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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 my budget and when are reports expected?

Keep in mind that you are working with a limited amount of money, so your expenditure rate is important.  We expect you to have reasonable expenditures. When working with your grant funds, ask yourself:  Am I pacing myself? Am I spending all my money in the first month or two of the project?  Am I not spending the money fast enough?

As the PI, you are responsible for ensuring the prompt submission of two required annual reports to NHLBI: a progress report and fiscal spending report. In addition, if you have been awarded a Clinical Skills Development Core, an additional report is required. You may also wish to submit a carryover request. Below you will find details on each of these reports.

Progress reports
To continue NIHGlossary Term support of your research each year, you must submit a progress report using the PHS 2590 forms and instructions. A comprehensive annual progress report is to be prepared by the principal investigatorGlossary Term and should include:

  • A brief summary of major accomplishments that can be attributed to the project and a brief explanation of how they have contributed to furthering the stated goals of the program.
  • Previous and on-going barriers to patient recruitment and remediation plans. 
  • A completed inclusion enrollment report
  • A list of changes, if any, in the professional staffing since the last competitive review.
  • A list of all publications and completed (not "in preparation") manuscripts that have resulted from the project.

Your business office must submit your progress report and other required documents to NHLBI two months before the beginning of your next budget period.  NIH no longer reminds you of an imminent progress report by mailing you a pre-filled face page. Instead, it is notifying grantees by email, sending one message two months before the due date and another two weeks after the deadline, if the progress report is overdue. Remember to turn in progress reports on time!  Late or incomplete progress reports are major contributing factors to late awards.

Your Program DirectorGlossary Term reviews your progress report to determine whether NHLBI will continue funding your project. Grants management specialistsGlossary Term perform an administrative and sometimes a fiscal evaluation of your progress report.

To access a searchable list of due progress reports and pre-filled face pages, your business office must register with the NIH Commons. Then you can check out the Electronic Research Administration's Progress Report Search and use your institutional profile number to get this information for your grant. Contact your institutional business official, also known as an authorized organizational representative, to inquire about registration.

Clinical Skills Development Core Progress Reports

If you have been awarded a Clinical Skills Development Core grant along with your SCCOR or Cooperative Agreement grant, you will need to submit a progress report specific to the activities of your Skills Development Core Program. Reports are due at the end of the 3 rd and 5 th years of the grant. The following items need to be included in your progress report:

Skills Development Core Program Components

  1. A brief description of key components of your Skills Development Core Program, and how they have been implemented during the first two years of the program.
  2. The three most significant accomplishments that have resulted from your Skills Development Core Program during its first two years with an emphasis on accomplishments that could not have been achieved without specific Core Program support from the NHLBI.
  3. A description of opportunities included in your Skills Development Core Program that support new investigators in developing individual clinical research projects of their own.

  New Investigator Activities  

  1. Full name, degree(s), current level of training, and the anticipated training duration for each new investigator who participated in your Core Program during the current reporting period.
  2. A list of national and regional scientific meetings, seminars, workshops, and other clinical enrichment activities that Core Program new investigators attended as a result of your Skills Development Core Program.

New Investigator Career Development  

  1. The full citation for publication(s) and/or presentation(s) resulting from new investigators' participation in the Skills Development Core Program.
  2. New funding, if any, awarded to Skills Development Core Program new investigator(s) during the reporting period.

Financial Status Reports (FSRGlossary Term) are to be submitted annually, 90 days after the end of the budget period.  Grantees who are accountable for the use of program income should complete SF-269, FSR long form. All others should use SF-269A, FSR short form. 

Carryovers
Carryover is the way that an investigator may access unobligated balances from previous years to perform approved research that has been deferred from those years and is expected to be performed during the current budget year.  It may not be used for anticipated research aims that will be performed in a later budget year or to support new research aims. Unobligated funds may be used as an offset if they will not be needed within the lifetime of the grant to support research that falls within the scope of its approved research aims.

The carryover of unobligated dollars from one budget period to the next is automatic for most awards. However, NHLBI staff must approve requests for carryovers for those grants that are specifically excluded from automatic carryover, such as cooperative agreementsGlossary Term (U01). The GMSGlossary Term will determine if the grant qualifies for automatic carryover authority, based on NHLBI policy.  Contact your Program Director for information on the process for requesting carryovers.

 

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