Please summarize each reading assignment in one sentence.
Note: You will need to register at http://www.medscape.com to get access to all the Medscape articles. Registration is free.
| Module | Reading Assignment | Summary Sentence |
| Module 1 | Lipsky, M. S., & Sharp, L. K. (2001). From idea to market: The drug approval process. Journal of the American Board of Family Medicine, 14(5), 362–367. | The article describes the drug process based on literature review and websites by addressing FDA policies and processes. |
| Module 2 | U.S. Food and Drug Administration. (2018, March 30). Benefit-risk assessment in drug regulatory decision-making. | The study integrates activities that relate to BRF under PDUFA VI and Cures Act. |
| Module 2 | Tokarski, C. (2005, February 15). HIPAA Privacy Rule thwarts clinical research recruitment. Medscape Medical News. | The article documents how the Health Insurance Portability and Accountability Act of 1996 affected clinical research. |
| Module 3 | U.S. Food and Drug Administration. (2020). Approved drug products with therapeutic equivalence evaluations (Orange Book).
Familiarize yourself with the Orange Book Website. |
The publication identifies approved drug products Food and Drug Administration (FDA) based on their effectiveness and safety |
| Module 3 | Review and familiarize yourself with FDA Form 1571–Investigational New Drug Application. | It is an FDA form 1571 used to investigate new drug application. |
| Module 3 | Review and familiarize yourself with FDA Form 356h–Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use. | It is an FDA form used for application to market a new or an abbreviated new drug for human use. |
| Module 3 | Motl, S., Miller, S. J., & Burns, P. (2003). Programs established by FDA to expedite patient access to medications. American Journal of Health-System Pharmacy, 60(4), 339–345. | The article reviews time of a new pharmaceutical, as well as accelerate patient access to medication for a serious or life threatening disease. |
| Module 4 | Emanuel, E. J., Crouch, R. A., Arras J. D., & Moreno, J. D. (2003). Ethical and regulatory aspects of clinical research: Readings and commentary. The Johns Hopkins University Press.
• Read Part I: Scandals and Tragedies of Research with Human Participants (pp. 1–20) |
It provides tragedies and scandals that are associated with human participants. |
| Module 5 | Koski, G., Aungst, J., Kupersmith, J., Getz, K., & Riomin, D. (2005). Cooperative research ethics review boards: A win-win solution? IRB: Ethics & Human Research, 27(3), 1–7. | The publication describes numerous models of cooperative review that include Multicenter Academic Clinical Research Organization, Regional Ethics Organizations, and the NCI’s Central IRB. |
| Module 6 | Morreim, E. H. (2004). By any other name: The many iterations of “patient advocate” in clinical research. IRB: Ethics & Human Research, 26(6), 1–8. | The publication offers the diverse meaning of patient advocate or research subject advocate. |
| Module 7 | Emanuel, E. J., Crouch, R. A., Arras J. D., & Moreno, J. D. (2003). Ethical and regulatory aspects of clinical research: Readings and commentary. The Johns Hopkins University Press.
• Read Part IX: Scientific Misconduct (pp. 385–395) |
It is a novel that offers guidelines to researchers to meet their goals in clinical research and scientific misconduct affects outcome of a study. |