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Ask The Experts Insights

Viewing all entries for: Ask the Experts

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HIPAA Regulations documents Ask the Experts

How should a site document a missing signature on a HIPAA authorization form?

Read More about How should a site document a missing signature on a HIPAA authorization form?
Doctor holding notebook Ask the Experts

Is IRB review required for publication of a case study?

Read More about Is IRB review required for publication of a case study?
business people talking at table Ask the Experts

Q&A on legalities of contracting a sub-investigator for a clinical trial

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man looking at laptop Ask the Experts

What are the IRB Reporting Requirements for Adverse Events?

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doctor holding tablet Ask the Experts

Do we need to submit safety events from another site to our IRB?

Read More about Do we need to submit safety events from another site to our IRB?
person thinking yes Ask the Experts

How should we handle financial conflicts of interest in FDA-regulated clinical trials?

Read More about How should we handle financial conflicts of interest in FDA-regulated clinical trials?
woman on couch with headset writing in notepad Ask the Experts

Is IRB review required for a research study conducted by a high school student?

Read More about Is IRB review required for a research study conducted by a high school student?
document translation Ask the Experts

What are the signature requirements for translated informed consent documents?

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Nurse holding medical equipment Ask the Experts

Does the Common Rule apply to Medicare-covered investigational device studies?

Read More about Does the Common Rule apply to Medicare-covered investigational device studies?
Nurse on phone while looking at paper Ask the Experts

Can participants be reconsented over the phone when an ICF is updated?

Read More about Can participants be reconsented over the phone when an ICF is updated?
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