For Researchers

************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************

The R&I team aim to provide a comprehensive support service throughout the duration of the project from inception to submission of final report. With this in mind, it is important that you contact the appropriate R&I portfolio team as early as possible.

New academic studies (including student projects): please provide a brief summary of the background to the study along with a draft protocol.

Ongoing academic studies at other sites: if you would like to participate in a study sponsored by another Board or Trust, please provide a copy of the current study protocol and contact details of the study Co-ordinator.

Researchers should be aware there is a separate research review process for projects requiring access to social work service users, social work staff or social work data in relation to social care and community health services falling under Glasgow City Health and Social Care Partnership, further information available here.

This website contains a practical guide to help you navigate the R&I process and highlights key steps required to get your research project up and running. Please refer to this f low diagram for additional information on specific aspects of your R&I application.

Is your project research?

Research is defined as: ‘..an attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’ As R&I approval is required for all research studies it is important to know if your project can be classed as research or not.

Research must be systematic and follow a series of predefined steps defined in a protocol
Research must be well organised and undergo rigorous planning, including performing an in-depth literature review and evaluation of questions to be answered
The scientific definition of research generally states that a variable must be manipulated, although case studies and purely observational science do not always comply with this.

This table should help you decide if your project is research. Should you be unsure, please do not hesitate to contact the R&I office who will be happy to advise. For projects classed as clinical audit or service evaluation, the clinical effectiveness team can provide specialist support and advice.

Data Handling Measures

Interim data handling procedures can be found here

Developing your protocol

Study protocols, patient information leaflets and patient consent forms should be prepared in standard templates (below) and should be date and version controlled.

When developing your protocol click here for a few key elements that you should consider

Once you have developed a full draft of your Protocol, Patient Information Sheets, Consent Forms and IRAS forms you should ask your Research Co-ordinator to review and provide some comments. Co-ordinators can advise on the level of detail required in each of the documents and can check for consistency between them.

Identify a sponsor

The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage, monitor and finance a study. For any health research study covered by the Research Governance Framework, it is for the sponsor to be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing. For any research that takes place in the context of the NHS in Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for particular aspects of the arrangements for the study. The sponsor may be the Chief Investigator’s employing organisation, the lead organisation providing healthcare, or the main funder. NHS GG&C can act as sponsor in the following situations:

A study where the CI is an NHS GG&C employee
A study involving NHS GG&C patients, staff or resources.

For more information on study sponsorship, please contact your Research Co‑ordinator.

Clinical Trials

For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution, company or organisation) who takes responsibility for the initiation management and financing (or arranging the financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials) Regulations 2004. Following appropriate risk assessment, NHS GG&G may act as sponsor on a trial where the Chief Investigator is an employee of NHS GG&C. Where the Chief Investigator is an employee of the University of Glasgow, NHS GG&C and the University may act as co-sponsor. Clinical trials sponsored by NHS GG&C should be formally adopted by and run by standards outlined by the Glasgow Clinical Trials Unit (CTU) standard operating procedures (SOPs).

Will your study generate intellectual property?

The Greater Glasgow Health Board Policy on the Management of Intellectual Property can be found here

Pharmacovigilance

Pharmacovigilance ensures the safety, quality and efficacy of medicines and healthcare products. The Scottish Executive Health Department Research Governance Framework for Health and Community Care (Second Edition, 2006) further defines the responsibilities in clinical trials and in other research carried out in Scotland. In CTIMPs sponsored by NHS Greater Glasgow and Clyde or co-sponsored with the University of Glasgow, the delivery of pharmacovigilance activity within the CTIMP is delegated to the Chief Investigator (CI). However, the ultimate responsibility and accountability for pharmacovigilance remains with the sponsor. The Pharmacovigilance Office facilitates and ensures compliance with this responsibility and provides central coordination of pharmacovigilance activity within the Glasgow Clinical Trials Unit.

Pharmacovigilance Office

Glasgow Clinical Trials Unit Robertson

Centre for Biostatistics

Boyd Orr Building

University of Glasgow

Glasgow G12 8QQ

Tel: +44(0)141 330 4744

Fax: +44(0)141 357 5588

Web: Can be accessed here

Pharmacovigilance Enquiries: pharmacovig@glasgowctu.org

Research facing primary care

A useful guide to research in a Primary Care setting is available here.

Good clinical practice

All researchers are required to adhere to the relevant legislation, frameworks and principles and take responsibility for ensuring any staff and students involved in research are familiar with the appropriate requirements. To achieve working to this level, the Good Clinical Practice Training for Staff Involved in Clinical Research policy outlines the expectation for staff and students to attend Good Clinical Practice (GCP) training, which is integral to the research experience and culture within NHS GG&C. Each person involved in a clinical trial must receive training in GCP appropriate to their roles and responsibilities.

The NHS GG&C Good Clinical Practice Training for Staff Involved in Clinical Research policy document is available here.

To book a GCP course (1/2 day or full day) please follow the links below:

Published information data transparency

Document is available here

Research activity confirmation

We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).

Further information is available on the Research activity confirmation page

Managed recovery process

A National process is currently underway to identify interventional, multi-site clinical research studies that are both urgent and should benefit from the support of NIHR CRN, NHS research Scotland, and R&I to fully recruit and/or close in the next year. Chief Investigators will be contacted directly if their projects have been selected by the funder for the managed recovery process. There is no intention that this process will result in any pause or withdrawal of support for studies active within NHS GG&C.

(https://www.nihr.ac.uk/documents/guidance-on-the-managed-recovery-of-the-uk-clinical-research-portfolio/27749 _

Since July 2020, NHS GG&C have initiated a local process for restarting all studies paused due to COVID-19. Locally, work continues to ensure that all studies are able to return to normal recruitment activities. In addition to local efforts and participating in the UK Managed Recovery Process we will continue to prioritise (please note the order does not indicate priority levels):

NHS GGC locally sponsored/co-sponsored studies and in particular those involving early career researchers who have limited time to complete their funded clinical research.
Studies that include routine standard of care as an option
On going “urgent public health COVID-19” studies (e.g., Oxford-Astra/Zeneca, Novavax, Valneva and COV-BOOST vaccine trials; OCTAVE and SIREN etc)