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EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) +
d) Remote source data verification
[…]
Remote SDV may be considered for trials:
- involving COVID-19 treatment or prevention;
- investigating serious … +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment +
escape treatment
Any supplementary treatment provided to relieve the trial subject of symptoms caused by the investigated disease in the clinical tria… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee +
ethics committee
An independent body (a review board or a committee, institutional, regional or national), constituted of medical professionals and no… +
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ethics committee
EC
[…]… +
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final report
A comprehensive description of the trial after its completion including a description of experimental methods (including statistical meth… +
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https://basg.gv.at/gesundheitsberufe/klinische-studien/gute-klinische-praxis-und-gcp-inspektion/faq-dokumentation-gcp
Ist es korrekt, dass die Verwe… +
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DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 - +
https://www.bundestag.de/resource/blob/858466/8c44dd9b4dfc7f144f94db82693c8dba/WD-9-015-21-pdf-data.pdf… +
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https://www.ct-toolkit.ac.uk/routemap/r-and-d-submission
Clinical trials conducted on the premises of an NHS organisation, with NHS patients or with … +
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USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - +
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html
Research Categories
Resea… +
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https://www.myresearchproject.org.uk/
IRAS: Integrated Research Application System ; provides a single gateway for researchers to apply to the new NI… +
https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx… +
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independent
not involved in the development of the investigational device or the conduct of a clinical investigation (3.8), except for their specifica… +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent +
informed consent
A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent s… +
inspection
An officially-conducted examination (i.e. review of the conduct of the trial, including quality assurance, personnel involved, any delegati… +
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investigational medical device
[…]… +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product) +
investigational product (synonym: study product)
Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clini… +
investigator
A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qual… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure +
investigator’s brochure
A collection of data for the investigator consisting of all the relevant information on the investigational product(s), includ… +
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