Ccrp Study guides, Class notes & Summaries

Adverse Event (AE)/Adverse Experience Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product i...

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...

ACRP CCRC Exam Prep Questions and Answers (All Correct) 299 Questions

CCRP AACVPR questions & answers 2023 What influences a persons metabolic rate? - ANSWER-Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - ANSWER-Fat Foods that raise insulin levels have... - ANSWER-added sugar When feeling stressed, you may feel relief after eating a piece of chocolate because... - ANSWER-it will raise dopamine levels What reduces the number of receptors for dopamine - ANSWER-insulin W...

CCRP AACVPR question and answers latest 2023How are lipids carried on lipoproteins in the blood because they are insoluble in water Proteins found on lipoproteins apolipoproteins Density of lipoprotein with less lipid and greater protein more dense Density of lipoprotein with more lipids and less protein less dense Major bloodstream lipoproteins chylomicrons, vLDL, LDL, HDL Chylomicrons least dense of the lipoproteins and are triglyceride-rich particles t...

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 How long must an IRB retain records per 21 CF R 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 from subjects or LARs 5. Informed consent w...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 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 health, s...