Property:RefPreview
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Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
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monitor
A person appointed by, and responsible to, the sponsor or Contract Research Organization (CRO) for the monitoring and reporting of progress of… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file +
patient/subject file
A collection of data consisting of all relevant information on the patient or subject (such as hospital file, consultation record… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product +
pharmaceutical product
Any substance or combination of substances which has a therapeutic, prophylactic or diagnostic use, or is intended to modify ph… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator +
principal investigator
The investigator serving as coordinator for certain kinds of clinical trials, e.g. multicentre trials.… +
protocol
A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, includ… +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization +
randomization
[…]… +
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raw data
All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconst… +
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ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment +
recruitment
[…]… +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event +
serious adverse event
An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disabi… +
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serious health threat
[…]… +
source data
[…]… +
source document
[…]… +
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sponsor
An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a cl… +
I
unanticipated serious adverse device effect
USADE
[…]… +
use error
[…]… +
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validation
Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the softw… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data +
verification (validation) of data
The procedures carried out to ensure that the data contained in the final report match original observations. These … +
N
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative.
The Strengthening the Reporting of Observational Studies i… +
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vulnerable subject
[..]… +
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witness
A person who will not be influenced in any way by those who are involved in the clinical trial, who is present and may provide assistance if r… +
