Glossary

Clinical Research - can be classified as either health and social care research or clinical trials.

Clinical Trial - research studies that test medical, surgical, or behavioural intervention in people, and conducted in specialist clinical trial units.

Health and Social Care Research - any health or social care related research that involves humans, their tissue and/or data. It is often conducted in public services such as the NHS or social care settings, but that is not always the case.

Research Governance - is an important part of Clinical Research and applies to everyone connected to it, whether as a chief investigator, care professional, researcher, their employer(s) or support staff. Research governance is needed to; safeguard participants in research, protect researchers/investigators (by providing a clear framework within which to work), enhance ethical and scientific quality, mitigate risk, monitor practice and performance, promote good practice and ensure that lessons are learned.

Sponsor - The role of the sponsor is to ensure health and social care research projects are legally compliant with regulatory processes so that high quality reputable research output is achieved. There are also similar legal requirements for other clinical research to have a sponsor, such as clinical trials of medicinal products or medical devices. For non-commercial research, the sponsor is usually the substantive employer of the researcher leading the project, or in cases of student researchers, the institution where the student is registered.

Acronyms

• ACP – Advanced Clinical Practitioners
• ALCOAC – Attributable Legible Contemporaneous Original Accurate Complete
• CA – Competent Authority
• CAG – Confidential Advisory Group
• CAPA – Corrective and Preventative Action
• CE - Conformité Européenne
• CRF - Case Report Form
• CRGO - Clinical Research Governance Officer
• CRN – Clinical Research Network
• CTIMP – Clinical Trial of an Investigational Medicinal Product
• e-ISF - Electronic Investigator Site Files
• EMA – European Medicines Agency
• e-TMF - Electronic Trial Master Files
• EudraCT – European Clinical Trials Database
• GCP – Good Clinical Practice
• GDPR – EU General Data Protection Regulation
• HRA – Health Research Authority
• HSCRSC – Health and Social Care Research Sponsorship Committee
• IB - Investigator Brochure
• ICMJE – International Committee of Medical Journal Editors
• IG – Information Governance
• IMP – Investigational Medicinal Product
• IRAS – Integrated Research Application System
• ISF – Investigators Site File
• ISRCTN – International Standard Randomised Controlled Trial Number Register
• MHRA – Medicines and Healthcare Products Regulatory Agency
• ND – Not done
• NIHR – National Institute for Health and Care Research
• NK – Not known
• PIS – Patient Information Sheet
• PPI – Public Patient Involvement
• RDO – Research Development Officer
• REAMS – Research Ethics Application Management System
• REC – Research Ethics Committee
• RSI - Reference Safety Information
• SAE – Serious Adverse Event
• SDV – Source Data Verification
• SmPC - Summary of Product Characteristics
• SUSAR - Suspected Unexpected Serious Adverse Reaction
• TMF – Trial Master File
• UREIC – University Research Ethics and Integrity Committee

Frequently Asked Questions

What approvals do I need for my health and social care research project?

Please refer to this area of our webpages Identifying the Approvals...and use the decision tools held within.

How do I apply for sponsorship?

Please refer to this area of our webpages Making Your Applications and follow the guidance held within.

How do I complete my IRAS form?

Standard answers for completing the IRAS form can be found on our webpages here HRA Approval and...under the tab 'Lancaster University Specific IRAS Application Guidance'.

Who is the Sponsor Representative for listing on the IRAS form?

Sponsor Representative details for the IRAS form can be found on our webpages here HRA Approval and...under the tab 'Lancaster University Specific IRAS Application Guidance', Sections A4 & A64.

Do I need an OID or Model Agreement?

Where do I find forms and other documents that I might need?

This area of our webpage Forms and Templates contains links to all of our guidance documents, flow charts, standard operating procedures, forms and templates.

My study has reached the end point as defined in the protocol, how do I close my study?

We have a dedicated webpage which details everything you need to know and do to declare the end of you study End of Study.

Part of declaring the end of my study involved the submission of a lay summary to the Clinical Research Governance team, where is this published?

All lay summaries are published on our lay summary webpage Lay Summaries