SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)

SOCRA Practice Test Questions and Answers Already Passed Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest form? FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she...

CCRP SoCRA Exam Latest Update Rated A 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 C...

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, retrie...

SOCRA Questions and Answers Already Passed 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 -Inv...

SOCRA CCRP Exam Questions and Answers Rated A 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, cho...

CCRP SOCRA Exam - Practice Exam 1 Latest Update Already Passed 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...

SoCRA Study Guide Latest Update with Verified Solutions IRB approval the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research ...

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 Record...

SOCRA FDA Timelines Latest Update Graded A If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article 5 days If an article is used in an exempt way, this ...