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Frequently Asked Questions (FAQ) & Glossary

What is a clinical trial?   

 A clinical trial is also known as a medical research study. It is a carefully designed test of medicines and treatment options under the supervision of a doctor

What is the aim of a clinical trial?

 A clinical trial is a particular type of clinical research study that compares one treatment with another. It may involve patients or healthy people, or both. 

Why are clinical trials important?

Doctors and other health professionals and patients need evidence from clinical trials to know which treatments work best. Without this evidence, there is a risk that people could be given treatments that have no advantage, that waste NHS resources and that might even be harmful.

Therefore, clinical trials find out:

  • if treatments are safe
  • if treatments have any side effects
  • if new treatments are better than available standard treatments

Clinical trials can help to:

  • prevent illnesses by testing a vaccine
  • detect or diagnose illnesses by testing a scan or blood test
  • treat illnesses by testing a new medicine
  • provide treatments in the best way for finding out how best to help people with their illness
  • help people control their illness or improve their quality of life by testing how a particular diet affects a condition

Who can participate in clinical trials?

Clinical trials rely on people, referred to as study participants, to try the new medicine or treatment. Any participation is voluntary.  Each clinical trial defines who is eligible to take part in the study and must include only people who fit the patient traits for that study (the eligibility criteria). Some trials enrol people who have a specific disease or condition. Others enrol healthy people to test new approaches to prevention, diagnosis or screening.

How are clinical trials different from standard clinical care?  

If you take part in a clinical trial, you will still have tests or treatments in a hospital, clinic or doctor's office. However, you may have more tests and medical exams than you would otherwise.

How are clinical trials regulated? 

Every study participant is closely monitored with medical tests and examinations before, during and after the clinical trial.  In addition, clinical trials must follow strict rules set by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health.  Each trial must be approved by an Ethics Committee (EC) in the UK. An EC is an independent committee of healthcare professionals and non-medical members. Before the study goes ahead, the EC makes sure that it is ethical and that the highest standards of safety will be maintained.

What are Phase I, Phase II and Phase III studies? 

The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects. 

The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study. 

The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.  

What is a placebo? 

Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.

How can I get involved?  You can look for research studies yourself, by asking your doctor or a patient organisation, or by looking on the internet (such as on the UK Clinical Trials Gateway). Alternatively, you may be approached to take part in research.

What is a research Sponsor?

The Sponsor is the organisation that takes on responsibility for confirming there are appropriate arrangements to initiate, manage and monitor, and finance a study. For any research that takes place in the context of the NHS or Social Care services, it is necessary that a Sponsor is identified. The Sponsor is normally expected to be the lead employer of the research team, the lead health or social care organisation, or the main funder.  If you would like Derby Teaching Hospitals NHS Foundation Trust to be the Sponsor of your research please click here.

Main responsibilities:  The Sponsor has the responsibility for ensuring that all the necessary arrangements are in place before the study can proceed, including:

  • ensuring that the research study has obtained scientific quality approval from the necessary bodies,
  • ensuring that the study has obtained ethical approval,
  • ensuring arrangements are in place for the monitoring and reporting of research,
  • ensuring the research team have access to resources and support to deliver the research as proposed.

 

Who can be Chief Investigator? 

A senior individual must be designated as the Chief Investigator for any research undertaken in or through the NHS or social services, which involves participants or their organs, tissue or data.

Main responsibilities:  The Chief Investigator is the individual who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the Chief Investigator takes responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the lead at each site

Who can be Principal Investigator?  

The Principal Investigator is the person responsible individually, or as the leader of researchers at a particular site, for the conduct of a study.

Main responsibilities of the Principal Investigator are to:

  • submit proposals for ethical review,
  • obtain Sponsorship approval,
  • conduct research according to agreed protocol & in accordance with legal requirements,
  • ensure participant welfare,
  • ensure accurate record keeping,
  • report adverse events.

 

How is research funded?  

Research that takes place in the NHS may be paid for by one of a variety of different organisations, and often more than one working in partnership. More information about funding you can find in our funding pages.

What is GCP? 

The tripartite harmonised ICH Guideline was finalised under Step 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.

What is Research Governance?  

Research Governance can be defined as the broad range of regulations, principles and standards of good practice that exist to ensure the highest standards of quality research. This covers scientific quality, ethical standards and all aspects of research management.

What is a CTIMP?  

Clinical Trial of an Investigational Medicinal Product (CTIMP) is a study that looks at the safety or efficacy of a medicine/foodstuff/placebo in humans, as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe

What is the purpose of the NIHR Clinical Research Networks? 

