Nsr studies - Study guides, Class notes & Summaries

Certified Clinical Research Professional (CCRP) Exam 100% Pass When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional informa...

Certified Clinical Research Professional (CCRP) Exam Already Passed When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional in...

GCP of Devices, Exam Questions and answers, rated A+ 510(k) Clearance - -A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately. Humanitarian Device Exemption (HDE) Holder - -The HDE Holder is the entity that obtains the approval of a HD...

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

Peds NBME Form 1 - Questions and Answers 14 yo girl w/ Down Hgb - 16.8 PE: mild-mod cyanosis; digital clubbing; S2 inc in intensity echo: large VSD, dilated main pulm artery cause of polycythemia? pulm artery HTN Down kids are at a higher risk of getting this - upper airway obstruction and congenital heart dz Down is associated w/ inc in anti-angiogenic factors > impairs fetal lung vessel growth > leading to pulm art HTN due to the L>R shunt and inc flow in the R.heart > pulmHTN oc...

SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSW...

CCRP SOCRA Preparedness baseline Exam knowledge Questions with Expertly written solution 2024/2025 What FDA regulations govern UADE reporting? - correct answer 21 CFR 812 (.15 and .3) What regulations govern research with pregnant women and fetuses? - correct answer 45 CFR 46 Subpart B What requirements must be met to conduct research with pregnant women/fetuses? - correct answer 1) With preclinical and clinical data on non-pregnant women assessing risk to pregnant women 2) Risk to fet...

Dysrhythmias Practice Questions with Correct Answers |100% Verified| A 26-year-old client with atrial fibrillation that has not responded to medication therapy has arrived at the hospital for an elective cardioversion. Which of the following patient statements most concerns the nurse? 1) "I can't wait to stop taking this Coumadin. I've been on this crap for weeks now." 2) "I'm starving. I haven't eaten anything in 3 hours." 3) "I feel really short of breath, can I lie down...

CITI GCP Training Questions and Answers Graded A+ ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate ...