Clinical trial - Samenvattingen, Notities en Examens

CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator ️ C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 ️ B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the heal...

Exam 1: NSG533 / NSG 533 (Latest 2024 / 2025 Update) Advanced Pharmacology Exam Review | Complete Guide with Questions and Verified Answers | 100% Correct - Wilkes Q: What are the goals set by ACE /ACCE and are they written in stone for all patients? Answer: Primary target for glycemic control is HbA1C Individualize HbA1C goal - based on...Duration of DM Age /life expectancy Comorbid conditions Known CVD or advanced comorbid conditionsHypoglycemic unawareness Individual patient considerations Q:...

N117 CLINICAL TRIALS EXAM LATEST UPDATE...

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...

Good Clinical Practice Quizzes- SET 1Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator - correct answer b. sub-investigator Any untoward medical occurrence that at any dose results in death, i...

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 ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

what is a clinical trial? : prospective experiment on humans; must have an intervention, should compare to a "control"; goal is usually to examine safety and/or efficacy of a therapeutic intervention Is it a drug? : drug is any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals." What is the purpose of a clinical tria...

Notes of all the lectures given for the course Clinical Development and Clinical Trials. This is also exam material.

CCRP SoCRA Exam Latest Update Rated A 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpa...

Clinical Trial - Answer- process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome - Answer- Clinical event, measurable indicator, subject reported response Feasibility of a Study - Answer- Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study Necessary controls in ...