Sponsor Study guides, Class notes & Summaries

How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed ...

What is the minimal size of a prep room? correct answer: 12 x 14 What is the minimal size of a funeral home chapel? correct answer: 300 sq ft What type of flooring is required in a prep rm? correct answer: tile or cement What are the minimum requirements in a prep rm correct answer: Flush rim sink, floor drain, backflow preventer Besides a FD and embalmer, who are allowed in the prep room? correct answer: Mort student, immediate family, public official How long is the cooling...

Two correct answer in order to supervise a provisional licensee, the sponsor mush have been licensed for a minimum of ____ years Three correct answer Texas Law requires the funeral service establishment document the efforts to obtain permission to embalm for a minimum of ____ hours One must be a provisional licensee for a minimum of ___ months and a maximum of ___ months correct answer 12, 24 When does 'Funeral Directing' begin? correct answer First Call When does 'Funeral Directi...

APM PMQ EXAM QUESTIONS AND AN What should a business case include? - ANSWER-B - Background O - Options B- Benefits CA - Commercial Aspects R - Risks T - Timescales What are the 5 aspects of the PRAM? - ANSWER-Initiate Identify Assess Plan responses Implement responses What are the 5 phases in the extended project life cycle? - ANSWER-Concept Definition Development Handover and Closure Operations Who are potential stakeholders within a project? - ANSWER-Project Sponsor ...

CCRP SOCRA Exam - Practice Exam with 100% Correct Answers | Latest 2023/2024 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator ️ C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 ️ B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the heal...

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol - c. CTA and Ethics Committee Approval What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (legal and fina...

UHC Ethics and Compliance Certification 2023/2024 Exam| Questions and Verified Answers| Graded A Q: What does generic mean with marketing materials? Answer: materials that do not meet the marketing materials criteria and do not carry any plan sponsor information or logos Q: does generic materials require prior approval? Answer: no Q: What methods are considered marketing material? Answer: newspaper, tv, internet, radio advertisements, direct mail, postcards, fl...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... 00:27 01:29 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ... This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application In the top rig...

CEBS - GBA 1 - Practice Exam Questions with verified Answers Which of the following statements correctly describes minimum requirements that group benefit plans typically must meet in order to be prospectively rated on contract renewal? Which of the following statements correctly describes the term graduation as it applies to mortality tables? If the plan sponsor pays the premium, which of the following group insured benefits is taxable to the plan member? Which of the following statements ...