Investigators brochure - Study guides, Class notes & Summaries

Certified Clinical Research Professional (CCRP) Exam 100% Pass 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 informa...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - maintain an audit trail, data trail, and edit trail. A research subje...

Certified Clinical Research Professional (CCRP) Exam 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 -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional in...

Certified Clinical Research Professional (CCRP) Exam Study Guide. 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 res...

Which of the following are the three principles included in the Belmont Report? Correct Answer Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Correct Answer Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of informed consent as described in the Belmont Report? Correct Answer Information, comprehen...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - Answer Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - Answer Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - Answer maintain an audit trail, data trail, and edit...

SoCRA Certification Exam 2023 with complete 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) Digi...

CCRC EXAM SOLVED 100% CORRECT!! Protocols 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 -intro of new drug/investigational product i...

RAC Exam Prep - EU MDD-AIMDD & MDR Similar but more detailed than the Essential Requirements - ANS-General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ANS-13485:2016 Which entity affixes it's identification number near the CE Mark? - ANS-Notified Body, if involved in the conformity assessment Un-classified devices not requiring CE mark - ANS-Custom-made, Investigational, Compa...

ACRP CP PRACTICE QUESTIONS And ANSWERS 2023/2024 100% CORRECT! What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER-Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER-Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data ha...