Approval for the Implementation of Drug Clinical Trials.
UMKU Details
Parameter: All
Authority: Minister/Head of Agency
Requirements and Responsibilities:
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1. Conduct clinical trials in accordance with the approved protocol and Good Clinical Practice standards.
Duration: -
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2. Report serious drug adverse effects.
Duration: -
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3. Report progress of clinical trials.
Duration: -
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4. Report the completion of clinical trials.
Duration: -
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5. Report the termination of clinical trials.
Duration: -
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6. Report changes/amendments to clinical trial documents.
Duration: -
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7. Register clinical trials with the Ministry responsible for health-related government affairs.
Duration: -
Sector: Drugs and Food.
Status: Available
Belongs to:
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