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Psi Phi: Bradley s Science Fiction Club Web site. 1996. Available at:
http://www.bradley.edu/campusorg/psiphi/DS9/ep/503r.htm.
Accessed October 8, 1997. (Journal Article on the Internet) McCoy
LH. Respiratory changes in Vulcans during pon farr. J Extr Med [se-
rial online]. 1999;47:237 247. Available at: http://infotrac.galegroup.
com/itweb/nysl_li_liu. Accessed April 7,1999; there are other com-
mon styles such as of the International Committee of Medical
Journal Editors, Uniform Requirements for Manuscripts Submitted
to Biomedical Journals
, example: Halpern SD, Ubel PA, Caplan AL.
Solid-organ transplantation in HIV-infected patients. N Engl J Med.
2002 Jul 25;347(4):284 7.; ! see Havard style, Vancouver style.
clastogen Substance causing toxic effects upon genetic material
(chromosomes) of cells, inducing permanent and transmissible
damages with microscopically detectable structural alterations
of chromosomes; ! see also aneugen, genotoxicity, toxicity
tests.
classification of recurrence Classification system used for describ-
ing recurrence of tumors after therapy: a = alive, without recur-
rence, B = alive with recurrence, C = alive, recurrence unknown,
D = dead without recurrence, E = dead with recurrence, F = dead,
recurrence unknown, G = lost, without recurrence; ! see also tu-
mor staging.
clean area EC (IV): an area with defined environmental control of
particulate and microbial contamination, constructed and used in
such a way as to reduce the introduction, generation and retention
of contaminants within the area ; ! see also cross contamina-
tion.
clearance (Cl) rate of drug elimination from the body (volume of
blood cleared of a drug per minute: Cl = 0.693 (Vd)/(t) = ml/min)
where the volume of distribution (Vd) is expressed in ml/kg and
the half-life (t) in minutes or hours; ! see also creatinine
clearance, elimination, pharmacokinetic.
28
clerical error syn. key-punch error; c.e. are mainly those of trans-
ferring information, e.g. person or instrument to document, docu-
ment to punch cards or computers, computer output to reports,
typing mistakes a.s.o.; ! see also bias.
cle clinical development plan Plan for clinical development of a new
drug, from first application in man to drug registration; such a plan
usually includes e.g.: overview of the therapeutic indication(s),
target product profile, profile of competitive drugs, properties of
the new substance, justification for development, overview of
principle clinical trials with design and size, drug supplies, staffing
requirements and financial resources; ! see study list.
clinical hold FDA: A c.h. is an order issued by FDA to the sponsor
to delay a proposed clinical investigation or to suspend an ongoing
investigation.
clinical investigation ! see clinical trial.
clinical program outline ! see study list.
clinical research assistant (CRA) ! see clinical research associ-
ate.
clinical research associate (CRA) syn. clinical research assistant;
person performing mainly the on-site monitoring activity of a
trial; also called home based CRA or local CRA if based outside
of the office of a company; some of these activities may be also del-
egated to a study nurse ; ! see also monitor.
clinical research coordinator (CRC) ! see clinical trial coordi-
nator, Study Coordinator.
clinical research executive (CRE) Member of the clinical research
staff, e.g. a monitor.
clinical research manager (CRM) syn. clinical trial manager; re-
sponsible person for a clinical project, including the supervision of
monitoring; nominated by the sponsor; ! see also clinical trial
coordinator.
clinical research organisation (CRO) ! see contract research
organisation.
clinical significance ! see delta value.
clinical study ! see clinical trial.
clinical trial (CT) syn. clinical investigation, clinical study; any sys-
tematic and carefully designed study on medicinal products in
human subjects whether in patients or non-patient volunteers ;
the aim of a CT is to discover or verify the effects of, and identify
any adverse reaction to (investigational) products and to study
their absorption, distribution, metabolism and excretion in order
to ascertain the efficacy and safety of the product; a CT can be
either prospective (nonrandomized observational cohort, ran-
domized controlled frequently double-blind , withdrawal,
29
rechallenge, etc.) or retrospective (historical control, case-
control study, cross-sectional study); activities concerning
CTs are usually divided into 4 stages: a planning or set-up phase,
requiring about a few weeks to several months for protocol and
case record form preparation, packaging, labelling and regula- cli
tory review incl. by an ethical committee, a patient treatment or
monitoring phase (including follow-up) and finally the analysis
as well as the reporting phase, requiring also a few weeks to several
months for data clean-up, quality assurance, statistical analy-
sis and report writing; ! see also design, medical office trial,
megatrial, multicentre trial, non-alpha site, postmarket-
ing surveillance, run-in phase.
clinical trial authorisation (CTA) Formal approval to do studies; in
some countries formal approval by health authorities to do studies
esp. with experimental drugs is requested (at least for genetically
modified organisms or the very first application of a new drug in
man), e.g. US, UK, France, most countries in Eastern Europe a.s.o.;
other countries have less strict regulations and only notification
to the health authority is necessary, e.g. Australia, Germany a.s.o.;
! see also clinical trial certificate, clinical trial exemption.
clinical trial certificate (CTC) Formal approval to do studies in the
UK; valid for 2 years, renewable; ! see also clinical trial autho-
risation, clinical trial exemption.
clinical trial compensation guidelines Guidelines produced by the
ABPI; according to which compensation should be paid when the
injury was attributable to the medicinal product or any procedure
provided for by the protocol, for the more serious injury of an en-
during and disabling character (not for temporary pain or discom-
fort), for injuries caused by procedures adopted to deal with ad-
verse reactions to a product under trial, regardless of whether the
reaction was foreseeable or predictable or whether the patient is
able to prove negligence of the company; ! see also insurance.
clinical trial coordinator (CTC) syn. clinical coordinator, trial c.,
study c., research c.; in large and complex trials it may be suitable
to nominate a person acting as liaison between sponsor and in-
vestigator and for administrative responsibilities, e.g. who coor-
dinates dates for visits, investigations a.s.o. but reviews also data
and records before monitor s visit; ! see also clinical research
manager, study coordinator, study nurse.
clinical trial data base (CTDB) Public data base that lists planned or
ongoing clinical trials; editors of biomedical journals request that a
clinical trial has been listed in a CTDB in order to be considered for
publication (International Committee of Medical Journal Editors:
Uniform requirements for manuscripts submitted to biomedical
30
journals: Writing and editing for biomedical publication; updated
October 2007); accepted databases are: www.actr.org.au, www.
clinicaltrials.gov, www.ISRCTN.org, www.umin.ac.jp/ctr/index/
htm, www.trialregister.nl; ! see also data base.
cli clinical trial exemption (CTX) Exemption from the need to gain
formal approval to perform clinical studies in the UK; ! see also
clinical trial authorisation, clinical trial certificate.
clinical trial manager ! see clinical research manager.
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