Managing a clinical research grant involves much more than just enrolling patients into a study.  There are many activities that you, as the PI, are responsible to do.  You are expected to submit on-going reports (to your IRB and NHLBI), monitor subjects and study progress, budget and key personnel and communicate with many parties related to your project.  This section will help you to better understand which activities are involved in managing your clinical research grant and will answer the following questions:

• How do I comply with Good Clinical Practices (GCP)
  
  
• How do I manage my grant?
  
  
• How do I report amendments, suspensions and terminations?
  
  
• Must I obtain continuing review from the IRB?
  
  
• Who should monitor patient recruitment/retention?
  
  
• How do I report adverse events?
  
  
• How is data quality monitored?
  
  
• What if I wish to add extra sites or studies to my project?
  
  
• How do I manage my budget?
  
  
• What is HIPAA and how do I abide by the requirements?