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29 August 2008 /Side effects and trials
EU directive does not result in fewer clinical trials from independent researchers
In 2004, when the CT directive came into force, the GCP-rules became mandatory for the independent researchers and they were to meet the same requirements as their colleagues in the pharmaceutical industry - something which led many people to fear that it would result in less public research.
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11 January 2008 /Side effects and trials
Use of waivers in connection with the inclusion of trial subjects/patients in clinical trials
The EMEA GCP Inspectors Working Group has prepared a document with a common European position on the use of waivers in connection with the inclusion of trial subjects/patients in clinical trials.
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11 January 2008 /Side effects and trials
Reflection paper from EMEA's GCP Inspectors Working Group on expectations for electronic source documents used in clinical trials
The EMEA GCP Inspectors Working Group has prepared a reflection paper on the handling of electronic documents in connection with clinical trials.
