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National Health Act 61 of 2003

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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicinal Products in South Africa (MCC: 2.33, Sept 2016)

The document assist the reporting of adverse drug reactions (ADRs) and in the management of safety data during post-registration and post-marketing clinical trials. To confirm that you have the latest version of this document, please visit:

Related Tags (New Search): Safety,   Adverse Drug Reaction,   Clinical trials,   Medicines

Good Clinical Practices: Emergency Trolley (MCC: 9.60, Jun 2015)

Requirement for all site conducting clinical trials to have an emergency trolley. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party websites, and shall not be liable, in any manner…

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Reporting Adverse Drug Reactions in South Africa (MCC: 2.11, Dec 2012)

This guideline apply to the reporting of serious adverse event of medicine reported during clinical trial. It does not apply to the reporting of post-marketing adverse drug reaction. Refer to guideline 2.33 for the reporting of post-marketing adverse reactions to…

Related Tags (New Search): Clinical trials