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Insights Archive

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stethoscope on medical document and doctor studying data Ask the Experts

Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB

Read More about Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
Informed Consent on tablet Whitepapers

Informed Consent and COVID-19: An IRB Perspective on Navigating the New Normal

Read More about Informed Consent and COVID-19: An IRB Perspective on Navigating the New Normal
mother-daughter-consent Ask the Experts

What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?

Read More about What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
Nurse virtually speaking with elderly patient Ask the Experts

What are the regulations for training home health individuals who are working remotely to collect study data?

Read More about What are the regulations for training home health individuals who are working remotely to collect study data?
doctor with clipboard speaking to elderly patient Ask the Experts

Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?

Read More about Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?
COVID-19 patient looking out window Ask the Experts

How Should I Handle Changes to Research Made in Response to COVID-19?

Read More about How Should I Handle Changes to Research Made in Response to COVID-19?
Doctor with mom and child Ask the Experts

What are the requirements for parental permission (consent) in studies involving children?

Read More about What are the requirements for parental permission (consent) in studies involving children?
people sitting in waiting room Ask the Experts

Questions regarding the definition of “human subject”

Read More about Questions regarding the definition of “human subject”
people sitting in circle smiling Ask the Experts

What ethical safeguards are needed for research involving observation of group behavior?

Read More about What ethical safeguards are needed for research involving observation of group behavior?
doctor with gloves holding blood sample Ask the Experts

How do I handle a deviation in the use of blood specimens collected outside the timeframe?

Read More about How do I handle a deviation in the use of blood specimens collected outside the timeframe?
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