Training Modules
- Introduction to Drug Lifecycle Safety Management
- Clinical Research Regulations, Legislations, Ethics and Good Clinical Practices (GCP)
- Hands-on virtual start-up activities, site qualification (PSSV), site initiation, interim monitoring, site management activities, close-out visits processes, investigational product (IP) inventory, reconciliation, reviews, storage and security. Knowledge of GCP/local regulations and organizational procedures in ensuring IP is appropriately (re)labelled, imported, and released/returned.
- Understanding an Informed consent form, virtual Inform consent process and assessments. Ensuring site staffs informed consent has been adequately performed and documented and ensure site staff demonstrates diligence in protecting the confidentiality of subject/patient.
- Clinical assessment of factors that might affect subject/patient’s safety, subject recruitment and clinical data integrity at an investigator/physician site.
- Introduction to Clinical Monitoring/Site Management Plan (CMP/SMP), Assessment of site processes, conducting a Source Document Review and Verification of appropriate site source documents, paper EDC and medical record against the EDC and in house CTMS system. Query resolution processes (remotely and on site).
- Review processes for on-site Investigator site files, subject safety (AE/SAE) and reconciling contents of the ISF with the Trial Master File (TMF) for accuracy, timeliness and completeness. Entering data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Broad understand of monitoring activities such as the issuance of confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per organizational SOPs and Clinical Monitoring Plan/Site Management Plan.
- High level understanding of an interim analysis and database locks.
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