Clinical trial Study guides, Revision notes & Summaries

ACRP Boot camp Exam Questions and Answers Already Passed The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Post market device registries d. outcome and health services research d Who is ultimately responsible for all aspects of the research conducted at a site? ...

ACRP CCRA Exam Prep Questions and Answers 100% Pass Phase I Trial AKA Human Pharmacology Phase I Trial -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA Therapeutic Exploratory Phase II Trial -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therape...

Test Bank for Human Physiology an Integrated Approach 8th Edition (Silverthorn, 2019), All Chapters Covered, Complete Guide A+. Human Physiology: An Integrated Approach, 8e (Silverthorn) Chapter 1 Introduction to Physiology 1) Physiology is the study of A) the structure of the body. B) the tissues and organs of the body at the microscopic level. C) growth and reproduction. D) the normal functions of the organ systems. E) the facial features as an indication of personality. Answer: D Se...

ACRP CCRC Exam Prep Questions and answers 100% correctWhat are expected or possible consequences of over-estimation of recruitment potential? - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? Subject welfare When is the i...

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...

CITI Training - Good Clinical Practice Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices - correct answer Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - correct answer Determining that the study has maximized benefits and min...

The knowledge generated from explanatory research is most useful in A.clarifying relationships among nursing phenomenon. B. estimating the probability of specific outcome in a given situation. C. identify the nature and attributes of nursing phenomenon. D. manipulating the situation to produce the desired outcome. - Answer clarifying relationships among nursing phenomenon. Who is identified as the first nurse researcher? - Answer Florence Knightingale What was the first research ...

Key historical influences to pharmacology - -Civilizations: Greece, Egypt, China -Poison: Curare, Ergot -Religion Why was zinc oxide an important compound - currently found in topical creams (i.e. calamine) What did ancient greece, egypt, and china contribute - greece - opium - codeine + morphine egypt - senna, purgatives china - ephedrine (asthma) What is Curare's function as a poison + pharmaceutical - poison = paralysis/death, drug = anesthesia What is Ergot's function as a poison +...

Essentials of Nursing Research; Appraising Evidence for Nursing Practice 10th Edition Polit Test Bank. Research utilization is a process that begins with which of the following? A) A clinical problem that needs to be solved B) A problem-focused trigger C) A knowledge-focused trigger or research finding D) A well-worded clinical question 2. Which of the following is an example of a systematic review? A) An RCT study published in the journal Nursing Research B) A meta-analysis from the Coch...

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...