The purpose of the NIHR Clinical Research Network (NIHR CRN) is to provide a world-class health service infrastructure to support clinical research in the NHS in England and to enable research to be conducted across the full spectrum of disease and clinical need. The CRN comprises of 15 Local Clinical Research Networks (LCRN) that cover the length and breadth of England. Each LCRN supports the delivery of NIHR CRN Portfolio studies across 30 clinical specialties. You can read more about the CRN East Midlands here.

What is the purpose of the NIHR Clinical Research Networks?

The purpose of the NIHR Clinical Research Network (NIHR CRN) is to provide a world-class health service infrastructure to support clinical research in the NHS in England and to enable research to be conducted across the full spectrum of disease and clinical need. The CRN comprises of 15 Local Clinical Research Networks (LCRN) that cover the length and breadth of England. Each LCRN supports the delivery of NIHR CRN Portfolio studies across 30 clinical specialties.

What are our set-up timelines? 

Derby Teaching Hospitals NHS FT works towards achieving the NIHR 40 day target from valid research application to confirmation of participation.

What is our contract review process?

TheDHFT R&D Office reviews study contracts immediately after a study is deemed feasible, aiming to meet to the Sponsors target date for study set-up.  

ABPI

Association of the British Pharmaceutical Industry: A trade association for UK pharmaceutical companies

ADR

Adverse Drug Reaction (also known as AR)

AE

Adverse Event

Amendment

A written description of a change or formal clarification. Substantial amendments (See below under ‘Substantial Amendment’) to protocol, participant information/consent require REC, R&D, MHRA approval, Non-substantial amendments should be ‘notified’ to REC, R&D, MHRA

AMRC

Association of Medical Research Charities

AR

Adverse Reaction (also known as ADR)

ARSAC

Administration of Radioactive Substances Advisory Committee: Research studies wishing to administer radioactive medicinal products to human subjects need to obtain ARSAC approval before NHS R&D approval

ASR

Annual Safety Report: For studies involving the use of an Investigational Medicinal Product, this is the annual report which must be submitted to the MHRA detailing all SUSARs and SARs that have occurred in subjects on that study in the past year

ATMP

Advanced Therapy Medicinal Products

BP

Blood pressure

BRC

Biomedical Research Centre: larger centre covering a number of topcs with facilities and research active clinicians/academics/research nurses to run clinical projects

BRU

Biomedical Research Unit: topic-focused centre which usually combines facilities and research active clinicians/academics/research nurses to run clinical projects, e.g. respiratory BRU

C/O

Complains of

CA

Competent Authority: organisation approving the testing of new drugs/devices or approving the marketing licences, in the UK this is the MHRA

CC

Coordinating Centre

CCRN

Comprehensive Clinical Research Network

CF

Consent Form (also ICF, Informed Consent Form)

CFR

Code of Federal Regulations (US)

CI (i)

Chief Investigator: The lead investigator with overall responsibility for the research. In a multi-site study, the CI has coordinating responsibility for research at all sites. The CI may also be the PI at the site in which they work. In the case of a single-site study, the CI and the PI will normally be the same person and are referred to as PI.

CI (ii)

Coordinating investigator

CLRN

Comprehensive Local Research Network: CLRNs are the primary vehicle for providing infrastructure to support study involvement at local NHS Trusts. There are 25 in England.

COREC

 Central Office for Research Ethics Committees (replaced in 2007 by NRES)

CRA

Clinical Research Associate: usually a commercially employed person supporting the management of clinical studies, helps with obtaining R&D approval, site initiation, study monitoring and close out

CRF (i)

Case Report Forms: data collection tools provided by a sponsor on which the clinical data is recorded for each participant, such as weight, lab results, symptoms

CRF (ii)

Clinical Research Facility: hospital-like facility with consulting rooms, standard patient beds, ward medical equipment, research nurses supporting only research

CRN

Clinical Research Network

CRO

Clinical Research Organisation or Contract Research Organisation: A person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions

CSAG

Clinical Studies Advisory Group

CSG

 Clinical Studies Group

CSP

Coordinated System for gaining NHS Permissions: Standard process for adoption onto NIHR Portfolio of Studies in order to access NIHR CRN Support and funding; streamlines the process for gaining NHS permissions by collating the information for global and local approvals; researchers initiate this in IRAS by completing and submitting CSP Application Form

CTA (i)

Clinical Trials Administrator: person providing coordinating/secretarial support for running clinical studies

