clinical trial exemption

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clinical trial exemption2016-12-12T10:46:06+00:00

clinical trial exemption 

EVIDENCE-BASED MEDICINE, PHARMACOLOGY

A UK scheme which allows sponsors of drugs being evaluated for patient use to apply for approval for clinical studies by submitting supporting safety in humans data to the Medicines Control Agency–MCA.

The MCA approves or rejects the application (generally within 35 working days). Approval means that the company is exempt from the requirement to hold a clinical trial certificate–CTC

Reference www.cdisc.org/glossary/index.html 

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