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...

1571 ` IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB Clinical and non-clinical data on the investigational product that is relevant to the study in human subjects; supplied prior to regulatory approval Study type - Open Label everyone knows the treatment St...

RIMS CRMP-Implementing the Risk Process questions and answers

RIMS - CRMP

RIMS-CRMP EXAM STUDY GUIDE QUESTIONS AND ANSWERS.

ACRP CCRC TEST WITH ALL ANSWERS CORRECT

ACRP CCRC Exam Prep Questions with solutions correct What are expected or possible consequences of over-estimation of recruitment potential? What should be the first consideration when conducting a clinical trial? When is the investigator allowed to deviate from the protocol? If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? Which c...

ACRP CCRC QUESTIONS AND ANSWERS 100% CORRECT. Legally acceptable representative Correct Answer: person whom is lawfully able to consent on behalf of another SAE Correct Answer: Serious Adverse Event - Results in death, is life-threatening, requires long-term hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect Source data Correct Answer: original clinical information from source documents (medical record information) Vulnerable su...

ACRP CCRC QUESTIONS AND ANSWERS 100% CORRECT. Source data Correct Answer: original clinical information from source documents (medical record information) Vulnerable subjects Correct Answer: *Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor *those in nursing home *minors *those unable to give consent ICH Correct Answer: International Conference on Harmonization Principles of ICH & GCP Correct Answer: *Protect research subjects *conduct...

ACRP Exam Practice QUESTIONS AND ANSWERS 100% CORRECT. ADR Correct Answer: Adverse Drug Reaction Audit Correct Answer: Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate Correct Answer: Confirmation audit took place Audit Report Correct Answer: Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail Correct Answer: Documentation o...