Irb practice test 2023 - Study guides, Class notes & Summaries

GLP Exam Definations 2023 Update Review FIFO - ANS-FIRST IN FIRST OUT - has to do with animals - feed, bedding, other lab supplies NIST - ANS-NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY QAI - ANS-QUALITY ASSURANCE INVESTIGATION QAU - ANS-QUALITY ASSURANCE UNIT - has to do with oversight - monitors each study - way for management to assure itself and other regulatory agencies that study was done according to GLPs - separate and independent from personnel engaged in conduct of study...

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...

CCRP Practice Questions and answers correctly 2023 Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - answerPI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - answerThe subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - answerThe subject inclusion and exclusion criteria During...

RAC Practice Exam 1 Questions and Answers New Version 2023 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic reco...

Genetic Counseling Boards Review Questions and Answers (summer 2023/24). - A young patient (5yrs) presents for the first time to a new dentist with crowded teeth, making them very hard to clean. In further exploration of the issue, she learns that the child had delayed eruption of his teeth. The patient's mother also relays that her pediatrician has several times noted how prominent the veins of his scalp are and his short stature. However, she thinks that this is just part of the spectrum ...

SOCRA- 2023 100% accurate answers Belmont Report was created as part of? The national Research Act of 1974. Who was the Belmont Report formulated by? The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? 1996 What is the National Research Act? A set of regulations for the...

What is the purpose of HIPAA? – • Protect PHI from unauthorized disclosure/use; • Prevent fraud, waste and abuse (via Administrative Simplification); • Make health insurance portable under ERISA; • Move health care onto a nationally standardized electronic billing platform HIPAA resides in which CFR section? - 45 CFR sections 164.102 through 164.534 What are the subparts of HIPAA part 164? - HIPAA - 45 CFR 164, subparts: Subpart A - General rules Subpart C - Security Subpart D -...

CCRP (Ethical Principles/Informed Consent) Questions and Answers 2023 21 CFR Part 50.23 Exception from general requirements 1) The human subject is confronted by a life-threatening situation necessitating the use of the test article. 2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject. 3) Time is not sufficient to obtain consent from the subject's legal representative. 4) There is avai...

ACRP Practice Exam 2023 Questions and Answers Latest Update A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ...

SOCRA CCRP Exam 2023 questions and answers April 30 1996 ICH GCP Development Date Quality ICH Q 00:55 01:41 Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent ...