date Approved Published Download
R&D001 Obtaining Research Approvals in the NSFT 26/09/2013 27/09/2013 RnD001.pdf
R&D003 Research Integrity, Fraud and Misconduct 26/06/2014 27/06/2014 RnD003.pdf
R&D005 Conducting Clinical Trials of Investigational Medicinal Products 26/06/2014 27/06/2014 RnD005.pdf
R&D008 Research Trial Management: Trial Master Files and Site-Specific Files 29/03/2012 01/03/2012 RnD008.pdf
R&D009 Research Auditing and Monitoring Procedures 26/09/2013 27/09/2013 RnD009.pdf
R&D012 Gaining Valid Informed Consent from Participants for the Purpose of Research Studies 26/09/2013 27/09/2013 RnD012.pdf
R&D013 Research Study Close-down and Archiving Procedures 26/09/2013 27/09/2013 RnD013.pdf
R&D016 Research Adverse Event and Safety Reporting Procedures 29/08/2013 30/08/2013

RnD016.pdf

Guidance:
SAEguidance.pdf

SAE Form:
SAEform.pdf

R&D029 Industry-Costing Distribution 28/07/2011 28/07/2011 RnD029.pdf

 
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.pdf

 

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 2016-17.pdf

Performance in Initiating Q3 2016-17.pdf

Performance in Initiating Q2 2016-17.pdf 

Performance in Initiating Q1 2016-17.pdf

Performance in Initiating Q4 2015-16.pdf

Performance in Initiating Q3 2015-16.pdf

Performance in Initiating Q2 2015-16.pdf

Performance in Initiating Q1 2015-16.pdf

Performance in Initiating Q4 2014-15.pdf

Performance in Initiating Q3 2014-15.pdf

Performance in Initiating Q1 Q2 2014-15.pdf

 

Performance in Delivering: Commercial Studies

Performance in Delivering Q4 2016-17.pdf

Performance in Delivering Q3 2016-17.pdf

Performance in Delivering Q2 2016-17.pdf

Performance in Delivering Q1 2016-17.pdf

Performance in Delivering Q4 2015-16.pdf

Performance in Delivering Q3 2015-16.pdf

Performance in Delivering Q2 2015-16.pdf

Performance in Delivering Q1 2015-16.pdf

Performance in Delivering Q4 2014-15.pdf

Performance in Delivering Q3 2014-15.pdf

Performance in Delivering Q1 Q2 2014-15.pdf

 

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.

ec.europa.eu/health/human-use/clinical-trials/index_en.htm

UK Clinical Trial Regulations

An Introduction to the UK Clinical Trial regulations

www.chcuk.co.uk/pdf/2011-09-01_UK_Clinical_Trials_Regulations-(Stuart_McCully)_Low_Res.pdf

UK legislation

www.legislation.gov.uk/uksi/2004/1031/contents/made

Research Governance Framework

www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdf

Mental Capacity Act – Research Q&A

Mental Capacity Act 2005 QnA.pdf

Approving research under MCA section 34

www.hra.nhs.uk/documents/2013/09/section-34-approval-criteria.pdf

MRC ethics guides

Children

www.mrc.ac.uk/documents/pdf/medical-research-involving-children/

Informed Consent for Adults lacking capacity

www.mrc.ac.uk/documents/pdf/medical-research-involving-adults-who-cannot-consent/

Personal Information

www.mrc.ac.uk/documents/pdf/personal-information-in-medical-research/

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).