Clinical trial administration involves the management of all aspects of a clinical trial, from study planning and protocol development to data analysis and reporting. The administration of a clinical trial must follow strict guidelines and regulations to ensure the safety and well-being of study subjects and the validity of the data collected.
A source document is a record that contains original data and information collected during a clinical trial. Source documents can include medical records, laboratory results, participant diaries, and other documents that provide evidence of the trial’s conduct and results. Source documents are used to support the accuracy and reliability of the data entered into the case report form (CRF).
This course introduces the student to clinical trial implementation and management from the research site staff/team perspective. Topics include the identification and evaluation of sites and investigators and the coordination of subject participation.
Learning Points:
- Main Stakeholders of Clinical Trials
- Clinical Study Administration
- Informed Consent
- Subjects’ Recruitment, Enrollment, Follow-up, and Participation Completion
- Investigational Product Management
- Clinical Safety Management
- Detection and Recording of Adverse Events
- Clinical Study Documents
- Case Report Form (CRF)