Upcoming Events

Past Events

Fundamentals of International Clinical Research Workshop
Rio de Janeiro, Brazil
March 30 – April 4, 2008

In March and April 2008, DMID and ICSSC hosted a five-day workshop on the fundamentals of international clinical research for investigators sponsored by the Division of Microbiology and Infectious Diseases. The workshop, attended by 33 researchers from seven countries, was held at the J.W. Marriott Hotel, near Rio de Janeiro's Copacabanna Beach, and included sessions on Good Clinical Practice, Study Design, Protocol Development, and Data Management and Analysis.

To view a specific presentation, click on its title. All presentations are in PDF format and require Adobe Reader to view. Presenters and authors retain copyright over these presentations and requests for use should be directed accordingly.

Day	Session	Presenter
Monday March 31	What is the ICSSC?	Michelle Immelman
	Beginning with the End in Mind	Kenneth Schulz
	The Role of Biostatistics	Mario Chen
	Introduction and Role of OCRA	Walt Jones
	Protecting Human Participants in Research: Historical and Ethical Perspectives	Jeremy Sugarman
	Primary Research Question: Definition of Endpoints	Mario Chen
	Ethics in the Design of Clinical Research	Jeremy Sugarman
	Sample Size Determination	Mario Chen
Tuesday April 1	Good Clinical Practice - ICH	Michelle Immelman
	Design of Observational and Experimental Clinical Studies:  Choosing Your Study Design	Kenneth Schulz
	Group Exercise:Design of Clinical Studies	Ken Schulz
	The Informed Consent Process	Jeremy Sugarman
	Role of Institutional Review Boards (IRBs)	Jeremy Sugarman
	Principles of Data Management	Erik Jolles
Wednesday April 2	Critical Elements of Randomized Controlled Trials	Kenneth Schulz
	SOPs, WIs, and Forms - Data Management	Erik Jolles
	GCP Requirements - Data Management	Michelle Immelman
	Retention in Randomized Controlled Trials	Ken Schulz
Thursday April 3	GCP Requirements - Protocols	Michelle Immelman
	Writing a Protocol	Deborah Hilgenberg
	Addressing Safety Issues in Protocol Development	Walt Jones
	Case Report Form (CRF) Design	Erik Jolles
	Safety Oversight Guidelines	Walt Jones
	Data and Safety Monitoring Boards	Mario Chen
	Source and Regulatory Documentation	Walt Jones
Friday April 4	GCP Requirements - Safety Reporting	Michelle Immelman
	Understanding Adverse Events	Deborah Hilgenberg
	GCP Requirements - Monitoring	Michelle Immelman
	Clinical Site Monitoring	Walt Jones
	GCP Requirements - QA/QC	Michelle Immelman
	Implementation of GCP Requirements - IRB GCP IC	Michelle Immelman
	Practical Considerations for Fielding a Research Study	Deborah Hilgenberg
	If Research is Not Published, It Did Not Happen	Kenneth Schulz