LATEST ACRP-CP UPDATED WITH Q&A VERIFIED ANSWERS GRADED A+100% GUARANTEED

LATEST ACRP-CP UPDATED WITH Q&A VERIFIED ANSWERS GRADED A+100% GUARANTEED 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 information 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 New safety information has become available from the Sponsor about the IP being used in a clinical trial. The investigator must - CORRECT ANSWER-Submit a revised ICF to the IRB noting the new safety information Per ICH: an IRB must keep correspondence for at least how long after the completion of a clinical trial? - CORRECT ANSWER-3 Years When would an impartial witness be needed during the consent process for an illiterate subject? - CORRECT ANSWER-To observe the consent process A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be - CORRECT ANSWER-Phase II After completion of a study: the final trial close out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? - CORRECT ANSWER-The sponsors files A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - CORRECT ANSWER-ICF When should a research study involving human subjects be registered in a publicly accessible database? - CORRECT ANSWER-Before recruiting the first subject In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - CORRECT ANSWER-The subjects legally acceptable representative A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study? - CORRECT ANSWER-Consenting in the presence of figure of authority The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers - CORRECT ANSWER-Phase I Who is ultimately responsible for all aspects of the research conducted at a site? - CORRECT ANSWER-Principal investigator An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials and credibility of data - CORRECT ANSWER-GCP What event resulted in the Nuremburg Cod of 1949 - CORRECT ANSWER-Nazi Medical Experiments 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 In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - CORRECT ANSWER-The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - CORRECT ANSWER-The subject inclusion and exclusion criteria During a multi-site clinical study: whose responsibility is it to report subject recruitment rate? - CORRECT ANSWER-The CRA