Socra exam prep questions Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2023 Update | 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 presen...

SOCRA Exam Prep Questions And Answers | 2023/2024 Tests SOCRA Exam Prep Questions And Answers | 2023/2024 Tests

Laws - passed by national legislative bodies; establish authority of national regulatory body Regulations - Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - "current thinking" of regulatory bodies; non-binding ICH - Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - developed by an organization (sp...

Laws - ANSWER-passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER-Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER-"current thinking" of regulatory bodies; non-binding ICH - ANSWER-Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - ANSW...

Laws - ANSWER-passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER-Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER-"current thinking" of regulatory bodies; non-binding ICH - ANSWER-Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - ANSW...

Laws - CORRECT ANS passed by national legislative bodies; establish authority of national regulatory body Regulations - CORRECT ANS Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - CORRECT ANS "current thinking" of regulatory bodies; non-binding ICH - CORRECT ANS Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for p...

Laws - CORRECT ANS passed by national legislative bodies; establish authority of national regulatory body Regulations - CORRECT ANS Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - CORRECT ANS "current thinking" of regulatory bodies; non-binding ICH - CORRECT ANS Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registratio...

SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine - ANSWER Electronic Records Electronic records must use secure, computer generated, time-stamped audit trail...

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 pr...

Socra Exam Prep questions and correct answers