Nsr studies - Study guides, Class notes & Summaries

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...

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | 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 pr...

Air Methods Critical Care Exam(correct answers 2023) Before PFT's how long should a patient refrain from smoking? Using an inhaler? - CORRECT ANSWER-smoking: 6-8 h inhaler: 4-6 h What test must you do before performing an arterial puncture? - CORRECT ANSWERAllen's test; patency of the ulnar artery- if blood returns to hand in 15s, then the radial artery can be used for the puncture How long should one apply pressure after an arterial puncture? - CORRECT ANSWER5 minutes (20 min if the ...

52 yo man - 6 hrs after onset of severe, epigastric abd pain > began at cocktail party > was there for 4 hrs - 3 martinis, lot of food PMHx: HLD (statin) 100.4F 104/min 150/92 mmHg PE: diffuse tenderness over upper quadrants BL - esp epigastrium; no guarding/rebound labs: WBC WNL, BR 3 (direct 2.4), alk phos 210, AST 325, ALT 360, amylase 1200, lipase 600 most likely cause of symptoms? - ANSWER-common bile duct obstruction choledocholithiasis = stone in CBD lipase high so th...

SOCRA CCRP Exam Questions and Answers 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....

GCP Of Devices Questions And Answers 2024. 510(k) Clearance - CORRECT ANSWER 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 - CORRECT ANSWER The HDE Holder is the entity that obtains the ap...

510(k) Clearance - Answer- 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 - Answer- The HDE Holder is the entity that obtains the approval of a HDE from the FDA and may be a manufacturer, sponso...

GCP of Devices Questions and Answers 100% correct 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 HDE from the ...

GCP of Devices Exam Study Guide with Complete Solutions 510(k) Clearance - Correct Answer 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 - Correct Answer The HDE Holder is the entity that obtai...

CCRP SOCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025 In an SR study, who must approve the IDE application prior to the study start? - correct answer FDA In an NSR study, do sponsors and IRB's have to report to FDA prior to the study starting? - correct answer No SAE Reporting in Drug Trial (investigators and sponsor) - correct answer investigator - immediately reports to sponsor sponsor - 15 calendar days after learning of risk UADE in medi...