CCRP ACTUAL 2026 EXAM QUESTIONS AND SOLUTIONS
RATED A+
✔✔Sponsor - ✔✔Who is responsible for selecting qualified monitors?
✔✔1) Medical Monitor
2) Data Safety Monitoring Boards
3) On-site monitoring - ✔✔What are three types of monitoring the sponsor is
responsible for?
✔✔Sponsor Medical Monitor - ✔✔Who is responsible for clinical oversight, evaluating
safety information-trial wide?
✔✔Data Safety Monitoring Board - ✔✔Who is responsible for periodic review of study
data while study is in progress?
✔✔On-Site Monitors - ✔✔Who is responsible for periodic site visits?
✔✔1) Manufacturing, packaging, labeling and coding of the investigational drug
2) Providing the investigational product only to investigators participating in an
investigation
3)Maintain drug and device accountability records from manufacturing through use,
return and destruction - ✔✔What are SPONSOR responsibilities with regard to IP?
✔✔1) Signed 1572 or investigational agreement
2)CV
3)Protocol
4) Financial disclosure - ✔✔What documents must be obtained from an investigator
prior to study start?
✔✔Sponsor - ✔✔Who is responsible for submitting safety reports to sites?
✔✔Sponsor - ✔✔Who is responsible with providing pre-clinical and clinical study reports
in the information amendments to the IND?
✔✔Sponsor - ✔✔Who has the responsibility in submitting an annual report to the
IND/IDE?
✔✔Sponsor - ✔✔Who has the responsibility in maintaining quality assurance and
quality control systems, with SOPs, for all activities?
✔✔Sponsor - ✔✔Who has the responsibility to ensure the study is designed by qualified
individuals?
, ✔✔Sponsor - ✔✔Who has the responsibility to obtain an agreement from the
investigator to adhere to the protocol, obtain IRB approval and GCP compliance?
✔✔Sponsor - ✔✔Who is required to notify all parties involved, if warranted, of new
safety information adversely affecting subject safety?
✔✔During Marketing Applications - ✔✔When do sponsors have to submit summary
forms of financial disclosures to the FDA?
✔✔1) Compensation affected by study outcome or in the form of equity interest in
sponsor or compensation tied to sales
2)Significant equity interest in sponsor
3) Proprietary interest in tested product
4) Significant payments of other sorts to investigator or institution supporting activities of
investigator - ✔✔What are 4 types of financial disclosures?
✔✔All amounts - ✔✔What is the $ reportable amount for a financial disclosure if the
amount is based on study outcome?
✔✔All amounts - ✔✔What is the $ reported amount for a financial disclosure for
proprietary interest in the test product?
✔✔All amounts - ✔✔What is the $ reported amount for a financial disclosure for equity
interest in the sponsor?
✔✔>$50,000 - ✔✔What is the $ reported amount for a financial disclosure for equity
interest in a publicly traded company?
✔✔>$25,000 - ✔✔What is the $ reported amount for a financial disclosure for significant
payments?
✔✔Contract Research Organization - ✔✔Who may the sponsor transfer responsibility of
duties or functions?
✔✔Monitor Responsibilties - ✔✔ICH E6, Section 5.18
✔✔1) Verify the rights and well-being of human subjects are protected
2)Reported trial data are accurate, complete, and verifiable from source documents
3)The study is conducted in compliance with the study protocol, the GCP guidelines and
applicable regulations - ✔✔What are the primary purposes for study monitoring?
✔✔1) The investigator's name and site location
2) date of the visit
3) monitor's name
RATED A+
✔✔Sponsor - ✔✔Who is responsible for selecting qualified monitors?
✔✔1) Medical Monitor
2) Data Safety Monitoring Boards
3) On-site monitoring - ✔✔What are three types of monitoring the sponsor is
responsible for?
✔✔Sponsor Medical Monitor - ✔✔Who is responsible for clinical oversight, evaluating
safety information-trial wide?
✔✔Data Safety Monitoring Board - ✔✔Who is responsible for periodic review of study
data while study is in progress?
✔✔On-Site Monitors - ✔✔Who is responsible for periodic site visits?
✔✔1) Manufacturing, packaging, labeling and coding of the investigational drug
2) Providing the investigational product only to investigators participating in an
investigation
3)Maintain drug and device accountability records from manufacturing through use,
return and destruction - ✔✔What are SPONSOR responsibilities with regard to IP?
✔✔1) Signed 1572 or investigational agreement
2)CV
3)Protocol
4) Financial disclosure - ✔✔What documents must be obtained from an investigator
prior to study start?
✔✔Sponsor - ✔✔Who is responsible for submitting safety reports to sites?
✔✔Sponsor - ✔✔Who is responsible with providing pre-clinical and clinical study reports
in the information amendments to the IND?
✔✔Sponsor - ✔✔Who has the responsibility in submitting an annual report to the
IND/IDE?
✔✔Sponsor - ✔✔Who has the responsibility in maintaining quality assurance and
quality control systems, with SOPs, for all activities?
✔✔Sponsor - ✔✔Who has the responsibility to ensure the study is designed by qualified
individuals?
, ✔✔Sponsor - ✔✔Who has the responsibility to obtain an agreement from the
investigator to adhere to the protocol, obtain IRB approval and GCP compliance?
✔✔Sponsor - ✔✔Who is required to notify all parties involved, if warranted, of new
safety information adversely affecting subject safety?
✔✔During Marketing Applications - ✔✔When do sponsors have to submit summary
forms of financial disclosures to the FDA?
✔✔1) Compensation affected by study outcome or in the form of equity interest in
sponsor or compensation tied to sales
2)Significant equity interest in sponsor
3) Proprietary interest in tested product
4) Significant payments of other sorts to investigator or institution supporting activities of
investigator - ✔✔What are 4 types of financial disclosures?
✔✔All amounts - ✔✔What is the $ reportable amount for a financial disclosure if the
amount is based on study outcome?
✔✔All amounts - ✔✔What is the $ reported amount for a financial disclosure for
proprietary interest in the test product?
✔✔All amounts - ✔✔What is the $ reported amount for a financial disclosure for equity
interest in the sponsor?
✔✔>$50,000 - ✔✔What is the $ reported amount for a financial disclosure for equity
interest in a publicly traded company?
✔✔>$25,000 - ✔✔What is the $ reported amount for a financial disclosure for significant
payments?
✔✔Contract Research Organization - ✔✔Who may the sponsor transfer responsibility of
duties or functions?
✔✔Monitor Responsibilties - ✔✔ICH E6, Section 5.18
✔✔1) Verify the rights and well-being of human subjects are protected
2)Reported trial data are accurate, complete, and verifiable from source documents
3)The study is conducted in compliance with the study protocol, the GCP guidelines and
applicable regulations - ✔✔What are the primary purposes for study monitoring?
✔✔1) The investigator's name and site location
2) date of the visit
3) monitor's name
