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How do I know if I am funded?
Who needs human subjects protection training?
Who approves my data monitoring plan?
What is a Certificate of Confidentiality and do I need one?
How do I develop consent forms and who reviews them?
Are there ethical concerns and conflicts of interest I must consider?
Do I need IRB, IEC or REB approval?
What other approvals are needed?
How do I track recruitment of research participants?
My study involves Medicare or third party support.
My study involves foreign grants and contracts.
How do I register my study?
When can I begin enrolling participants?

Glossary Box

 

My study involves Medicare or third party support.

Your research may incorporate financial support from third parties.  NHLBI has issued guidance on Third Party Involvement in NHLBI-Sponsored Clinical Trials and other Population-Based Studies. It is important to discuss your plans to partner with a third party with your Program Director before your study begins in order to obtain proper approval from NHLBI, if necessary.

Medicare Coverage of Clinical Trials will give you information about the CMSGlossary Term policy on what Medicare will pay for during a clinical trial and how this might be accomplished.

 

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