SOCRA CCRP Study guides, Class notes & Summaries

SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADESOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE

SOCRA CCRP EXAM 2024 QUESTIONS WITH COMPLETE SOLUTIONS!!

SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE

SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

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...

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, safety, or welfare of a subject. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health...

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, duration, and procedu...

Nuremburg Code - Correct Answer-The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - Correct Answer-1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjec...

pril 30 1996 - Correct Answer-ICH GCP Development Date Quality - Correct Answer-ICH Q Efficacy - Correct Answer-ICH E Safety - Correct Answer-ICH S Multidisciplinary - Correct Answer-ICH M

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 analysi