Socra exam 2024 - Study guides, Class notes & Summaries

SOCRA EXAM 2024- with 100% Correct Answers ( A Graded) Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the c...

SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE|2024 ICFANSWERAn informed consent form (ICF) is used to ensure everyone involved in clinical research is a willing participant, with full knowledge of the potential risks and benefits to the extent that this is possible. ICHANSWERThis International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an ...

MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024 5 ️ The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained ️ 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 ️ The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a s...

CCRP SOCRA Exam 2024 With Correct Solutions April 30 1996 - Answer -ICH GCP Development Date Quality - Answer -ICH Q Efficacy - Answer -ICH E Safety - Answer -ICH S Multidisciplinary - Answer -ICH M guidance for industry, consolidated guideance - Answer -ICH E 6 Clinical Safety Data Management Definitions and Standards - Answer -ICH E2A Safety pharmacology studies for human pharmaceuticals - Answer -ICH S7A Electronic records, electronic signatures - Answer -21 CFR Part 11 Informed Con...

2023/2024 SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE Who was tried in the Nuremburg Military Tribunals and why? Correct Answer: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? Correct Answer: After 140 days of proceedings with testimony of 85 witnesses and submission of...

CCRP SoCRA Exam 2024

CCRP SOCRA EXAM 2024 PRACTICE EXAM QUESTIONS COMPREHENSIVE QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT) /ALREADY GRADED

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 Subpart C IRB Functions and Operati...

Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024 When isn't an IND application needed? - CORRECT ANSWER-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) - CORRECT ANSWER-FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human ...

SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 200 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) / ALREADY GRADED A+