Portsmouth Hospitals University NHS Trust works in close collaboration with external partners to further Research and Innovation, including the University of Portsmouth, the National Institute for Health Research and the Wessex Clinical Research Network (CRN).

The Portsmouth Technologies Trials Unit (PTTU) also works in collaboration with clinical researchers, academics, patients and commercial partners to develop research studies relevant to our community.

It specialises in working with commercial partners, including SMEs to develop research trials in new health care technologies and also has a broad portfolio of studies including observational studies and qualitative research. To find out more visit http://portsmouthtechnologiestrialsunit.org.uk/ 

Before starting a project, it is important to determine whether a project is classified as research, service evaluation or an audit. 


What is research?

Research generates new knowledge where there is no or limited evidence available and has the potential to be generalisable or transferable. 

Generalisable means the findings can be reliably extrapolated from the study to a broader population of patients or service users and/or applied to settings or contexts other than those in which they were tested.  

Transferable means the findings of a qualitative study can be assumed to be applicable to a similar context or setting. Although qualitative studies are not usually generalisable, they can often be transferable. 

If you are unsure if your project is research, please speak to the research coordinator in your area for advice or email research.office@porthosp.nhs.uk  

You can also refer to HRA decision tools: http://www.hra-decisiontools.org.uk/research/index.html 

Research will normally require Research Ethics Committee (REC) approval. Please refer to the HRA decision tools to confirm if ethics is required for your project: http://hra-decisiontools.org.uk/ethics/  

If you would wish to carry out a research study, please contact the Research Office by emailing research.office@porthosp.nhs.uk or get in touch with your department lead.

What is service evaluation?

Service evaluation is designed to examine how standard care is delivered with the intention of generating information to inform local decision-making.

If you are planning to carry out a service evaluation, please complete a proposal form and send to research.office@porthosp.nhs.uk

The Research Office will review your proposal to ensure it meets the criteria for service evaluation and will issue a confirmation letter. 


What is an audit?

An audit measures existing practice against evidence-based clinical standards.

For audit queries, please contact the Clinical Audit department - clinical.audit@porthosp.nhs.uk

Ref SOP title Version and date Associated docs


SOP for the Development, Management & Control of Research Related SOPs

V2.0, 29 Mar 2023

SOP Template, V2.1, 02 Sep 2020


SOP for Reporting and Managing Non-Compliance and Serious Breaches in Clinical Research

V4.0, 10 Jan 2024

Study Breach Record and Reporting Form


SOP for the Monitoring of Research Studies Sponsored by PHU

V2.0, 16 Dec 2019



SOP Recruiting and Consenting Patients into Clinical Research

V3.0, 13 Aug 2020

Delegation of Consent Form, V1.0, 8 May 2012

Delegation of Consent Form- CTA Informed Consent in Research

Delegation of Consent Form- CTIMP


SOP for Reporting Urgent Safety Measures in Clinical Research

V3.0, 7 Aug 2023



SOP Recording, Assessing & Reporting Adverse Events in Clinical Research

V3.0, 24 Apr 2023



SOP for Establishing and Maintaining a Trial Master File (TMF)/Investigator Site File (ISF)

V2.1, 28 Sept 2023



SOP for Preparation and Procedure to Archive

V2.0, 6 Nov 2023



SOP for Delegation of Roles and Responsibilities

V2/0, 14 Nov 2023



SOP Data Management of Research Studies at PHU

V2.0, 4 Nov 2020



SOP for Randomisation and Blinding for Randomised Controlled Trials

V1.0, 26 Apr 2016



SOP for Protocol Development

V1.0, 26 Apr 2016



SOP Management of Amendments in PHU Sponsored Studies

V3.0, 25 Sept 2023



SOP Creation of Crib/Work Sheets for Data Collection

V2.1, 20 Nov 2023



SOP for the Risk Assessment of Studies Sponsored by PHU

V1.0, 16 Dec 2019



SOP for Developing a Monitoring Plan for Studies Sponsored by PHU

V1.0, 16 Dec 2019



SOP for the Initiation and Management of Corrective and Preventative Action Plans (CAPA) for Studies Sponsored by PHU

V1.0 16 Dec 2019



SOP Remote Monitoring Visits of Research Studies at PHU

V1.1, 05 Dec 2023

Remote Monitoring Training Log, V1.0, 02 Sep 2020


SOP Preparation and Administration of Investigational Vaccines (Intramuscular) in the Portsmouth Research Hub

V1.0, 03 Nov 2022



SOP for the Recording of Research Study Information in Patient Records

V1.1, 29 Sept 2023

Template Documentation of Consent Record Sheet, V1.0


SOP Handling dry ice in the Portsmouth Research Hub

V1.0, 12 Mar 2024

Version 1.0