CTA (ii)

Clinical Trials Agreement: contract between the legal Sponsor and the hosting research sites

CTA (iii)

Clinical Trials Associate (similar to CRA): person involved in the management of a study from initiation, through conduct/monitoring to close-out

CTA (iv)

Clinical Trials Authorisation: The regulatory approval for a clinical trial of a medicinal product issued by the MHRA

CTAAC

Clinical Trials Advisory and Awards Committee

CTD

Clinical Trial Document

CTIMP

Clinical Trial of an Investigational Medicinal Product

CTU

Clinical Trials Unit: Design and manage CTIMPs, sometimes in specialist clinical areas, such as Cancer, or types of trial, such as RCTs

CV

 Curriculum Vitae

D&V

Diarrhoea and Vomiting

DeNDRoN

Dementias and Neurodegenerative Diseases Research Network

DH

Department of Health (for England)

DIPEx

Database of Individual Patient Experience – the DIPEx website has a range of open source videos of real patient experiences www.healthtalkonline.org

DNA

Did not attend

DPA

Data Protection Act

DQ

Data query

DRN

Diabetes Research Network

DSMB

Data and Safety Monitoring Board: An independent committee composed of clinical research experts and community representatives that reviews data whilst a clinical trial is in progress to ensure that participants are not being exposed to undue risk

ECG

Electrocardiogram

ECMC

Experimental Cancer Medicine Centre

EM

Experimental Medicine

EMA

The European Medicines Agency: A body of the European Union which has responsibility for the protection and promotion of public health through the evaluation and supervision of medicines for human use

EU

European Union

EudraCT

European Clinical Trials Database: A database of all clinical trails in Europe, held since 1994 in accordance with EU directive 2001/20/EC

FAQ

Frequently Asked Questions

FDA

Food and Drug Administration: the Competent Authority in the United States, giving authorisation to conduct clinical trials and issuing marketing licences

GAfREC

Governance Arrangements for Research Ethics Committees

GCP

Good Clinical Practice: A specific internationally recognised version of this is ICH-GCP (see below)

GLP

Good Laboratory Practice: standard for laboratories involved in pre-clinical analyses (e.g. animal, in vitro); does not apply to Laboratories analysing samples from clinical trials involving humans

GMP

Good Manufacturing Practice: quality assurance standard for producing IMP, medicinal products

GTAC

Gene Therapy Advisory Committee: the ethics committee for clinical studies using genetically modified products; usually no REC approval required

HEI

Higher Education Institution

HFEA

Human Fertilisation and Embryological Authority

HRC

Honorary Research Contract

HTA

Human Tissue Act or Human Tissue Authority

HTA

Health Technology Assessment – one of the NIHR research funding streams

IA

Incapacitated Adult

IB

Investigator’s Brochure: A compilation of clinical and pre-clinical pharmacological/biological data relevant to the use of that IMP(s) in human subjects (one single IB for all trials using the same IMP)

ICF

Informed Consent Form

ICH-GCP

International Conference on Harmonisation (Europe, USA, Japan): Defined standards for the terminology, design, conduct, monitoring, recording, analysis and reporting of a study. These standards give assurance that the reported results are accurate and credible and that the rights, integrity and confidentiality of all study participants have been protected throughout the study. Section E6 of ICH defines principles of Good Clinical Practice (referred to as ICH-GCP). Research teams on CTIMPs in the UK must follow GCP requirements as detailed in MfHU (CT) Statutory Instruments; all non-CTIMP studies conducted within the NHS adhere to GCP according to Research Governance Framework

IDMC

Independent Data Monitoring Committee

IMP

Investigational Medicinal Product: an unlicensed new drug, or an existing drug tested outside its licence, or existing drugs tested against each other for their efficacy/safety. The MHRA provide an algorithm to establish whether a study is a CTIMP: see Resource 2 or the MHRA webiste http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con009394.pdf

IND

Investigational New Drug: sometimes used instead of IMP

Indemnity

Compensation for damage, loss or injury

Investigator

Researcher conducting the (clinical) study, those researchers leading the team are referred to as CI or PI

IRAS

Integrated Research Application System: A single, web-based system for completing applications for the permissions and approvals required for health and social care research in the UK. The various applications can be printed or submitted for this single system (includes REC, R&D, MHRA, GTAC, NIGB, ARSAC)

IRB

Independent Review Boards: US equivalent of authorised REC

IRMER

Ionising Radiation Medical Exposure Regulations: part of NHS R&D approval, usually done by the local hospital experts

ISF

Investigator Site File: A file designed for use in organising and collating all essential documentation required to conduct a study in accordance with the principles of GCP and the applicable regulatory requirements (e.g. REC approval letter/correspondence, MHRA approval, blank CRF, staff CVs, delegation of duties log etc.)

