Institutional Review Boards
Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at least five members that include scientists, doctors, and lay people. They review and approve clinical trials taking place within their jurisdiction before the trials can begin
The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IRB will not approve the research, or it will specify changes that must be made before the research can be done.
As part of their review, IRBs consider participant inclusion and exclusion requirements to be sure that appropriate people have been identified as eligible for the trial. They often look at how and where recruitment for clinical trials will occur.
IRBs review the adequacy of the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants.
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
