Get Ready to Boost your Prepare for your ACRP-CP Exam with 127 Questions [Q27-Q45]

NO.27 Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

NO.28 All site financial matters pertaining to a trial are listed in what document?

NO.29 A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

NO.30 Who takes responsibility for initiating a clinical trial?

NO.31 In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

NO.32 A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

NO.33 A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

NO.34 A protocol amendment is needed to collect additional data from a participant’s medical record. When can the research team begin collecting the additional data?

NO.35 Which of the following should be considered when implementing a risk-based monitoring plan?

NO.36 Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator’s IMMEDIATE response?

NO.37 After the site qualification visit report has been finalized, it must be:

NO.38 A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

NO.39 The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

NO.40 Which one of the following is a primary objective of a Phase III study of a new IP?

NO.41 What would a sponsor use to implement and maintain quality in a study?

NO.42 The inclusion and exclusion criteria are in place so all subjects are:

NO.43 A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

NO.44 A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

NO.45 Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?