CCRP SOCRA FINAL EXAM 2026 ACTUAL QUESTIONS AND
ANSWERS RATED A+
✔✔Phase 4 studies - ✔✔post market studies that may reveal additional side effects,
adverse effects and drug interactions
✔✔Tor F: Countries are not to stockpile investigational drug as this prevents access of
the drug to other countries. - ✔✔False: IND may be stockpiled in anticipation of national
emergency with approval from FDA and HHS
✔✔2 specialized regulatory organizations - ✔✔1) Center for Drug Evaluation and
Research (CDER)
2) Center for Biologics Evaluation and Research (CBER)
✔✔If an IDE is approved, what is it exempt from? - ✔✔the requirements of the following
sections of Federal Food, Drug, and Cosmetic Act:
-Misbranding under section 514
-Premarket approval under section 515
-Banned device regulation under section 516
-Records and reports under section 519
-Restricted device and manufacturing practice requirements under section 520
✔✔IDE approval - ✔✔permits the use of a device that would otherwise be required to
comply with performance standards or have premarket approval to conduct
investigation, cannot be significant risk device
✔✔IDE cannot be ______________________ device - ✔✔significant risk device
✔✔implant - ✔✔a device that is placed into a surgically or naturally formed cavity in the
human body that is intended to stay there for 30+ days
✔✔noninvasive - ✔✔when applied to diagnostic device or procedure, device does not
penetrate or pierce the skin or mucous membranes of the body or enter in any other
location
✔✔True of False: if a device is IDE and IRB has been notified, it can be marketed -
✔✔false, and it must be labeled with "Caution"
✔✔How long should investigator or sponsor maintain records? - ✔✔2 years
✔✔FDA shall consider the use of investigation device under a treatment IDE if: - ✔✔1)
device is intended to treat or diagnose a serious/life-threatening disease or condition
2) no compatible or satisfactory alternative device or therapy is intended to treat or
diagnose the stage of the disease or condition
, 3) the device is under investigation in a controlled clinical trial for the same use under
an approved IDE or clinical trials have been completed
4) sponsor of investigation is actively pursuing marketing approval/clearance of
investigational device
✔✔_____________ of a treatment IDE shall submit progress reports on a
____________ basis to ____________ until filing marketing application - ✔✔sponsor
must submit on a semi-annual basis to reviewing IRBs and FDA
(after submitting marketing app reports become annual)
✔✔unanticipated AE must be reported by ___________to _______________in
________ business days - ✔✔investigator to sponsor in 10 days
and then sponsor to FDA within 10 working days
✔✔List 4 situations that must be reported by investigator to sponsor within 5 working
days. - ✔✔1) withdrawal of IRB approval
2) deviations
3) not obtaining ICF
4) significant risk device determinations
✔✔When obtaining informed consent, the PI should adhere to _____________ and the
ethical principles that have their origin in ________________. - ✔✔GCP and
Declaration of Helsinki
✔✔Sponsor responsibilities if IRB approval is withdrawn - ✔✔sponsor shall notify FDA,
IRBs, and investigator within 5 working days
✔✔The investigator should give the final report to ________________ within
______________________ following study completion. - ✔✔to sponsor within 3 months
✔✔Sponsor responsibilities if FDA approval is withdrawn - ✔✔sponsor shall notify IRBs
and investigator within 5 working days
✔✔If a device is recalled, ___________ should notify ____________ withing
_________ days - ✔✔sponsor should notify FDA within 30 days
✔✔If the sponsor determined that an unanticipated adverse device effect present
unreasonable risk to patients, what should occur? - ✔✔termination no later than 5
working days after sponsor's determination, and no later than 15 working days after
sponsor first received notice of effect
✔✔FDA 45 Code of Federal Regulations Part 46 - ✔✔public welfare/protection of
human subjects
(with general ICF requirements)
ANSWERS RATED A+
✔✔Phase 4 studies - ✔✔post market studies that may reveal additional side effects,
adverse effects and drug interactions
✔✔Tor F: Countries are not to stockpile investigational drug as this prevents access of
the drug to other countries. - ✔✔False: IND may be stockpiled in anticipation of national
emergency with approval from FDA and HHS
✔✔2 specialized regulatory organizations - ✔✔1) Center for Drug Evaluation and
Research (CDER)
2) Center for Biologics Evaluation and Research (CBER)
✔✔If an IDE is approved, what is it exempt from? - ✔✔the requirements of the following
sections of Federal Food, Drug, and Cosmetic Act:
-Misbranding under section 514
-Premarket approval under section 515
-Banned device regulation under section 516
-Records and reports under section 519
-Restricted device and manufacturing practice requirements under section 520
✔✔IDE approval - ✔✔permits the use of a device that would otherwise be required to
comply with performance standards or have premarket approval to conduct
investigation, cannot be significant risk device
✔✔IDE cannot be ______________________ device - ✔✔significant risk device
✔✔implant - ✔✔a device that is placed into a surgically or naturally formed cavity in the
human body that is intended to stay there for 30+ days
✔✔noninvasive - ✔✔when applied to diagnostic device or procedure, device does not
penetrate or pierce the skin or mucous membranes of the body or enter in any other
location
✔✔True of False: if a device is IDE and IRB has been notified, it can be marketed -
✔✔false, and it must be labeled with "Caution"
✔✔How long should investigator or sponsor maintain records? - ✔✔2 years
✔✔FDA shall consider the use of investigation device under a treatment IDE if: - ✔✔1)
device is intended to treat or diagnose a serious/life-threatening disease or condition
2) no compatible or satisfactory alternative device or therapy is intended to treat or
diagnose the stage of the disease or condition
, 3) the device is under investigation in a controlled clinical trial for the same use under
an approved IDE or clinical trials have been completed
4) sponsor of investigation is actively pursuing marketing approval/clearance of
investigational device
✔✔_____________ of a treatment IDE shall submit progress reports on a
____________ basis to ____________ until filing marketing application - ✔✔sponsor
must submit on a semi-annual basis to reviewing IRBs and FDA
(after submitting marketing app reports become annual)
✔✔unanticipated AE must be reported by ___________to _______________in
________ business days - ✔✔investigator to sponsor in 10 days
and then sponsor to FDA within 10 working days
✔✔List 4 situations that must be reported by investigator to sponsor within 5 working
days. - ✔✔1) withdrawal of IRB approval
2) deviations
3) not obtaining ICF
4) significant risk device determinations
✔✔When obtaining informed consent, the PI should adhere to _____________ and the
ethical principles that have their origin in ________________. - ✔✔GCP and
Declaration of Helsinki
✔✔Sponsor responsibilities if IRB approval is withdrawn - ✔✔sponsor shall notify FDA,
IRBs, and investigator within 5 working days
✔✔The investigator should give the final report to ________________ within
______________________ following study completion. - ✔✔to sponsor within 3 months
✔✔Sponsor responsibilities if FDA approval is withdrawn - ✔✔sponsor shall notify IRBs
and investigator within 5 working days
✔✔If a device is recalled, ___________ should notify ____________ withing
_________ days - ✔✔sponsor should notify FDA within 30 days
✔✔If the sponsor determined that an unanticipated adverse device effect present
unreasonable risk to patients, what should occur? - ✔✔termination no later than 5
working days after sponsor's determination, and no later than 15 working days after
sponsor first received notice of effect
✔✔FDA 45 Code of Federal Regulations Part 46 - ✔✔public welfare/protection of
human subjects
(with general ICF requirements)
