Costa Rica

*** Need an answer to your GCP query ? Post your query at HelpDesk ***

Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Costa Rica

Legislations

Law 5395, General Health Law, Articles 64-68 (1973) (Spanish)

Regulations

CONIS: Executive Decree No: 31078-S (2003) (Spanish)
CCSS: Regulation of Clinical Investigation in the Assistance Services of the Social Security Fund (2005)

Guidelines (CONIS):

Ethical and Legal Principles
Duties and Responsibilities of the National Council on Health Research, of Investigators, and of the Sponsor
Structure and Functioning of the Committee Network
Design of the Research Protocol
Requirements for the Submission of a Research Protocol
Informed Consent
Approval and Follow-up of a Research Project
Sanctions
Guidelines for Good Clinical Practice (1996)
Protocol for Clinical Trials

Opinion Poll

Which of the following general ethical issues to conduct clinical trials?

	Widespread agreement that sound ethical standards must be observed in clinical research
	To participants subject irrespective of the geographic
	Economic setting in which Clinical Trial is undertaken
	Obtaining consent from a participant under access to better healthcare and payment
	A lack of appropriately trained people and resources in ethics committees

This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

Biomarkers World Europe (22/05/12)

World Gene Therapy Congress 2012 (22/05/12)

Exploratory Clinical Development World Europe (22/05/12)

World Animal Health Congress Asia (11/06/12)

World Vaccine Congress Asia 2012 (11/06/12)

Opinion Poll

Links