ISRCTN

International Standard Randomised Control Trial Number: A simple numeric system for the identification of randomised controlled clinical trials worldwide. Allows the identification of trials and provides a unique number that can be used to track all publications and reports resulting from each trial; can be obtained from www.isrctn.org or www.controlledtrials.com/mrct

LRN

Local Research Network

MCA

Mental Capacity Act

mCIA

model Clinical Investigation Agreement: for medical devices, covers the running of the study, not design of prototype or design of protocol; standard template for the UK (use is not obligatory)

MCRN

Medicines for Children Research Network

mCTA

model Clinical Trial Agreement: for IMP studies with commercial sponsor/CRO conducted; standard template for the UK (use is not obligatory)

MfHU (CT)

Medicines for Human Use (Clinical Trials) Regulations: SI 2004:1031 and subsequent amendments 2006:1928, 2006:2984 ,2008:941, 2009:1164 and 2010:1882 are the UK Statutory Instruments translating EU directives 2001/20/EC and 2005/28/EC into UK law, laying down the legal requirements for conducting CTIMPs in the UK

MHRA

Medicines and Healthcare products Regulatory Agency: The UK Competent Authority (CA) and licensing authority for medicines and medical devices. It replaced both the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) in April 2003

MHRN

Mental Health Research Network

mNCA

model Non-Commercial Agreement: for clinical research studies; standard template for the UK (use is not obligatory)

Monitor

The person designated by the sponsor to perform site visits and conduct the monitoring process; eg check whether there are any deviations from the protocol and that all source data was transferred into the Case Report Forms correctly

MRC

Medical Research Council

Multi Centre Study

A study conducted according to a single protocol but carried out at more than one site and by more than one investigator; one CI oversees several local PIs

NCRN

National Cancer Research Network

ND

Not done

NHS

National Health Service

NICE

National Institute for health and Clinical Excellence (decides which drugs are accepted into NHS treatment)

NIGB

National Information Governance Board for Health and Social Care Ethics and Confidentiality Committee (NIGB HSC ECC): formerly PIAG, gives approval for projects using patient data without obtaining consent

NIHR

National Institute for Health Research: established by Department of Health for England in 2006 to provide the framework through which DH will position, manage and maintain the research, research staff and infrastructure of the NHS in England as a virtual national research facility

NIHR CRN CC

National Institute for Health Research Clinical Research Network Coordinating Centre

NIHR IS

National Institute of Health Research Information Systems

NIMP (or non-IMP)

Non-Investigational Medicinal Product: product used alongside IMP but not directly under investigation in the research study, e.g. a challenge agent

NK

Not known

NOCRI

National Office for Clinical Research Infrastructure

Non-substantial amendments

Changes to the details of a study that have no significant implications for the subjects, the conduct, the management or the scientific value of the study (sometimes referred to as administrative amendments). Examples may be as follows:

  • Correction of typographical errors in the protocol or other study documentation
  • Amended contact details for the sponsor or project staff
  • Changes in funding arrangements
  • Appointment of new support staff
  • Changes in the documentation used to record study data
  • Changes in the logistical arrangements for transporting or storing samples

 

NRES

National Research Ethics Service: umbrella organisation responsible for all REC across the UK (replaced COREC in 2007)

OSCHR

The Office for Strategic Coordination of Health Research (UK wide)

PCF

Patient/Participant Consent Form

PCRN

Primary Care Research Network

PCT

Primary Care Trust

PI

Principal Investigator: The lead person at a single site designated as taking responsibility within the research team for the conduct of the study

PIAG

Patient Information Advisory Group (now NIGB)

PIC

Participant Identification Centre: NHS or other organisation which only identifies participants from a database etc, but recruitment/receiving consent and study conduct are managed elsewhere

PIS

Participant or Patient Information Sheet: An information leaflet given to those who have been invited to participate in a research study. The sheet is designed to provide the potential participant with sufficient information to allow that person to make an informed decision on whether or not they want to take part

PPI

 

Patient and Public Involvement

QA

Quality Assurance

QC

Quality Control

QLQ

Quality of Life Questionnaire

R&D

Research and Development: often name of Department within NHS hospitals giving permission to conduct projects on those facilities with patients/staff

