SOCRA EXAM PREP | 2024 / 2025
Newly Updated | ALL EXAMS COMBINED | Questions and Verified Answers | Highly Rated Guide
Question:
What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56?
Answer:
1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug presents unreasonable and significant risk to subjects - assure disposition of out-standing drug and provide full report to FDA
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Question:
How long does a sponsor have to report study closure and full report to FDA if drug presented an unreasonable and significant risk to subjects?
Answer:
- working days
Question:
Who is responsible for generating a protocol per regulations, sponsor or investigator?
Answer:
21 CFR 312.53(c): investigator provides to sponsor (not usually case)
5.6.1-2 ICH GCP: sponsor utilizes qualified individuals as appropriate
throughout all stages of trial process from protocol design to analysis; sponsor should provide investigators with protocol, updated IB and time to review information before entering into agreement
Question:
In what 3 ways does a sponsor ensure investigators obtain informed consent before starting a subject in trial?
Answer:
1) Obtain signed FDA 1572 2) Provide sample ICF with all elements to investigator 3) Ensure appropriate monitoring
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Question:
What FDA regulations dictate AE/SAE reporting?
Answer:
1) 21 CFR 312.32
2) 21 CFR 812.46
Question:
What are IND safety reports?
Answer:
Reports from a sponsor to the FDA and all investigators about any potential serious risks associated with the IP - generated by sponsor and submitted within 15 calendar days of notification
Question:
What are the 4 types of incidences that require an IND safety report for drug studies?
Answer:
1) Serious and unexpected suspected adverse reactions 2) Findings from other studies that suggest significant risk in humans 3) Findings from animal/in-vitro testing that suggest significant risk in humans 4) Increased rate of occurrence of serious suspected adverse reaction from previous protocol/IB
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Question:
What are 3 examples of SUSARs for drug studies?
Answer:
1) Single occurrence of event that is known to be strongly associated with IP 2) 1+ occurrences of event not commonly associated with drug but otherwise uncommon in population 3) Aggregate analysis of events such as known consequences of disease that commonly occur in population but occur more frequently in IP treatment group
Question:
In what 4 ways can an IND safety report be submitted for drug studies?
Answer:
1) Narrative document 2) FDA Form 3500A 3) Electronic format that FDA can process, review, archive 4) Council for International Organziations of Medical Sciences Form (for foreign reactions)
Question:
What must a sponsor do if the FDA requests more information about an IND safety report for drug studies?
Answer:
Respond no more than 15 calendar days from receipt of request
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