What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - CORRECT ANSWER Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - CORRECT ANSWER Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - CORRECT ANSWER maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the: - CORRECT ANSWER ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - CORRECT ANSWER Investigators brochure During a multi site clinical study, whose responsibility is it to report subject recruitment rate? - CORRECT ANSWER The CRA An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol therapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The Investigator should inform the subject about the study and - CORRECT ANSWER Obtain consent from the subject for the study A site is in the start up phase of an industry sponsored phase 3 trial, and has received IRB approval. The site can begin enrolling subjects after... - CORRECT ANSWER A signed clinical trial agreement between the site and sponsor is in place 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? - CORRECT ANSWER 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. What benefit informatiom should be included in the ICF? - CORRECT ANSWER Wording indicating that there is no expected benefit should be included A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - CORRECT ANSWER Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. In a multi arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB? - CORRECT ANSWER PI Which of the following required elements should be included in a clinical trial protocol? - CORRECT ANSWER Subject inclusion and exclusion criteria Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - CORRECT ANSWER PI and Sponsor During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - CORRECT ANSWER Electronic medical record When considering participation in a study, the investigator should determine if he... - CORRECT ANSWER Sees enough patients who would qualify for the study