SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: 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 Q: 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: 5 working days Q: 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 Q: 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 Q: What FDA regulations dictate AE/SAE reporting? Answer: 1) 21 CFR 312.32 2) 21 CFR 812.46 Q: 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 Q: 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 Q: 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 Q: 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) Q: 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 Q: What type of findings must be reported in narrative format in IND safety reports for drug studies? Answer: Overall findings or pooled analyses from published and unpublished, in-vitro, animal, epidemiological or clinical studies Q: Within what timeline must a sponsor notify the FDA of a fatal or life-threatening SUSAR for drug studies? Answer: Up to 7 calendar days Q: How soon must a sponsor conduct investigations of Unanticipated Adverse Device Effects? Answer: 21 CFR 812.46(b) - immediately Q: What 5 incidences must sponsors report to the FDA and/or investigators? Answer: 1) UADEs 2) Withdrawal of IRB approval 3) Withdrawal of FDA approval 4) Recall and device disposition 5) Significant risk device determination Q: How many days does a sponsor have to submit a report to the FDA/investigators/IRBs about withdrawal of IRB approval? Answer: 5 working days Q: How many days does a sponsor have to submit a report to investigators/IRB about withdrawal of FDA approval? Answer: 5 working days Q: How many days does a sponsor have to submit a report to FDA/investigators/IRB about returns, repairs or disposal of units of a device? Answer: Notice to be provided within 30 days after request was made - to include rationale Q: How many days does a sponsor have to submit a report to FDA about SR device if sponsor suggested NSR? Answer: 5 working days Q: What FDA regulations govern continuing review reports? Answer: 21 CFR 312.33 21 CFR 812.150(b)(5) Q: When must a sponsor submit a brief report of investigation progress to FDA for drug trials? Answer: Within 60 days of anniversary date that IND went into effect Q: What 3 main sections should be included in the FDA progress report for drug studies? Answer: 1) Individual study information 2) Summary information 3) General investigational plan Q: What are the three components of individual study information included in FDA progress report for drug studies? Answer: 1) Title, protocol #, purpose, pt population and status 2) # subject planned, enrolled, completed, withdrawn by gender, age, race, etc. 3) Available interim results Q: What are the 7 components of the summary information included in FDA progress report for drug studies? Answer: 1) Frequent and most serious adverse events 2) Summary of IND safety reports 3) List of subjects who died 4) List of subjects who dropped out due to AEs 5) New understandings of drug's actions 6) List of pre-clinical studies completed/in progress + findings 7) Significant manufacturing or microbiological changes Q: What are the 6 components of the general investigational plan included in FDA progress report for drug studies? Answer: 1) Rationale for study