Core Concepts and Principles Flashcards

An unexpected, serious, and related adverse event in an FDA-regulated drug study generally must be reported by the sponsor in an IND safety report. What does 'serious' include?

Answer: An event that results in death, hospitalization, or persistent disability

Serious adverse events include death, life-threatening events, hospitalization, persistent disability, or congenital anomaly.

What is the difference between anonymous and confidential data?

Answer: Anonymous data cannot be linked to the participant by anyone, while confidential data are identifiable but protected

Anonymous data have no link to identity, whereas confidential data can be linked but access is restricted.

Which IRB review category applies to research involving no more than minimal risk that fits specific federally listed categories?

Answer: Expedited review

Expedited review is used for minimal-risk research falling in categories listed by OHRP and can be done by one or more experienced reviewers.

The Nuremberg Code established which key principle for human research?

Answer: Voluntary consent of the human subject is absolutely essential

The first principle of the Nuremberg Code is that voluntary consent is absolutely essential.

Which type of bias occurs when participants change their behavior because they know they are being observed?

Answer: Hawthorne effect

The Hawthorne effect describes behavior change resulting from awareness of being studied.

Which document lists study staff and the specific study tasks the PI has assigned to each?

Answer: Delegation of authority log

The delegation log records which qualified staff members are authorized to perform specific trial duties.

Before changing study procedures in an approved protocol, what must normally happen?

Answer: The amendment is submitted to and approved by the IRB, unless needed to eliminate an immediate hazard

Protocol changes require prior IRB approval except when necessary to eliminate apparent immediate hazards to participants.