Pearl's Certified Clinical Research Associate Exam Study Guide questions with complete solutions

Research correct answer: The systematic study of materials and sources in order to establish facts and reach new conclusions. Ethical correct answer: Conforming to an established set of principles or accepted professional standards of conduct. Budget development correct answer: The process of identifying all of the expenses associated with participating in a clinical trial. Budget negotiation correct answer: The process of engaging the sponsor in a dialogue that results in a final budget that covers the costs of participating in a clinical trial. What resources do I need to develop a budget? correct answer: 1. Schedule of Assessments 2. Institutional Fees 3. Evaluation and Procedure Charges 4. Staff Allocation with Hourly Rates Indirect Cost Rate (IDC) correct answer: All procedural and non-procedural line items. Exemptions: subject stipends /reimbursements. Non-refundable startup fees correct answer: 1. Clinical Study Evaluation Committee (CSEC) IND Safety Reporting. 2. PI eCRF Training 3. Monitoring space 4. Recruitment 5. Record Retention 6. Radiology start-up 7. Pharmacy (start-up and close-out) Items requiring an invoice (not included in the per subject payment) correct answer: 1. Non-procedural fees (subject travel, dry ice) 2. Procedural assessments that do not pertain to every subject enrolled or may be considered optional per the study. Per subject payment withholding correct answer: Industry sponsors typically withhold a percentage of study payments until the study is completed. The percent withheld is usually 10% or greater. Advances against subject payment (enrollment-based): correct answer: If no subjects are enrolled the money will have to be refunded to the sponsor. Non-refundable start-up fees: correct answer: There are some sponsors that include stipulations such as receipt of all regulatory documents, IRB approval and/or site initiation visit.