Sponsor Study guides, Class notes & Summaries

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...

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...

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...

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...

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...

AHIP TRAINING Medicare Fraud, Waste, and Abuse Training EXAM 50+ QUESTIONS AND VERIFIED CORRECT ANSWERS 2023. AHIP TRAINING Medicare Fraud, Waste, and Abuse Training 1. Medicare plan means: A MA plan, MA-PD plan or PDP 2. Subcontractor means: **An individual or entity that provides services on behalf of a Medicare plan sponsor. This includes individuals and organizations with DIRECT relationship with the plan sponsor or individuals or organizations with INDIRECT relationship, such as ...

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 ...

Under the DOL regulation, many advisors to retirement plans and their participants will be - ANSWER-3(21) fiduciaries. They will act alongside other fiduciary service providers who are also not necessarily named in the plan document but who exercise discretionary control over plan provisions or plan investments. The advisor should educate the - ANSWER-plan sponsor about hiring fiduciary service providers, including the different roles service providers, including the different roles service p...

eSponsorship and Application Training (eSAT) Questions and Answers...

Events are categorized by which two things? Type of event (educational or marketing/sales) and sponsor Sponsor and whether it is formal or informal Venue and type of event (educational or marketing/sales) Type of event (educational or marketing/sales) and whether it is formal or informal - ANSWER- Type of event (educational or marketing/sales) and whether it is formal or informal