SOCRA Guías de estudio, Notas de estudios & Resúmenes

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...

SOCRA Practice Test with 100% Correct Solutions Which of the following is a disclosure of financial interests form? -Answer-FDA Form 3455 Which of the following is a certification of financial interest form? -Answer-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: -Answer-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Answer-Investigational New Drug Application...

SOCRA CFR study sets, IND Set test 2024 with 100% Correct Answers 5-142 What records must be maintained by investigators for investigational drug supplies? 21 CFR 312.62 -Answer-Records of drug disposition including dates, quantities, and use by study subjects. 5-150 How must an investigator store investigational drugs which are also controlled substances? 21 CFR 312.69 -Answer-In a securely locked, substantially constructed cabinet or other enclosure with limited access to prevent thef...

SOCRA Cert Test-100% Solved Nuremberg Military Tribunals: The Doctor's Trial -Answer-War crimes and crimes against humanity: to perform medical experiments upon concentration camp prisoners and other living human subjects, without their consent, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts Nuremberg Military Tribunals: The Doctor's Trial -Answer-The American judges pronounced their verdict on Au...

SOCRA Test practice Questions and Answers 2024 The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects in research What is the minimum number of members required by an IRB -Answer-5 Which of the following are necessary to waive consent? A.Subject is unable to give consent B.No time or unable to contact next of kin C.Life-Threatening Condition D.No other treatment available E.All of the above -Answer-all of the above This form is used for the mandatory rep...

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 Actual Certification Exam 2024 questions and answers A-graded Electronic Records - CORRECT ANSWER-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 - CORRECT ANSWER-Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date...

SOCRA (CCRP) Exam Practice Questions and Answers 2024 The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - CORRECT AND ANSWER-Determining that the...

SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers Which of the following is a disclosure of financial interests form? - CORRECT ANSWER-FDA Form 3455 Which of the following is a certification of financial interest form? - CORRECT ANSWER-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - CORRECT ANSWER-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginnin...

SOCRA Certification Exam Guide 2024 with correct answer Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible...