Guías de estudio, Notas de estudios & Resúmenes

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...

Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application In the top right corner, form have OMB number. What does it stand for? - The form, which is submitted to the FD...

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...

Which of the following is a disclosure of financial interests form? - ANSWER-FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER-Investigational New Drug Application (1571) In the top right corner, form hav...

A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? a. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm b. This subject should undergo all study procedures as outlined in the protocol c. This subject only needs to undergo the st...

What is an orphan drug program? - ANSWER-FDA program that provides development of drugs for rare diseases Nuremburg Code - ANSWER-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - ANSWER-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - ANSWER-any unfavorable or unintended event associated with a research study Assent - ANSWER-a child's affirmative agreement to participate i...

ACT - ANSWER-Federal food drug and cosmetic acts agency - ANSWER-Food and Drug Administration Biometrics - ANSWER-Method of verifying ID based on measurement of physical features, repeatable features, where those features and/or actions are both unique to that individual and measurable closed system - ANSWER-Environment in which the system access is controlled by persons who are responsible for the content of electronic records that are on the system open system - ANSWER-Environment ...

Electronic Records - ANSWER-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

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...

When isn't an IND application needed? - ANSWER-IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - ANSWER--FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse...