Socra exam Study guides, Class notes & Summaries
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SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide 
 
 
Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine - ANSWER Electronic Records 
 
 
 
Electronic records must use secure, computer generated, time-stamped audit trail...
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CCRP SOCRA Exams Questions and Answers 2023/2024
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CCRP SOCRA Exams Questions and Answers 2023/2024
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SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide
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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...
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CCRP SOCRA Exam - Practice Exam #1
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CCRP SOCRA Exam - Practice Exam #1
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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE|2024
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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 ...
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CCRP SOCRA Exam - Practice Exam 1
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CCRP SOCRA Exam - Practice Exam 1 
 
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, safety, or welfare of a subject 
 
B) P...
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CCRP SOCRA Exam | 100% Correct Answers | Verified | Latest 2024 Version
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CCRP SOCRA Exam | 100% Correct 
Answers | Verified | Latest 2024 Version
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SOCRA Exam Questions and Answers 100% Pass
- Exam (elaborations) • 103 pages • 2024
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SOCRA Exam Questions and Answers 100% Pass Electronic Records Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine 
Electronic Records - Audit Trail Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete records...
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SOCRA EXAM QUESTIONS AND ANSWERS
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SOCRA EXAM QUESTIONS AND ANSWERS
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SOCRA Exam Questions and Answers Already Passed
- Exam (elaborations) • 78 pages • 2024
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SOCRA Exam Questions and Answers Already Passed 
Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? 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 criteria specified in...
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