Sponsor responsibilities - Study guides, Class notes & Summaries

ERISA - Answer- Employee Retirement Income Security Act 1974 SOC Reports - Answer- Service Organization Controls: for external vendors SOC 1 - Answer- Internal Controls & Financial reports; used by auditors SOC 2 - Answer- Security, availability, processing integrity, confidentiality and privacy controls;used by management, regulators, and others under an NDA SOC3 - Answer- Same as SOC2, but available for public use. Tribble V Edison - Answer- Landmark court case re fiduciary resp...

What AR governs the TAF sponsorship program - AR 600-8-8 Who is sponsorship mandatory for - First term soldiers What must the commander provide the sponsor - a) provide government transportation for military only, (if required and available) to pick up the soldier and family (b) provide adequate time away from assigned duties to preform sponsorship duties What are the qualifications must the sponsor have - (a) Grade equal to or higher than newcomer (b) Same gender, marital status, and mili...

WGU C426 Healthcare Values and Ethics Rated A+ Normative Ethics Attempt to determine what moral standards should be followed so that human behavior and conduct may be morally right. Consequential Ethics Theory of ethics emphasizes that the morally right action is whatever action leads to the maximum balance of good over evil. - What will be the effects of each course of action? - Will they be positive or negative? - Who will benefit? - What will do the least harm? Utilitarian Ethics The conce...

A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects - 1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subjects even if they are unable to identify subjects that meet entry criteria, which can help discriminate sites who are failing to make an effort to recruit from sites who have been unable to enroll subjec...

APM PMQ Question and answers 100% correct 2024/2025 APM PMQ 1.1 Explain three difference between functional and matrix organisation structures. - correct answer 1. Who to report to. 2. Individual skills/experience. 3. Progression for members. 1.1 Explain three difference between functional and project organisation structures. - correct answer 1. Who to report to. 2. Duration of team. 3. Individual skills/experience. 1.2 Explain two ways in which a organisational breakdown stru...

WGU C783 Exam (Latest 2024/ 2025 Update) Project Management| Questions and Verified Answers| 100% Correct| Grade A Q: Monitoring and Controlling Process group Answer: Monitoring and controlling consists of those processes that are performed to observe project execution, so that potential problems can be identified in a timely manner and corrective action can be taken, when necessary, to control the execution of the project Q: Project management process groups Answer: the pr...

What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Correct 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 -Correct Answer Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to -Correct Answer maintain an audit tra...

A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. - Independent Data Monitoring Committee A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of the investigational product in human subjects. - Investigator's Brochure A copy of the original re...

CA Life Insurance Practice Exam Questions and Answers 100% Pass A key person is typically all of the following, except: - Correct Answer ️️ --Not directly involved in sales, production, or service Key persons are employees whose contributions have a significant impact on the revenue and profitability of the company, especially in small businesses. They are typically: part of the management team, more highly paid, respected by customers, creditors, suppliers, and vendors, and have dire...

APM PFQ Exam Questions and answers 2024 verified to pass differentiate between types of permanent and temporary organization structures (including functional, matrix, and project) - correct answer explain the way in which an organizational breakdown structure is used to create a responsibility assignment matrix - correct answer Define each of the roles and from that you can assign responsibilities., example, the quality manager and marketing manager might come up with a scope expla...