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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?
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