Commonly Used Research Abbreviations and Terms

Contents

Commonly Used Research Abbreviations and Terms

ABPI

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

AE

Adverse Event Amendment A written description of a change to the protocol or supporting documents. All amendments should be submitted to HRA for ongoing HRA Approval.

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.

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.

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.

CCF

NIHR Central Commissioning Facility. The CCF manages the following research funding programmes.

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 multisite 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.

(ii) Coordinating investigator

CPMS

Central Portfolio Management System: a national system that will enable the NIHR CRN to capture high quality study information and produce a range of detailed reports to help manage and deliver studies. CPMS will replace the Portfolio Database, Industry Application Gateway and interim Industry Tracker.

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 Form

Data collection tools provided by a sponsor on which the clinical data is recorded for each participant, such as weight, lab results, symptoms.

(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 (no longer in use, see HRA Approval).

CTA

(i) Clinical Trials Administrator

Person providing coordinating/secretarial support for running clinical studies.

(ii) Clinical Trials Agreement

Contract between the legal Sponsor and the hosting research sites.

(iii) Clinical Trials Associate

(Similar to CRA). Person involved in the management of a study from initiation, through conduct/monitoring to close-out.

(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.

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.

DH

Department of Health (for England).

DPA

Data Protection Act.

DQ

Data query.

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.

DSUR

Development Safety Update Report: In addition to the expedited reporting required for SUSARs, Sponsors are required to submit a safety report (DSUR) to the MHRA and Research Ethics Committee, once a year throughout the clinical trial or on request.

ECMC

Experimental Cancer Medicine Centre.

eCRF

An electronic CRF.

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.

EPAP

European Patient Ambassador Programme.

eTMF

An electronically stored TMF.

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.

FDA

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

Feasibility

The process of reviewing the protocol to determine whether or not a study can be safely and effectively delivered.

GAfREC

Governance Arrangements for Research Ethics Committees.

GCP

Good Clinical Practice: GCP is an international ethical and scientific quality standard for designing, recording and reporting studies. The aim of GCP is to ensure the rights, safety and wellbeing of study participants are protected and research data is high quality.

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.

HRA

Health Research Authority.

HRA Approval

The process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

HRC

Honorary Research Contract.

HSE

Health and Safety Executive.

HTA

(i) Human Tissue Act / Human Tissue Authority

(ii) Health Technology Assessment

One of the NIHR research funding streams.

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. Section E6 of ICH defines principles of Good Clinical Practice (referred to as ICH-GCP).

IDMC

Independent Data Monitoring Committee.

IMP

Investigational Medicinal Product: an unlicensed new drug, an existing drug tested outside its licence, or existing drugs tested against each other for their efficacy/safety. The MHRA provide advice to help you decide if your product is an investigational medicinal product (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.

LCRN

Local Clinical Research Network.

LPMS

Local Portfolio Management System: local systems which capture high quality study information and integrate with CPMS.

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).

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.

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.

ND

Not done (in CRFs).

NHS

National Health Service.

NICE

National Institute for health and Clinical Excellence: develop evidence-based guidelines on the most effective ways to diagnose, treat and prevent disease and ill health.

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

National Institute for Health Research Clinical Research Network.

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 (in CRFs).

NOCRI

National Office for Clinical Research Infrastructure.

Nonsubstantial 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).

NRES

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

ODP

Open Data Platform: an online, open platform which provides secure access to collated study and recruitment data.

PI

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

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.

PPIE (or PPI)

Patient and Public Involvement and Engagement.

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).

SAE

Serious Adverse Event.

SAR

Serious Adverse Reaction.

Screening

The process of identifying eligible patients prior to approaching them to determine if they are willing to consent to participate in the study.

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.

SI

(i) Statutory Instruments

Document which defines UK law in on a specific topic, e.g. how to manage a clinical trial SI.

(ii) 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.

SIV

Site initiation visit.

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.

Substantial Amendment

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 safety or physical or mental integrity of the participants or the scientific value of the trial.

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.

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.