Glossary entry (derived from question below)
Dutch term or phrase:
(here) loon (laboratory)
English translation:
contracting laboratory, contract laboratory
Dutch term
(Here) Loon (laboratory)
Is there an accepted phrase for these EMA appications ? Contracted?
TIA
3 +3 | contracting laboratory | Jack den Haan |
4 +1 | contract laboratory | Jack den Haan |
Jul 16, 2012 20:21: Maria Kopnitsky changed "Field" from "Medical" to "Law/Patents" , "Field (specific)" from "Medical: Pharmaceuticals" to "Law: Contract(s)"
Jul 31, 2012 19:24: Jack den Haan Created KOG entry
Jul 31, 2012 19:24: Jack den Haan changed "Edited KOG entry" from "<a href="/profile/2519">Jack den Haan's</a> old entry - "(Here) Loon (laboratory)"" to ""contracting laboratory, contract laboratory""
Proposed translations
contracting laboratory
http://www.ema.europa.eu/docs/en_GB/document_library/Regulat...
6.6. Sub-contracting laboratory analysis If analysis or evaluation of clinical trial samples is sub-contracted to another laboratory, the ability of the sub-contractor to perform the work must be assessed prior to its initiation. Particular attention should be paid to staff training.
Before placing work with a sub-contractor, the sponsor, or their representative, should be informed and, if necessary, the contract with the sponsor amended.
A contract or service level agreement should be implemented between the two laboratories prior to the initiation of any work. Any such contract or service level agreement should clearly state roles anddelegated tasks and the scope and nature of the work that will be undertaken by the sub-contractor.
Care should be taken to ensure that contracts do not conflict with the requirements of the clinical trial protocol, work instruction or the contract between the analytical laboratory and the sponsor.
contract laboratory
agree |
Josephine Isaacs (X)
2 hrs
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Thanks again, Josephine.
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