Standard Operating Procedures

Multiple Choice

Which of the following is TRUE when obtaining informed consent from an illiterate participant?

• You cannot obtain consent from an illiterate participant because it violates Declaration of Helsinki and the Belmont Report.

• A trusted family member must serve as witness to the consenting process and will sign on behalf of the participant.

• The consent process will be videotaped or audiotaped. A study team member will read through each section of the ICF.

• A study team member may serve as a witness and advocate for the participant provided they sign documentation asserting they are impartial.

Multiple Choice

Which of the following authorities may audit a site?

• The sponsor

• The FDA and/or other regulatory authorities

• The IRB

• All of the above

Multiple Choice

TRUE or FALSE: Anticipated adverse events (listed in the investigational plan, protocol, informed consent documents and/or investigator’s brochure) do not need to be reported to the IRB.

• TRUE

• FALSE