Investigator brochure - Study guides, Class notes & Summaries

ACRP-CP Certification Exam QUESTIONS AND CORRECT ANSWERS | ALREADY PASSED 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 el...

Investigator's Brochure - ANSWER Includes the rationale for investigating the IP, dose and regimen, risk/benefit ratio Investigator - ANSWER Responsible for IP at a site during a study

5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects...

CRA Exam Review Questions and answers, VERIFIED ALCOA - -Attributable Legible Contemporaneous Original Accurate Essential documents - -1572, Staff CV, Delegation Log, Medical Licenses, Lab Certificates, IRB approvals, Lab normal ranges, Lab director CV, Blank ICF, Blank SAE, Protocol Signature Page (PSP), Investigator Brochure (List sides effects of drug, Investigator Brochure Signature Page, past visit confirmation letters, and follow up letters. What is the role of a IRB? - -To Prot...

ACRP CCRC EXAM 2024 WITH COMPLETE SOLUTIONS ADR - Answer ️️ -Adverse Drug Reaction Audit - Answer ️️ -Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer ️️ -Confirmation audit took place Audit Report - Answer ️️ -Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer ️️ -Documentation of au...

SOCRA CCRP COMPLETELY VERIFIED EXAM DETAILED QUESTION & ANSWERS 100% GUARANTEED PASS EXAM.REVISED. An adverse reaction, the nature or severity of which is not consistent with the applicable product information (investigator's brochure) UADR Sponsor-Investigator An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. ...

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 ...

ACRP CCRC exam Questions and Answers 100% Correct The _________ has developed the Declaration of Helsinki (DoH): -Answer-World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. -Answer-the physician (DoH) In medical research, societal/scientific inter...

ACRP-CP Certification Exam 2024/25 EDITION GUARANTEED GRADE A+ 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 a...

When isn't an IND application needed? - 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) - 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 -Additional information (drug dependence and a...