Contract Research Organization (CRO)
A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.
ComplianceOnline Training on Drugs Regulatory Requirements
Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
Critical Compliance and Major Changes for the EU Clinical Trials Directive
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
Making All Data Count: FDA Acceptance of non-US Clinical Trials
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
Budgeting for Clinical Trials: Understanding Costs of a Study and Which Costs Sponsors are Responsible to Cover
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
