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SOCRA Exam Questions And Answers 2024

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...

SOCRA Exam Questions and answers | Latest 2024/25 RATED A+

SOCRA Exam Questions With 100% Correct Answers When isn't an IND application needed? - answerIND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - 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 research/literature information -Addi...

SOCRA Exam questions and answers already graded A+| Updated & Verified | 2024

SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024

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...

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...

SOCRA Exam Questions With 100% Correct Answers Respect for persons, justice, beneficence - answerList the three ethical principles of the Belmont report Experiment that involves a test article and one or more human subjects - does not include experiments which are nonclinical lab studies - answerDefine clinical investigation Someone who is or becomes A participate in research either as a recipient of the test article or as a control - answerHuman subject is: Life threatening circumstance...

Socra Exam Prep Exam Questions And Answers