CERTIFIED CLINICAL RESEARCH ASSOCIATE EXAM STUDY GUIDE ACTUAL 2025/2026 QUESTIONS AND 100% CORRECT ANSWERS

CERTIFIED CLINICAL RESEARCH ASSOCIATE EXAM STUDY GUIDE ACTUAL 2025/2026 QUESTIONS AND 100% CORRECT ANSWERS What resources do I need to develop a budget? - Answer -1. Schedule of Assessments 2. Institutional Fees 3. Evaluation and Procedure Charges 4. Staff Allocation with Hourly Rates Indirect Cost Rate (IDC) - Answer -All procedural and non-procedural line items. Exemptions: subject stipends /reimbursements. Non-refundable startup fees - Answer -1. Clinical Study Evaluation Committee (CSEC) IND Safety Reporting. 2. PI eCRF Training 3. Monitoring spaceNeed assistance in Online classes, Exams & Assignments? Reach out for Full Course Assistance, Plagiarism-free Essay Writing, Research Paper & Discussion Posts. Confidential & Secure! Email now at: 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) - 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 - 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): - Answer -If no subjects are enrolled the money will have to be refunded to the sponsor. Non-refundable start-up fees: - Answer -There are some sponsors that include stipulations such as receipt of all regulatory documents, IRB approval and/or site initiation visit. Price capping - Answer -Price capping is not desirable. Price caps on devices expose the institution to subst