Knowledge Flashcards

Under 21 CFR 312.32, a sponsor must notify FDA of an unexpected fatal or life-threatening suspected adverse reaction no later than:

Answer: 7 calendar days after receipt

Unexpected fatal or life-threatening suspected adverse reactions require an IND safety report within 7 calendar days.

According to 21 CFR 56.107, what is the minimum number of members an IRB must have?

Answer: Five

FDA regulations require each IRB to have at least five members with varying backgrounds.

If a drug is approved for the studied indication, how long must an investigator retain study records under 21 CFR 312.62?

Answer: 2 years after the marketing application is approved

Records must be kept for 2 years after approval, or 2 years after the investigation is discontinued and FDA is notified if no application is approved.

Which form does a drug study investigator sign to commit to conducting the study per the protocol and FDA regulations?

Answer: Form FDA 1572

Form FDA 1572, the Statement of Investigator, lists the investigator's commitments under the IND.

Per ICH E6, how often should the Investigator's Brochure be reviewed and revised as necessary?

Answer: At least annually

ICH E6 states the IB should be reviewed at least annually and revised per the sponsor's written procedures.

Which type of submission may an IRB approve through expedited review?

Answer: Minor changes to previously approved research

Expedited review covers minimal-risk research in listed categories and minor changes to approved research.

Under 21 CFR Part 54, an investigator's equity interest in a publicly traded sponsor must be disclosed when it exceeds:

Answer: $50,000

A significant equity interest in a publicly held sponsor is one exceeding $50,000 during the study and for one year after.