SOCRA Certified Clinical Research Professional (CCRP) - CCRP Exam Practice Test

In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?

A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?

Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?

Which document was created as a response to unethical WWII human experiments?

In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?