CCRP Practice Exam Questions and Answers

After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

Upon completion of a study, the investigator should do which of the following?

When can the IRB/IEC require that additional information be given to subjects as part of informed consent?

A sponsor received a report from an investigator regarding the investigator's use of an investigational device without having obtained informed consent. The sponsor must submit a copy of the report to the FDA within:

An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:

In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:

A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?

Protecting prisoners’ rights to voluntarily participate in research is an example of which Belmont principle?

In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?

A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?