SOCRA CCRP Comprehensive Questions and
answers 100% Correct
_______ may request to review documentation and reports from ________ - CORRECT
ANSWER ✔✔ -FDA request from investigator (who should permit the request)
________ can transfer responsibilities to CRO - CORRECT ANSWER ✔✔ -sponsor
__________ must notify ________ and ________________ of safety risks regarding an IND
within _____ days - CORRECT ANSWER ✔✔ -sponsor must notify FDA and investigators
within 15 calendar days
___________ must report study endpoints to __________ - CORRECT ANSWER ✔✔ -sponsor
to FDA
___________ reports emergency use to __________ within ______ days - CORRECT
ANSWER ✔✔ -investigator to IRB in 5 working days
_____________ is responsible for providing Investigators brochure to ______________ and then
they provide it to __________________ - CORRECT ANSWER ✔✔ -sponsor to PI and then PI
to IRB
_____________ of a treatment IDE shall submit progress reports on a ____________ basis to
____________ until filing marketing application - CORRECT ANSWER ✔✔ -sponsor must
submit on a semi-annual basis to reviewing IRBs and FDA
(after submitting marketing app reports become annual)
,___________________ was created after the Tuskegee trial - CORRECT ANSWER ✔✔ -
Belmont Report
"active protocol" - CORRECT ANSWER ✔✔ -initial review and continuing review every 12
months
2 methods to reduce/avoid bias - CORRECT ANSWER ✔✔ -randomization and blinding
2 reasons for inactive status - CORRECT ANSWER ✔✔ -1) IND is under clinical hold for 1+
year
2) no subjects enrolled for 2+ years
2 specialized regulatory organizations - CORRECT ANSWER ✔✔ -1) Center for Drug
Evaluation and Research (CDER)
2) Center for Biologics Evaluation and Research (CBER)
21 CFR Part 314 - CORRECT ANSWER ✔✔ -Applications for FDA Approval to Market a New
Drug
21 CFR Part 814 - CORRECT ANSWER ✔✔ -Premarket Approval of Medical Devices
3 elements of ICF according to Belmont Report - CORRECT ANSWER ✔✔ -1) information
(benefits and risks)
2) comprehension (may include comprehension tests)
3) voluntariness
, 45 Code of Federal Regulations part 46 Subpart B - CORRECT ANSWER ✔✔ -additional
protections for pregnant woman, human fetuses, and neonates involved in research conducted or
supported by Department of Health and Human Services (DHHS)
45 Code of Federal Regulations part 46 Subpart C - CORRECT ANSWER ✔✔ -additional
protections pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving prisoners as subjects
45 Code of Federal Regulations part 46 Subpart D - CORRECT ANSWER ✔✔ -additional
protections pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving children as subjects
acceptable risk level for mother and fetus - CORRECT ANSWER ✔✔ -no greater than minimal
risk and consent of both parents required
According to _________ how long should IRB records be retained? - CORRECT ANSWER ✔✔
-45 Code of Federal Regulations Part 46: Public Welfare, 3 years
According to the Declaration of Helsinki, while the primary purpose of medical research is to
____________________, this goal can never take precedence over the ___________________ -
CORRECT ANSWER ✔✔ -generate new knowledge; rights and interests of individual research
subjects
adverse drug reaction (ADR) - CORRECT ANSWER ✔✔ -all noxious and unintended responses
to a medicinal product, causal relationship is at least a possibility
answers 100% Correct
_______ may request to review documentation and reports from ________ - CORRECT
ANSWER ✔✔ -FDA request from investigator (who should permit the request)
________ can transfer responsibilities to CRO - CORRECT ANSWER ✔✔ -sponsor
__________ must notify ________ and ________________ of safety risks regarding an IND
within _____ days - CORRECT ANSWER ✔✔ -sponsor must notify FDA and investigators
within 15 calendar days
___________ must report study endpoints to __________ - CORRECT ANSWER ✔✔ -sponsor
to FDA
___________ reports emergency use to __________ within ______ days - CORRECT
ANSWER ✔✔ -investigator to IRB in 5 working days
_____________ is responsible for providing Investigators brochure to ______________ and then
they provide it to __________________ - CORRECT ANSWER ✔✔ -sponsor to PI and then PI
to IRB
_____________ of a treatment IDE shall submit progress reports on a ____________ basis to
____________ until filing marketing application - CORRECT ANSWER ✔✔ -sponsor must
submit on a semi-annual basis to reviewing IRBs and FDA
(after submitting marketing app reports become annual)
,___________________ was created after the Tuskegee trial - CORRECT ANSWER ✔✔ -
Belmont Report
"active protocol" - CORRECT ANSWER ✔✔ -initial review and continuing review every 12
months
2 methods to reduce/avoid bias - CORRECT ANSWER ✔✔ -randomization and blinding
2 reasons for inactive status - CORRECT ANSWER ✔✔ -1) IND is under clinical hold for 1+
year
2) no subjects enrolled for 2+ years
2 specialized regulatory organizations - CORRECT ANSWER ✔✔ -1) Center for Drug
Evaluation and Research (CDER)
2) Center for Biologics Evaluation and Research (CBER)
21 CFR Part 314 - CORRECT ANSWER ✔✔ -Applications for FDA Approval to Market a New
Drug
21 CFR Part 814 - CORRECT ANSWER ✔✔ -Premarket Approval of Medical Devices
3 elements of ICF according to Belmont Report - CORRECT ANSWER ✔✔ -1) information
(benefits and risks)
2) comprehension (may include comprehension tests)
3) voluntariness
, 45 Code of Federal Regulations part 46 Subpart B - CORRECT ANSWER ✔✔ -additional
protections for pregnant woman, human fetuses, and neonates involved in research conducted or
supported by Department of Health and Human Services (DHHS)
45 Code of Federal Regulations part 46 Subpart C - CORRECT ANSWER ✔✔ -additional
protections pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving prisoners as subjects
45 Code of Federal Regulations part 46 Subpart D - CORRECT ANSWER ✔✔ -additional
protections pertaining to research conducted or supported by Department of Health and Human
Services (DHHS) involving children as subjects
acceptable risk level for mother and fetus - CORRECT ANSWER ✔✔ -no greater than minimal
risk and consent of both parents required
According to _________ how long should IRB records be retained? - CORRECT ANSWER ✔✔
-45 Code of Federal Regulations Part 46: Public Welfare, 3 years
According to the Declaration of Helsinki, while the primary purpose of medical research is to
____________________, this goal can never take precedence over the ___________________ -
CORRECT ANSWER ✔✔ -generate new knowledge; rights and interests of individual research
subjects
adverse drug reaction (ADR) - CORRECT ANSWER ✔✔ -all noxious and unintended responses
to a medicinal product, causal relationship is at least a possibility
