SOCRA Study guides, Class notes & Summaries

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

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

SOCRA EXAM 2024- with 100% Correct Answers ( A Graded) Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the c...

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)

Contract Research Organization - ANSWER A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER False-they must sign both What is FDA form 3454 - ANSWER Certification Financial Interests and Arrangements of Clinical Investigators

Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - ANSWER An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - ANSWER An electronic signature...

A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER 444mg^3/m Which countries are included in the ICH GCP? - ANSWER European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANSWER

If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article - ANSWER 5 days If an article is used in an exempt way, this should be reported to the IRB in X after the use of the article - ANSWER 5 days Emergency use of a test article must be reported to the IRB in X time. Any subsequent use is subject to IRB review - ANSWER 5 days

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT AND ANSWER-Determining that the study has a maximization of benefits and a minimization ...

SOCRA TEST 1 QUESTIONS AND CORRECT ANSWERS