RCT

Randomised Controlled Trial: A randomised controlled trial (RCT) is a clinical study in which two (or more) forms of care are compared; the participants are allocated to one of the forms of care in the study, in an unbiased way

RDS

Research Design Service: organisation with a number of experts who can help write the protocol/documents for NIHR grant applications

REC

Research Ethics Committee: authorised by NRES to review study documents for research taking place in the NHS, or social services. Some REC specialise in Clinical Trials, or topics such as research in children, MCA. See NRES website for more detail and other types of research http://www.nres.npsa.nhs.uk/ All Research in NHS/social services must have been reviewed by a UK REC

Research Passport

A system for HEI employed researchers/postgraduate students who need to undertake their research within NHS organisations, which provides evidence of the pre-engagement checks undertaken on that person in line with NHS Employment Check Standards (among them CRB and occupational health checks)

RfPB

Research for Patient Benefit: NIHR research funding stream

RGF

Research Governance Framework: DH guidance for the conduct of research within the NHS in England (use 2nd edition, 2005)

RM&G

Research Management and Governance

SAE

Serious Adverse Event

SAR

Serious Adverse Reaction

SDV

Source Data Verification: checking the original data record, such as lab reports, patient medical notes against what was transferred onto the CRF/into a database

Serious-ADR

Adverse drug reaction which falls in to one of the serious criteria and therefore warrants expedited reporting (serious = resulting in hospitalisation, prolonged hospitalisation, death, life-threatening, congenital anomaly/birth defect or persistent or significant disability/incapacity)

SHA

Strategic Health Authority

SI

Statutory Instruments: document which defines UK law in on a specific topic, e.g. how to manage a clinical trial

SI

Sub-Investigator (as in ICH-GCP, ICH does not use the term Co-investigator)

Site

The NHS organisation in which study activities and assessment are performed or the location(s) where trial-related activities are actually conducted. Each site/Trust needs to give R&D approval

SLA

Service Level Agreement

SMO

Site Management Organisation

SmPC

Summary of Product Characteristics: smaller version of Investigator Brochure with details on pharmacological effects, side effects, but issued for a product that already holds a marketing licence

SOP

Standard Operating Procedure: detailed written instructions designed to achieve uniformity of the performance of a specific function

SRN

Stroke Research Network

SSA

Site Specific Assessment: An assessment performed to establish the suitability of a Principal Investigator and a site for the conduct of research; SSA will be performed by the Participating CLRN for each research site (NHS organisation), using an SSI form available in IRAS

SSI

Site Specific Information: local detail to inform SSA including qualifications/expertise of the PI and wider research team, study procedures, departmental capacity to absorb project (includes Pharmacy, Pathology, Radiology) and departmental leads signatures; The SSI form is completed in IRAS

Substantial Amendment

A substantial amendment can be defined as an amendment to the protocol or any other study specific documentation, the terms of the REC application or the terms of the CTA application (as applicable) that is likely to affect to a significant degree the:

  • The safety or physical or mental integrity of the subjects of the trial; 
  • The scientific value of the trial; 
  • The conduct or management of the trial; or 
  • The quality or safety of any investigational medicinal product used in the trial.

Other changes to the particulars of a study that qualify as substantial amendments include: 

  • A change of sponsor(s) 
  • Appointment of a new Chief Investigator and 
  • Extension of the research beyond the planned closing date for recruitment

 

A substantial amendment may not be made to a research study without the favourable opinion from the REC that gave a favourable opinion for the study (the main REC) and as applicable the MHRA. The only exceptions to this rule are:

  • The Inclusion of a new research site or 
  • The Appointment of a new PI at an individual site

 

Both of these qualify as substantial amendments but as they require further SSA and approval from the REC there is no requirement for notice of amendment to the REC. These changes do still however need to be notified to the MHRA (as applicable)

SUSAR

Suspected Unexpected Serious Adverse Reaction: A Serious Adverse Reaction (SAR) which is Unexpected (i.e. its nature and severity is not consistent with the known information about that product from the Investigator’s Brochure or the SmPC) and suspected, as it is not possible to be certain of causal relationship with the IMP

TCRN

Topic specific Clinical Research Network: includes DRN, DeNDRoN, NCRN, MCRN, MHRN and SRN

TMF

Trial Master File (file with essential documents held by the Chief Investigator/Sponsor organisation)

UKCRC

United Kingdom Clinical Research Collaboration

WHO

World Health Organisation

WMA

World Medical Association

WT

Weight


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