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How do I comply with Good Clinical Practices (GCP)?
How do I manage changes to my grant?
How do I report amendments, suspensions and terminations?
Must I obtain continuing review from the IRB?
Who should monitor subject 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 and when are reports expected?
What is HIPAA and how do I abide by the requirements?

Glossary Box

 

How do I manage changes to my grant?

You must comply with the terms and conditions of your award.  Always promptly inform your Program DirectorGlossary Term of any changes in your study such as:

  • Protocol amendments, suspensions or termination.
  • Change in informed consentGlossary Term or IRBGlossary Term approval status.
  • Annual IRB and IBCGlossary Term approvals.
  • Issues related to patient accrual or retention.
  • Serious adverse events.
  • FDAGlossary Term, DSMBGlossary Term or OSMBGlossary Term communications.
  • New staff human subjects training documentation. 

Some changes to your study may need prior approval by NHLBI such as:

  • Spending money more than 90 days before the start date of a new or recompeting award.
  • Changing key personnel.
  • Changing the grantee organization.
  • Changing the status of the grantee organization.
  • Adding a foreign component to a domestic organization, even if no money will go to the foreign site.
  • Taking a second extension of a final budget period.
  • Changing award terms and conditions, or undertaking any activities disapproved or restricted as a term of award.
  • Using salary funds in a career (e.g., K23) award for a new purpose.
  • Having alterations and renovations exceeding $300,000 in total costs.
  • Making any change in your project that constitutes a change in scope.

You must submit a Progress Report each year in order to continue to receive funding. For more details on these reports go to “How do I manage my budget?”

 

 

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