DIA 2013 49th Annual Meeting
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CRA's Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
Track : Track 01: Clinical Operations
Program Code: 418
Date: Thursday, June 27, 2013
Time: 10:45 AM to 12:15 PM  EST
Location: 151B
CHAIR :
 Maria del Pilar Torres, (SCHNON), Clinical Research Manager, RPS Colombia LTDA, Colombia
SPEAKER (S):
 Michael A. Swit, Esq, JD (SCHNON), Special Counsel, Duane Morris, LLP, United States
Maria del Pilar Torres, (SCHNON), Clinical Research Manager, RPS Colombia LTDA, Colombia
Description
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.