| Question 1: What is the overarching difference between Phase I and Phase II trials? |
| Reference: | Lawrence M. Friedman · Curt D. Furberg David L. DeMets · David M. Reboussin Christopher B. Granger Fundamentals of Clinical Trials Fifth Edition, Springer, 2003 |
| Choice A: | Phase I trials focus on feasibility, while Phase II trials generate key, definitive evidence about efficacy |
| Choice B: | Phase I trials evaluate safety, while Phase II trials gather initial data about efficacy |
| Choice C: | Phase I trials gather initial data about efficacy, while Phase II trials demonstrate safety |
| Choice D: | Phase I trials generate randomized evidence, while Phase II trials are not ever randomized |
| Choice E: | Phase I trials are done after a new drug or device has been licensed to gather further safety data, while Phase II trials gather efficacy data |
| Question 2: The strategic partnership between academic institutions and industry partners on evaluating and implementing new technologies has the following characteristics EXCEPT |
| Reference: | Experience in commissioning the halcyon linac, Tucker et al, Volume 46, Issue10, October 2019, Pages 4304-4313 |
| Choice A: | Providing key clinical and real-world data for vendors to improve upon their prototype |
| Choice B: | Allowing academic institutions to have early access of new technologies, and publish based on their findings |
| Choice C: | Are often initiated by research investigators at major universities |
| Choice D: | With tight timelines and clearly deliverables specified in upfront scope of work |
| Question 3: Which of the following role assignments are not optimal in a RACI matrix for vendor-academic partnership on evaluating the feasibility of implementing a new type of linac? |
| Reference: | What is RACI chart? https://www.forbes.com/advisor/business/raci-chart/ |
| Choice A: | The lead photon physicist assigned to this project is responsible for the project |
| Choice B: | The physics resident is accountable for the project |
| Choice C: | The senior physicists overseeing QA is consulted on the project |
| Choice D: | The vendor representative is informed on the project |
| Question 4: Regarding general rules of interactions with vendors, which of the following is NOT appropriate for the physicists involved in the collaborations |
| Reference: | Code of ethics for the American Association of Physicists in Medicine (Revised): Report of Task Group 109. |
| Choice A: | Making purchase decision of a product or service based on its merits and not be influenced by personal inducements |
| Choice B: | Physicists involved in the collaboration should avoid disclosing identifiable patient information to vendors. Compliance with patient privacy laws must be ensured. |
| Choice C: | Any corporate proprietary information reveled during the collaboration must be respected and hold confidential. |
| Choice D: | Accepting gift or consultation arrangements in exchange for a sales transaction is a good move to build a successful relationship with vendors |
| Question 5: As a successful vendor-user collaboration example mentioned in the talk, for a quick evaluation of MLC motor RF shielding on MRgRT platform in a clinical setting, what tests were proposed and performed with vendor support? |
| Reference: | Cai et al. Med.Phys. 44(12) 2017. |
| Choice A: | Use magnetic field probe to measure field inhomogeneity while MLC is moving |
| Choice B: | Use magnetic field probe to measure field inhomogeneity while MLC is stationary |
| Choice C: | As an indirect approach, the SNR is measured during a real time MR imaging on an ACR phantom on three plans with moving or stationary MLC |
| Choice D: | Real time MR images were taken with or without RF shielding of MLC |
| Question 6: What do I need to do to ensure that my research is compliant with the regulations against corruption? |
| Reference: | AdvaMed Code of Ethics and the Anti-Kickback Statute |
| Choice A: | Do not link the research funding to a purchase |
| Choice B: | Document what I will deliver |
| Choice C: | Ensure that the funding is consistent with the deliverables |
| Choice D: | Regularly report on the work done |
| Choice E: | All of the above |
