GLOSSARY OF COMMONLY USED TERMS
AE
Adverse Event: Any untoward medical occurrence in a subject to
whom a medicinal product has been administered, including
occurrences which are not necessarily caused by or related to that
product.
ADR
Adverse Drug Reaction: Any untoward and unintended response
in a subject to an investigational medicinal product which is
related to any dose administered to that subject.
ASR
Annual Safety Report
CA
Competent Authority
CFR
Code of Federal Regulations
CI
Chief Investigator: A Registered Physician, Dentist, Pharmacist or
Registered Nurse who has overall responsibility for the conduct of
the study.
CPD
Continuing Professional Development
CRF
Case Report Form
CRO
Clinical Research Organisation
CTA
Clinical Trial Authorisation
CTIMP
Clinical Trial with an Investigational Medicinal Product
DDX
Doctor’s and Dentist’s Exemption Scheme
DMC
Data Monitoring Committee
DRD
Director of Research and Development
EC
European Commission
Elective (training)
Training which is optional, that is available to any employees and
any other staff involved in clinical trials, but is not compulsory.
EMEA
European Medicines Agency
EU
European Union
EUCTD
European Union Clinical Trials Directive
EudraCT
European Clinical Trials Database
EudraVIGILANCE
European Database for Pharmacovigilance
FHD
First Human Dose
GLOSSARY OF COMMONLY USED TERMS
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice
GP
General Practitioner
GSTFT
Guy’s and St. Thomas’ NHS Foundation Trust
IB
Investigator’s Brochure
IC
Informed Consent
ICH
International Conference on Harmonisation
ICTR
Integrated Clinical Trial Report
IMP
Investigational Medicinal Product
IMPD
Investigational Medicinal Product Dossier
ISRCTN
International Standard Randomised Controlled Trial Number
JCTO
Joint Clinical Trials Office
KCH
Kings College Hospital NHS Foundation Trust
KCL
Kings College London
MA
Marketing Authorisation
Mandatory (training)
Training which must be completed by all employees and any other
staff involved in clinical trials and is therefore compulsory.
MHRA
Medicines and Healthcare products Regulatory Agency: UK
Competent Authority responsible for regulation of clinical trials.
MRC
Medical Research Council
MS
Member State
NHS R&D
National Health Service Research and Development Unit
NRES
National Research Ethics Service
NHS
National Health Service
Participant
An individual who consents to take part in a clinical trial
PD
Pharmacodynamic (studies)
PI
Principal Investigator: A Registered Physician, Dentist, Pharmacist
or Registered Nurse who has responsibility for the research at a
local site where the study involves specified procedures requiring
site-specific assessment.
GLOSSARY OF COMMONLY USED TERMS
PK
Pharmacokinetic (studies)
POC
Proof of Concept (studies)
QA
Quality Assurance
QC
Quality Control
QP
Qualified Person responsible for release of trial drug [Pharmacy]
RCT
Randomised Controlled Trial
Main REC
Main Research Ethics Committee: The REC that undertakes the
review of the research protocol, including the content of the
patient information sheet and consent form rather than just site
specific approval for each centre.
SAE
Serious Adverse Event: A serious adverse event is defined as an
adverse experience that results in any of the following outcomes:•
death;
•
a life-threatening adverse experience (any adverse
experience that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it
occurred, i.e., it does not include a reaction that, had it occurred
in a more severe form, might have caused death);
•
inpatient hospitalisation or prolongation of existing
hospitalization;
•
a
persistent
or
significant
disability/incapacity
(a
substantial disruption of a person's ability to conduct normal life
functions)';
•
a congenital anomaly/birth defect.
SAR
Serious Adverse Reaction
SDV
Source Document Verification
SI
Statutory Instrument (1031 and amendment 1928)
SmPC
Summary of Product Characteristics
SOP
Standard Operating Procedure
SSA
Site Specific Assessment
SUSAR
Suspected Unexpected Serious Adverse Reaction: A Suspected
Unexpected Serious Adverse Reaction is a serious adverse drug
GLOSSARY OF COMMONLY USED TERMS
reaction, the nature and severity of which is not consistent with the
information about the medicinal product in question set out:•
in the case of a product with a marketing authorisation, in
the summary of product characteristics for that product.
•
in the case of any other investigational medicinal
product, in the investigator's brochure relating to the trial in
question.
TSC
Trial Steering Committee
The Regulations
Medicines for Human Use (Clinical Trial) Regulations 2004
transposed the EU Clinical Trials Directive into UK legislation, as
Statutory Instrument 2004 no 1031. This became effective on the
1st May 2004. An amendment to implement Directive 2005/28/EC
was made to the Regulations as Statutory Instrument 2006 no
1928.
JCTO
The Joint Clinical Trials Office: Established in 2006 by Kings
College London, Guy’s & St Thomas’ NHS Foundation Trust and
King’s College Hospital NHS Foundation Trust to provide a
streamlined approach for all aspects of trial administration.
Clinical Trial
Any investigation in human subjects, other than a noninterventional trial intended to discover or verify the clinical,
pharmacological or other pharmacodynamic effects of one or
more medicinal product or to identify any adverse reactions to one
or more such products and to study absorption, distribution
metabolism and excretion in one of more such products with the
object of ascertaining the safety or efficacy of those products.
Partner Organisations
King’s College London, Guy’s & St Thomas’ NHS Foundation
Trust and King’s College Hospital NHS Foundation Trust.
GLOSSARY OF COMMONLY USED TERMS
Sponsor
Organization(s)
who
takes
responsibility for
the
initiation,
management and financing (or arranging the financing) of a
medicinal clinical trial (defined in the Regulations).
UADR
Unexpected Adverse Drug Reaction - An adverse drug reaction
the nature and severity of which is not consistent with the
information about the medicinal product in question set out :–
•
in the case of a product with a marketing authorization, in
the summary of product characteristics for that product,
•
in the case of any other investigational medicinal product,
in the investigator's brochure relating to the trial in
question.