Chapter 1- Research Elements:Concepts & Design for Quantitative, Qualitative, & Mixed Methods Inv...
This chapter will provide the learner with a deeper understanding of the four main types of quantitative research, will discuss characteristics and strategies utilized in qualitative research, and will also discuss design and challenges of mixed methods investigations.
Discuss the design, strengths and challenges of mixed methods investigations (the integration of quantitative and qualitative data within one investigation or extended study).
Explain theory and design involved in the four main types of quantitative research: descriptive, correlational, quasi-experimental, and experimental.
Describe characteristics and strategies utilized in qualitative research including ethnographic, case study, and historical designs.
Crystal Dunleavy, EdD, RRT
Chapter 2- Participant Safety and Ethical Considerations
This chapter will provide the learner with a deeper understanding of the historical context for ethics in research, will describe the rationale for obtaining informed consent, and will provide the learner with an understanding of the role of the institutional review board.
Differentiate between the different types of institutional review board applications and permissions.
Discuss the historical context for ethical considerations in research planning.
Describe both the rationale and context for informed consent.
Describe the process for identifying and reporting unanticipated and adverse events.
Megan Koster, Ed.D, RRT, RRT-NPS
Chapter 3- Investigational Product Development and Regulation
This chapter will provide the learner with an understanding of the three preclinical translational research parts to MedTech product development and discuss each phase of MedTech development, will provide an overview of FDA medical device classification categories and also provide the learner with definitions for common terms used in medical device development.
Define terms common to medical device development.
Recognize the focus of the product team during each phase of MedTech development.
Review the FDA medical device classification categories.
Describe the three preclinical translational research parts to MedTech product development.
Rob DiBlasi, BSRT, RRT, RRT-NPS, FAARC
Chapter 4- Clinical Research Study Operations & Regulatory Affairs:Lessons from the Commercial Se...
This chapter will provide the learner with an understanding of the purpose and conduct of clinical research in a commercial context and also provide information on the types of medical technology commercial research. This chapter will describe the role that regulatory affairs has in the medical technology industry and describe the types of regulatory approval for medical devices.
State the types of medical technology commercial research.
Understand the unique requirements for sponsored research.
Describe the high-level types of regulatory approval for medical devices.
Understand the purpose and conduct of clinical research in a commercial context.
Describe the roles, responsibilities, and function of regulatory affairs in medical technology industry.
George Dungan, MPhil, MEd
Chapter 5- Applied Statistics
This chapter will provide the learner with knowledge to select the appropriate statistical test to describe variables and when comparing differences and detecting associations between variables. This chapter will also provide the learner with knowledge in regards to determining effect size and interpretation of common statistical tests.
Identify the correct statistical test for comparing differences and detecting associations.
Select the appropriate statistical test to describe variables in a study sample.
Interpret the results of common statistical tests for statistical significance and practical significance.
Compute the effect size for common statistical tests.
Ellen Becker, PhD, RRT, RRT-NPS, RPFT, AE-C, FAARC
Chapter 6- Grant Proposal Development
This chapter will provide the learner with knowledge regarding possible sources for grant funding. This chapter will review the process for completing a needs assessment, how to develop a problem statement, and how to write goals and aims for a grant proposal. This chapter will review program and experimental design and discuss evaluation methods as well as discuss budget development.
Describe how to perform a needs assessment, develop a problem statement, and how to write the goals and specific aims for a proposal.
Describe the development of a program or experimental design, and evaluation methods.
Identify possible sources for grant funding.
Describe the process and requirements of budget development.
Jose Rojas, PHD, RRT, RPFT