SOCRA EXAMINATION TEST SCRIPT 2026
COMPLETE QUESTIONS AND CORRECT
ANSWERS
◉ If an IND is on a clinical hold for more than one year,
______________________________
Answer: it is place on inactive status by FDA
◉ IND goes into effect _______ days after submission to FDA unless
notified prior
Answer: 30
◉ 2 reasons for inactive status
Answer: 1) IND is under clinical hold for 1+ year
2) no subjects enrolled for 2+ years
◉ IND that is inactive for ___________ can be terminated
Answer: 5 years
◉ True or False: Sponsor is not required to submit annual reports
for INDs of inactive status.
,Answer: True, and they must submit an amendment if they wish to
become active again
◉ purpose of phase 2 meetings
Answer: safety of proceeding to phase 3 and developing methods of
presentation and submission of data in the marketing application
◉ ________ can transfer responsibilities to CRO
Answer: sponsor
◉ Who selects monitors?
Answer: sponsor
◉ Primary purpose of trial monitoring
Answer: 1) rights and well-being of human subjects
2) accurate, complete, and verifiable data
3) compliance with protocol and GCP
◉ FDA form 1572
Answer: investigator statement
◉ sponsor should keep IP records for how long?
,Answer: 2 years
◉ FDA form 312.64
Answer: Investigator reports:
1) progress
2) safety
3) final
4) financial disclosure
◉ Who is responsible for making sure IRB complies with part 56?
Answer: investigator
◉ IRB 312 subpart E
Answer: Drugs Intended to Treat Life-threatening and Severely-
debilitating Illnesses
◉ requirements for drugs intended to treat life-threatening or
severely debilitating illnesses
Answer: -medical risk-benefit judgement by FDA and relative
experts to grant marketing approval
-no comparable or satisfactory alternative plan
, ◉ define immediately life-threatening/severely debilitating
Answer: major irreversible morbidity
(high likelihood of death)
◉ serious disease
Answer: A disease or condition associated with morbidity that has
substantial impact on day-to-day functioning
◉ Phase 4 studies
Answer: 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.
Answer: False: IND may be stockpiled in anticipation of national
emergency with approval from FDA and HHS
◉ 2 specialized regulatory organizations
Answer: 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?
COMPLETE QUESTIONS AND CORRECT
ANSWERS
◉ If an IND is on a clinical hold for more than one year,
______________________________
Answer: it is place on inactive status by FDA
◉ IND goes into effect _______ days after submission to FDA unless
notified prior
Answer: 30
◉ 2 reasons for inactive status
Answer: 1) IND is under clinical hold for 1+ year
2) no subjects enrolled for 2+ years
◉ IND that is inactive for ___________ can be terminated
Answer: 5 years
◉ True or False: Sponsor is not required to submit annual reports
for INDs of inactive status.
,Answer: True, and they must submit an amendment if they wish to
become active again
◉ purpose of phase 2 meetings
Answer: safety of proceeding to phase 3 and developing methods of
presentation and submission of data in the marketing application
◉ ________ can transfer responsibilities to CRO
Answer: sponsor
◉ Who selects monitors?
Answer: sponsor
◉ Primary purpose of trial monitoring
Answer: 1) rights and well-being of human subjects
2) accurate, complete, and verifiable data
3) compliance with protocol and GCP
◉ FDA form 1572
Answer: investigator statement
◉ sponsor should keep IP records for how long?
,Answer: 2 years
◉ FDA form 312.64
Answer: Investigator reports:
1) progress
2) safety
3) final
4) financial disclosure
◉ Who is responsible for making sure IRB complies with part 56?
Answer: investigator
◉ IRB 312 subpart E
Answer: Drugs Intended to Treat Life-threatening and Severely-
debilitating Illnesses
◉ requirements for drugs intended to treat life-threatening or
severely debilitating illnesses
Answer: -medical risk-benefit judgement by FDA and relative
experts to grant marketing approval
-no comparable or satisfactory alternative plan
, ◉ define immediately life-threatening/severely debilitating
Answer: major irreversible morbidity
(high likelihood of death)
◉ serious disease
Answer: A disease or condition associated with morbidity that has
substantial impact on day-to-day functioning
◉ Phase 4 studies
Answer: 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.
Answer: False: IND may be stockpiled in anticipation of national
emergency with approval from FDA and HHS
◉ 2 specialized regulatory organizations
Answer: 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?
