CERTIFIED CLINICAL RESEARCH ASSOCIATE STUDY GUIDE EXAM | 219 QUESTIONS & 100% CORRECT ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ | ALREADY GRADED

CERTIFIED CLINICAL RESEARCH ASSOCIATE STUDY GUIDE EXAM | 219 QUESTIONS & 100% CORRECT ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ | ALREADY GRADED 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 Deeagles - Stuvia US 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) 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. Deeagles - Stuvia US Price capping ANSWER: Price capping is not desirable. Price caps on devices expose the institution to substantial financial risk and should be negotiated out of the budget. Sponsor ANSWER: The sponsor can be any legal entity, including a company, an academic organization, or an individual. Sponsor-Investigator ANSWER: An individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational drug is being administered, used, or dispensed. The following information is subbmitted to the FDA to obtain an IND. 1-10 ANSWER: 1. Cover letter 2. Form FDA 1571 [IND] 3. Form FDA 1572 (Statement of Investigator) 4. Introductory statement and general investigational plan 5. Investigator's Brochure 6. Protocol(s) 7. Chemistry, manufacturing, and controls information 8. Pharmacology and toxicology information 9. Previous human experience with dru