ADR - adverse drug reaction
all noxious and unintended responses to a medicinal product related to any dose
AE - adverse event
any untoward medical occurrence in a patient which does not necessarily have to have a causal relationship
with this treatment
AMG - Arzneimittelgesetz
German drug law
BfArM - Bundesanstalt für Arzneimittel und Medizinprodukte
(Federal Institute for Drugs and Medical Devices)
German regulatory authority
CDER - Center for Drug Evaluation and Research
scientific body of the FDA
CDISC - Clinical Data Interchange Standards Consortium
organisation for development of standards for data exchange to be used for regulatory applications as well
as for exchanges between pharmaceutical companies and CROs
CIOMS - Council for International Organisations of Medical Sciences
international, non-governmental, non-profit organisation established jointly by WHO and UNESCO
CPMP - Committee for Proprietary Medicinal Products
EMEA committee responsible for medicines for human use
CRA - clinical research associate
individual that oversees the progress and conduct of a clinical trial (sometimes also called "monitor")
CRF - case report form
a document designed to record all of the protocol required information to be reported to the sponsor
CRO - contract research organisation
an organisation contracted by the sponsor to perform one or more of a sponsor's trial-related duties
CRT - controlled clinical trial
"golden standard" for clinical design
CTC - clinical trial coordinator
person to assist administering the trial for all aspects of trial conduct
CTD - common technical document (ICH)
format of dossiers in a given format for applications that will be submitted to regulatory authorities
DMP - data management plan
document developed in advance to define methods for data management describing the database, data entry and
validation processes
EC - European Commission
executive organisation of the European Union
EDC - electronic data capture
ability to electronically capture case report forms and subject data directly from a site
EDQM - European Directorate for the Quality of Medicines
one of the directorates of the Council of Europe
EFPIA - European Federation of Pharmaceutical Industries and
Associations
EMEA - European Medicines Agency
(previously: "European Agency for the Evaluation of Medicinal Products" or " European Medicinal Evaluation
Agency")
decentralised body of the EU that coordinates scientific resources existing from EU member states to
evaluate, supervise and provide opinions on marketing authorisation of medicinal products for human or
veterinary use
EOF - (Greek) National Organization for Pharmaceuticals
Greek regulatory agency
EU - European Union
EUDRA - European office for drug regulatory affairs (not official)
EUDRACT - European clinical trials database
database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established
in accordance with Directive 2001/20/EC.
EUDRAVIGILANCE - pharmacovigilance in the European economic area
European data processing network and management system, for electronic data exchange of Individual Case
Safety Reports (ICSRs) of authorised medicinal products
FDA - Food and Drug Administration
US regulatory authority
GCP - good clinical practice
ethical basis/standard for the conduct of clinical trials
IB - investigator's brochure
document with a current compilation of the clinical and nonclinical data (i.e., scientific information) on
the investigational product(s) that is relevant to the study of the investigational product(s) in human
subjects
ICD - international classification of diseases
coding thesaurus for diseases, injuries, conditions, drugs and procedures (a WHO publication)
ICH - International Conference on Harmonization (of technical
requirements for registration of pharmaceuticals for human use)
joint initiative involving regulatory authorities and industry from Japan, European Union and the United
States to harmonise the scientific and technical discussions of the testing procedures, which are required
to ensure and assess the safety, quality and efficacy of medicines
IEC - independent ethics committee
independent group of experts who ensure the protection of the rights and well-being of subjects involved
in a trial
IFPMA - International Federation of Pharmaceutical Manufacturers
Associations
IIT/IST - investigator initiated/sponsored trial
IMPD - investigational medicinal product dossier
document to give information on quality of any IMP including reference products and placebos to be used in
the clinical trial and on data from non-clinical or clinical studies and from the clinical use of the
medicines
INN - international non-proprietary name
name for the identification of pharmaceutical substances or active pharmaceutical ingredients
(generic name)
IRB - institutional review board
independent group of experts who ensure the protection of the rights and well-being of subjects involved in
a trial
ISS/ISE - integrated summary of safety/efficacy
relevant document concerning data and statistics in drug applications
MCA - Medicines Control Agency
UK regulatory agency
MedDRA - medical dictionary for drug regulatory activities
coding thesaurus for AE (and concomitant diseases)
NCE - new chemical entity
chemical compound not previously described in the literature
NDA - new drug application
application to the FDA for a license to market a new drug in the United States
NICE - National Institute for Clinical Excellence (UK)
organisation that makes recommendations on treatments, clinical guidelines, interventional procedures and
technology appraisals
NIS - non-interventional study
design for investigations with an approved drug without any regulations on the treatment
("observation only")
OCR - optical character recognition
process of converting an image of text, such as a scanned paper document or electronic fax file, into
computer-editable text
PMS - post-marketing (authorisation) surveillance
expending information on an approved drug (mostly under safety aspects)
PSUR - periodic safety update report (ICH)
periodic report submitted by the sponsor to establish a risk-benefit analyses
QA - quality assurance
methodology (or department) that is intended to ensure a defined level of quality
QC - quality control
operational techniques and activities undertaken within the quality assurance system to verify that the
requirements for quality have been fulfilled
QOL - quality of life
subjective measure of a person's health and level of physical and social functioning
RDC/RDE - remote data capture/entry
data capture/entry into a remote database (sponsor) from the location at which data are generated
(investigator)
SAE - serious adverse event
any untoward medical occurrence that at any dose
- results in death
- is life-threatening
- requires or prolongs hospitalisation
- results in persistent disability
- is a congenital anomaly
SAP - statistical analysis plan
document developed in advance to define methods for the analysis of data (without knowledge of data or
treatments)
SDV - source data verification
check of CRF documentation versus original documentation at the trial site
S(m)PC - summary of product characteristics
basic information for health professionals on how to use the medical product safely and effectively
SOP - standard operating procedure
detailed, written instructions to archive uniformity of the performance of a specific function
SUSAR - suspected unexpected serious adverse reaction
all suspected adverse reactions related to an IMP (the tested IMP and comparators) which occur in the
concerned trial and that are unexpected and serious and are subject to expedited reporting
TEAE - treatment emergent adverse event
AE that occurred for the first time or worsened while receiving therapy since the start of that therapy
TESS - treatment emergent signs and symptoms
synonym to TEAE
TMF - trial master file (ICH)
ICH required documentation on a clinical trial
UADR - unexpected adverse drug reaction
ADR with nature or severity not consistent with the applicable product information (e.g. Investigator's Brochure
for an unapproved investigational product or package insert/summary of product characteristics for an approved
product)
WHO - World Health Organization
body of the United Nations
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