Socra study guide 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...

5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects...

IRB approval - the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemptio...

SoCRA Study Guide Latest Update with Verified Solutions IRB approval the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) an investigational new drug application, ak...

IRB approval - the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemptio...

SoCRA Study Guide Questions and answers latest update 2024

IRB approval - the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemptio...

SoCRA Study Guide: Review Questions and answers. VERIFIED/ IRB approval - -the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - -a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - -an investigational new...

IRB approval - ANSWER-the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - ANSWER-a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - ANSWER-an investigational new drug application, aka a notice of claimed inv...