Certified Clinical Research Associate Exam Study Guide questions with correct answers

What resources do I need to develop a budget? CORRECT ANS 1. Schedule of Assessments 2. Institutional Fees 3. Evaluation and Procedure Charges 4. Staff Allocation with Hourly Rates Indirect Cost Rate (IDC) CORRECT ANS All procedural and non-procedural line items. Exemptions: subject stipends /reimbursements. Non-refundable startup fees CORRECT ANS 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 ANS 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 ANS 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