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or identifiable information. Note that according to FDA Health Canada. (2013). Drugs and Health Products.
regulations, when a subject withdraws from a study, the Glossary. Health Canada’s Clinical Trials Database.
data collected on the subject to the point of withdrawal
remain part of the study database and may not be removed. National Institutes of Health (NIH). (2016). NIH Clinical
Research Trials and You. Glossary of Common Terms.
Withdrawn: The clinical study stopped before enrolling its Bethesda, Maryland, USA.
first participant. A type of Recruitment status.
Clinical and Translational Research Institute. (2016).
Within-subject differences: In a crossover trial, variability Glossary of Clinical Research Terms. University of
in each subject is used to assess treatment differences. California, San Diego.

Women of child bearing potential: Women that have the Understanding Clinical Trials. (2013). F. Hoffmann-La
potential to become pregnant. Roche Ltd. GPS Public Affairs. Basel, Switzerland.

Women of childbearing potential not using
contraception: Clinical trial includes female subjects
who have the potential to give birth and are not using
contraception.

Women of child-bearing potential using contraception:
Clinical trial includes female subjects who have the
potential to give birth and are using contraception.

World Wide Web: All the resources and users on the
Internet that are using HTTP protocols. Also called the web
and www.

REFERENCES

Canadian Institutes of Health Research. (2016). Glossary of
Funding-Related Terms. Government of Canada.

Clinical Data Interchange Standards Consortium
(CDISC). Special Resource Issue (2011). CDISC
Clinical Research Glossary. Applied Clinical Trials.
appliedclinicaltrialsonline.com.

Clinical trials glossary & taxonomy. (2015). Cambridge
Healthtech Institute. Needham, Massachusetts, USA.

ClinicalTrial.gov. A service of the U.S. National Institutes
of Health.

EU Clinical Trials Register. Glossary of Terms used in EU
Clinical Trials Register. EMA/534108/2010.

Glossary of Clinical Trial and Statistical Terms. (2008).
Design, Execution, and Management of Medical Device
Clinical Trials. Wiley Online Library.

Guidance for Industry. E6 Good Clinical Practice:
Consolidated Guidance. U.S. Department of Health and
Human Services. Food and Drug Administration. Center
for Drug Evaluation and Research (CDER). Center for
Biologics Evaluation and Research (CBER). ICH April
1996.

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