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

Practice Questions for SOCRA exam VERIFIED 2022/2023

How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days How many members must sit on an IRB? 5 00:18 01:18 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB approval of research? (7) 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought fr...

CCRP SOCRA Exam Practice Exam #1 With Answers 2023.

SOCRA CCRP Practice Exam #1 2023 Edition Questions and Correct Answers,

SoCRA Certification Exam 2023 with complete answers 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) Digi...

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...

SOCRA CCRP 2023 EXAM WITH OVER 230 ACTUAL QUESTIONS AND VERIFIED ANSWERS GRADED A+ (2024 UPDATE)

SoCRA Exam 2023 What is an orphan drug program? Nuremburg Code Kefauver-Harris Amendment Adverse Event Assent Assurance Belmont Report what is beneficence according to the belmont report? What is respect for persons according to the belmont report? what is justice according to the belmont report? Clinical research common rule declaration of helsinki food drug and cosmetic act good clinical practice (GCP) human subject International Conference of Harmo...