SOCRA Guías de estudio, Notas de estudios & Resúmenes
¿Buscas las mejores guías de estudio, notas de estudio y resúmenes para SOCRA? En esta página encontrarás 443 documentos de estudio para SOCRA.
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SoCRA Certification Exam with complete solution
- Examen • 15 páginas • 2024
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SoCRA Certification Exam with complete solution 
Biometrics -Correct Answer-A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
Closed System -Correct Answer-An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, ...
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SOCRA exam| 168 questions and answers already graded A+| Updated & Verified | 2024
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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 information (drug dependence and abuse potential) 
How man...
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SOCRA Exam questions and answers already graded A+| Updated & Verified | 2024
- Examen • 76 páginas • 2024
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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, timestamped audit trails to independently record the date and time of entries and actions that create, 
modify or delete records. 
Electronic Records - Changes - Rec...
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SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024
- Examen • 58 páginas • 2024
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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 21 CFR 11, thr agency will consider the elect...
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SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide
- Examen • 675 páginas • 2024
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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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SoCRA Certification Exam Complete Questions with Graded A+ Answers
- Examen • 13 páginas • 2024
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SoCRA Certification Exam Complete Questions with Graded A+ Answers 
Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
Closed System 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3...
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SoCRA Certification Exam Complete Questions with Graded A+ Answers
- Examen • 13 páginas • 2024
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- 11,90 €
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SoCRA Certification Exam Complete Questions with Graded A+ Answers 
Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
Closed System 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3...
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Practice Questions for SOCRA exam questions and answers already graded A+| Updated & Verified | 2024
- Examen • 13 páginas • 2024
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Which of the following is a disclosure of financial interests form? - 
Which of the following is a certification of financial interest form? - 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following 
form: - 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational 
New Drug Application 
In the top right corner, form have OMB number. What does it stand for? - 
The form, which is submitted to the FD...
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SOCRA CCRP Exam Bundle Questions And Answers 100% Verified
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SOCRA CCRP Exam Bundle Questions And Answers 100% Verified
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Socra Exam Prep Questions With Solved Solutions
- Examen • 23 páginas • 2024
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Laws - ANSWER-passed by national legislative bodies; establish authority of national regulatory body 
 
Regulations - ANSWER-Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law 
 
guidance - ANSWER-"current thinking" of regulatory bodies; non-binding 
 
ICH - ANSWER-Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration 
 
SOPs - ANSW...
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