CCRP Practice Questions and Answers
Prior to archiving a study, documentation of IP destruction at the site should be filed in
the study files of the: - ✔PI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and
dated ICF? - ✔The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? -
✔The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it to report subject recruitment
rate? - ✔The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be: - ✔Phase II
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? - ✔IB
When considering participation in a study, the investigator should determine if he/she: -
✔sees enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate
subject? - ✔To observe the consent process
During a monitoring visit, what records would a CRA reference to verify a subject's
compliance to the study visit schedule and assessments? - ✔Electronic medical record
A site is screening potential subjects for a study looking at mild cognitive impairment.
One of the inclusion criteria is a score of 25 or less on a psychometric test, a research-
specific tool which measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects? - ✔A research assistant who
is certified to administer the psychometric test
A research study, in which there is no intended clinical benefit to the subject, is being
submitted to the IRB/IEC. What benefit information should be included in the ICF? -
✔Wording indicating that there is no expected benefit should be included.
A research subject's responsibilities for study participation should be described in the: -
✔ICF
