SOCRA ACTUAL 2026 STUDY GUIDE QUESTIONS AND
SOLUTIONS RATED A+
✔✔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
4) site personell contacted
5)summary of what information was reviewed
6)significant findings and corrective action - ✔✔Written monitoring reports should
include what elements?
✔✔Investigator Responsibilities - ✔✔21 CFR 312.60-70
✔✔Investigator Responsibilities - ✔✔ICH E6 Section 4
✔✔1572 - ✔✔What form documents investigator agreement to investigator
responsibilities in drug trials?
✔✔Maintain adequate and accurate records
Investigator responsibilitiy - ✔✔21 CFR Part 312.62
✔✔Make study records available for inspection - ✔✔21 CFR Part 312.68
✔✔1) Inventory of product received by site, and date
2) Dispensing and return information for each subject
3)Specific protocol information like batch numbers, expiration dates, serial numbers,
unique codes assigned to trial subjects - ✔✔Drug accountability records should contain:
✔✔Single line through the error
Enter correct information
Initial and date the change
Provide explanation if needed
Do not obliterate error
No erasures
SOLUTIONS RATED A+
✔✔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
4) site personell contacted
5)summary of what information was reviewed
6)significant findings and corrective action - ✔✔Written monitoring reports should
include what elements?
✔✔Investigator Responsibilities - ✔✔21 CFR 312.60-70
✔✔Investigator Responsibilities - ✔✔ICH E6 Section 4
✔✔1572 - ✔✔What form documents investigator agreement to investigator
responsibilities in drug trials?
✔✔Maintain adequate and accurate records
Investigator responsibilitiy - ✔✔21 CFR Part 312.62
✔✔Make study records available for inspection - ✔✔21 CFR Part 312.68
✔✔1) Inventory of product received by site, and date
2) Dispensing and return information for each subject
3)Specific protocol information like batch numbers, expiration dates, serial numbers,
unique codes assigned to trial subjects - ✔✔Drug accountability records should contain:
✔✔Single line through the error
Enter correct information
Initial and date the change
Provide explanation if needed
Do not obliterate error
No erasures
