Clinical Trial Sponsor Investigator
An individual who both initiates and conducts an investigation , and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.
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
