Good Documentation Practices is the systematic procedure for preparing, reviewing, approving, versioning, storing and archiving research documents. It is essential to protecting study participant’s safety, privacy and well-being, it is the foundation to quality data, and it is a regulatory requirement. This session covers the main components of good documentation, in accordance with current ICH GCP guidelines, including ALCOAC practices.
In this workshop you will learn to:
- Identify the general principles associated with GDP
- Name the criteria associated with ALCOAC
- Demonstrate the ability to record, make corrections, prepare explanatory notes and handle a late entry
Speaker: Sasha Pavlovich is the Clinical Research Quality Assurance Specialist at VCHRI. Her passion for quality and education was cultivated in her previous role as an experienced research coordinator with a background in neonatal, prenatal and maternal health. After completing her undergraduate and teaching degrees at UBC, Sasha worked in education, health promotion and international development at UNICEF and UNESCO. She completed her MA in Education and International Development in London, England, followed by graduate work in epidemiology at the London School of Hygiene and Tropical Medicine.
Go back to the event calendar.