Training

Module 1             Quality Standard & Ethical Principles in Human Research and Behavioral and Social Sciences Research

Module 2             Introduction to ICH GCP

Module 3             Institutional review board (IRB)/independent ethics committee (IEC)

Module 4             Informed consent

Module 5             Essential documents and document management

Module 6             Data collection and data management

Module 7             Subject recruitment, subject retention, and subject compliance

Module 8             Clinical Safety Data Management

Module 9             Investigational drug handling

Module 10          Quality control (QC) and quality assurance (QA) in clinical trial

Module 11          Ethical consideration in social and behavioral science research

Module 1             Introduction to the Training Program

Module 2             Introduction to development of medicinal product

Module 3             Quality Standard and Regulations in Clinical Trials

Module 4             Study Initiation, Start-up, and Ongoing Management Activities and Sponsor Expectations

Module 5             Clinical trial project management

Module 6             Essential documents and document control and filing

Module 7             Safety reporting and related regulations