training
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We periodically organize training courses for our Clinical Monitors on different themes:
• compliance to protocol in 100% of patients involved in the study • filling of informed consent form • CRF and Source Data Verification • conservation of documents and materials in the center • management of SAE (Serious Adverse Event) accordingly to regulations and SOPs • collection of complete and signed CRF • accounts of experimental Drug • writing of reports at any monitoring visit (during and at the end of the study) • withdrawing and returning to the Sponsor of drug and residual material • record-keeping requirements |
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