戻る Agenda
CRA’s Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Reg. Environment
Session Chair(s)
Maria del Pilar Torres
Clinical Operations Manager
PRAHS, Colombia
The evolving regulatory environment in clinical trials challenges clinical research associates (CRAs) to efficiently monitor the Informed Consent process. Today most countries have incorporated ICH guidelines into their regulations, GCP is the global standard for clinical research, and some countries are developing their own regulatory requirements (for example, Honduras) and others with regulations are drafting stricter regulations (for example, Guatemala andCosta Rica). CRAs must be aware of all the local regulations requirements when monitoring informed consents in different countries in Latin America. Due to the evolving regulations, the continuous review, training and search for any updates to the ICH Guidelines and local regulations are needed for the team.
Learning Objective : Discuss the importance of the global requirements needed in the Informed Consent Process (ICH-GCP); Identify the evolving regulatory requirements and updates; Describe how to conduct effective IC monitoring according to the different country-specific differences in today's environment.
Speaker(s)
Informed Consent: Promise, Pledge, Contract or Platitude?
Michael Swit, JD
Varian, United States
Senior Director, Legal, Regulatory Affairs
CRA's Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
Maria del Pilar Torres
PRAHS, Colombia
Clinical Operations Manager