Socra exam test 2023 - Study guides, Class notes & Summaries

SOCRA Final Exam Test 2023 (Questions and Answers) Latest Update Graded A+. How many days does Physician or Sponsor have to submit written summary of expanded access to the FDA after use? - correct answers15 days 21 CFR Part 312.34 - correct answersTreatment use of an Investigational new drug. During which phases is a treatment protocol usually made available? - correct answersDuring Phase 3 but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been...

SoCRA Certification Exam 4 Revised Questions and Answers 2023 Biometrics 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 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) ...

SoCRA Certification Exam Paper 1 Questions and Answers 2023. Biometrics 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 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) ...

SOCRAFinal EXAM TEST QUESTIONS WITH ANSWERS Latest Update 2023 (Already Graded A+) How long is the waiting period before a treatment IND study can be initiated? - correct answers30 days When will the FDA permit use of an investigational drug in widespread use? - correct answers-If the criteria for expanded access are met ( benefits outweigh risk, illness is life threatening, or if no alternative treatments are available) -If drug is being investigated in a controlled clinical trial under a...

2023 SoCRA Certification Exam (Answered) Randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH GCP E6 1.48) Regulatory Authorities Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data. Form 1572 Statement of investigator for IND Form 1571 Cover sheet for an ...

SOCRA Certification Exam 2023 with Complete Solution Biometrics - Correct 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 - Correct 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. (2...

Electronic Records - 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 Electronic Records - Audit Trail - Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete records. Electronic Records - Changes...

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