Pearl's Certified Clinical Research
Associate Exam Study Guide
Frequently Tested Questions And
Answers|| Perfect ManualScript
\.Research - Answer- The systematic study of materials and sources in order to establish facts
and reach new conclusions.
\.Ethical - Answer- Conforming to an established set of principles or accepted professional
standards of conduct.
\.Budget development - Answer- The process of identifying all of the expenses associated
with participating in a clinical trial.
\.Budget negotiation - 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? - 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 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.
\.Payment frequency, payments may be based on: - Answer- 1. CRF completion /monitoring.
2. A milestone number of subjects enrolled; completed study visits. (A higher frequency of
payments is desirable).
,\.Per subject payments include what type of costs? - Answer- Per subject payments include
costs associated with each subject on each visit and they are often generated by the submission
of CRFs to the sponsor.
\.Standard of Care vs. research only - Answer- It must be determined which services are
standard of care (billable to the subject's insurance) and which services are billable to the study
so that they can be appropriately incorporated in the budget and billing compliance plan.
\.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.
\.Screen failures - Answer- Sponsors prefer to pay a flat fee for screen failures rather than
paying for actual costs incurred. Compensation for actual costs incurred is preferable.
\.IRB fees: - Answer- Pay attention to terms that limit the number of IRB amendments and
renewals that can be invoiced. These limits should be negotiated out of the budget.
\.IRB Fee Types - Answer- Initial Review, Annual Renewal, Amendment
\.Initial Investigational Pharmacy Fee - Answer- This is a one-time fee that includes study
initiation and closing costs. The fee reimburses the investigational pharmacy for the time that is
required of the pharmacist (PharmD) and/or pharmacy technician (PT) to perform non-
dispensing related tasks
\.What is the Investigational Maintenance Fee - Answer- This fee is assessed monthly starting
when inventory has been received until study close-out and study drug(s) are destroyed or
returned to sponsor. This fee may also be paid on an annual basis
, \.Drug Supplier/Manufacturer - Answer- means in addition to producing the drug, the
company also supplies the investigator with the drug for use in the study.
\.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.
\.Two categories of studies involving sponsor-investigators? - Answer- 1. STUDIES INVOLVING
INVESTIGATIONAL DRUGS DEVELOPED BY THE INVESTIGATOR
2. STUDIES INVOLVING A MANUFACTURER'S INVESTIGATIONAL OR APPROVED DRUG
\.EXEMPTIONS FROM THE REQUIREMENT FOR AN IND - Answer- According to 21 CFR
312.2(b) (Investigational New Drug Application 2014), investigations using a marketed drug or
biologic do not require submission of an IND if all six conditions below are met:
1. It is not intended to be reported to FDA in support of a new indication for use or to support
any other significant change in the labeling for the drug.
2. It is not intended to support a significant change in the advertising for the product.
3. It does not involve a route of administration or dosage level, use in a subject population, or
other factor that significantly increases the risk (or decreases the acceptability of the risk)
associated with the use of the drug.
4. It is conducted in compliance with the requirements for Institutional Review Board (IRB)
review and informed consent.
5. It is conducted in compliance with the requirements concerning the promotion and sale of
drugs.
6. It does not intend to invoke 21 CFR 50.24 (exception from informed consent for emergency
research).
Associate Exam Study Guide
Frequently Tested Questions And
Answers|| Perfect ManualScript
\.Research - Answer- The systematic study of materials and sources in order to establish facts
and reach new conclusions.
\.Ethical - Answer- Conforming to an established set of principles or accepted professional
standards of conduct.
\.Budget development - Answer- The process of identifying all of the expenses associated
with participating in a clinical trial.
\.Budget negotiation - 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? - 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 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.
\.Payment frequency, payments may be based on: - Answer- 1. CRF completion /monitoring.
2. A milestone number of subjects enrolled; completed study visits. (A higher frequency of
payments is desirable).
,\.Per subject payments include what type of costs? - Answer- Per subject payments include
costs associated with each subject on each visit and they are often generated by the submission
of CRFs to the sponsor.
\.Standard of Care vs. research only - Answer- It must be determined which services are
standard of care (billable to the subject's insurance) and which services are billable to the study
so that they can be appropriately incorporated in the budget and billing compliance plan.
\.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.
\.Screen failures - Answer- Sponsors prefer to pay a flat fee for screen failures rather than
paying for actual costs incurred. Compensation for actual costs incurred is preferable.
\.IRB fees: - Answer- Pay attention to terms that limit the number of IRB amendments and
renewals that can be invoiced. These limits should be negotiated out of the budget.
\.IRB Fee Types - Answer- Initial Review, Annual Renewal, Amendment
\.Initial Investigational Pharmacy Fee - Answer- This is a one-time fee that includes study
initiation and closing costs. The fee reimburses the investigational pharmacy for the time that is
required of the pharmacist (PharmD) and/or pharmacy technician (PT) to perform non-
dispensing related tasks
\.What is the Investigational Maintenance Fee - Answer- This fee is assessed monthly starting
when inventory has been received until study close-out and study drug(s) are destroyed or
returned to sponsor. This fee may also be paid on an annual basis
, \.Drug Supplier/Manufacturer - Answer- means in addition to producing the drug, the
company also supplies the investigator with the drug for use in the study.
\.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.
\.Two categories of studies involving sponsor-investigators? - Answer- 1. STUDIES INVOLVING
INVESTIGATIONAL DRUGS DEVELOPED BY THE INVESTIGATOR
2. STUDIES INVOLVING A MANUFACTURER'S INVESTIGATIONAL OR APPROVED DRUG
\.EXEMPTIONS FROM THE REQUIREMENT FOR AN IND - Answer- According to 21 CFR
312.2(b) (Investigational New Drug Application 2014), investigations using a marketed drug or
biologic do not require submission of an IND if all six conditions below are met:
1. It is not intended to be reported to FDA in support of a new indication for use or to support
any other significant change in the labeling for the drug.
2. It is not intended to support a significant change in the advertising for the product.
3. It does not involve a route of administration or dosage level, use in a subject population, or
other factor that significantly increases the risk (or decreases the acceptability of the risk)
associated with the use of the drug.
4. It is conducted in compliance with the requirements for Institutional Review Board (IRB)
review and informed consent.
5. It is conducted in compliance with the requirements concerning the promotion and sale of
drugs.
6. It does not intend to invoke 21 CFR 50.24 (exception from informed consent for emergency
research).
