Catalog Navigator : Program Learning Outcomes

The goals and objectives of the program vary depending on track selected.

For students in the clinical research management track, students will be able to:

Clinical Research Management
The core program covers the theory and practice of research methods, statistics, regulatory and legal frameworks for clinical investigation, drug development, clinical research operations, project management, leadership skills, disease process, and regulatory writing. Students take additional courses defining their area of specialization in patient engagement, advertising and labeling, medical devices, international regulatory affairs, medical affairs, or clinical data management. This track is designed for the clinical researcher who has some experience working in the pharmaceutical industry or academic medical center. However, novice individuals may also consider this option.

Upon completion of the MS Clinical Research management program, student should be able to:

Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
Conduct informed consent, maintain privacy, and apply principles of human subject protections at all stages in drug and device development. Describe how historical events with regards to subject protection informed changes in the code of federal regulations and other regulatory documents.
Plan and implement trial related activities in accordance with regulatory and legislative guidances to ensure safety, efficacy and quality in a clinical trial.
Apply Good Clinical Practice with regards to study conduct and management, safety profile management, and the control and handling of investigational products to national and global trials.
Construct appropriate communications as they pertain to IRB application, FDA and global regulatory agencies, budget negotiations, and other filing opportunities.
Explain and interpret the flow of study data through electronic data capture programs, and participate in data correction and queries.
Implement leadership and project management strategies to solving ethical and professional conflicts associated with the conduct of clinical research.

For those students in the academic clinical research management track, students will be able to:

Academic Clinical Research Management
This track is especially designed for students with no clinical research or pharmaceutical experience who would like to participate in clinical research at an Academic Medical Center (AMC) functioning as a żstudy coordinator.ż It covers the theory and application of research methods, basic statistics, regulatory and legal governances over clinical trials and the conduct of clinical research performed at research intensive institutions. Pathophysiology and pharmacological outcomes as well as project management, prepare the novice practitioner to become a Clinical Research Coordinator specializing in clinical operations at AMCs.

Upon completion of the MS Clinical Research Management-Academic Clinical Research program students will be able to:

Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process.
Implement regulatory and legislative guidances and regulations that ensure safety, efficacy and quality for regulatory authority approval for the marketing authorization for a medical product.
Identify red flags indicating ADRs may be present.
Conduct consenting processes across a variety of research participants.
Identify and explain the specific procedural, financial and regulatory documentation including IRBS, clinical trial agreements, and regulatory inspections of site personnel related to the conduct of a clinical trial.
Describe how data sets the stage as a critical role in a clinical trial including electronic data capture, the importance of information technology in data collection, capture, management, and queries.
Identify and implement the project management that are associated with the conduct of clinical research and project strategy.
Develop a patient recruitment plan.

For those students in the drug safety and academic clinical research management track, students will be able to:

Drug Safety and Pharmacovigilance
This track focuses on drug safety basics and regulations, risk management, and signal detection, as well as the core elements of theory and practice of research methods, regulatory requirements of clinical investigations, disease process and pharmacology. It is designed for the drug safety professional who has minimal knowledge in the pharmacovigilance area.

Upon completion of the MS Clinical Research Management-Drug Safety and Pharmacovigilance program students will be able to:

Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization safety management, as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints.
Utilize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety science to analyze potential safety issues and understand the patient population and the risks in the drug development process.
Summarize the specific drug safety function and processes in line with regulatory and legislative framework that ensures safety and quality though the various phases that must be followed in order for the regulatory authority to approve the marketing authorization for a medical product.
Implement drug safety and pharmacovigilance operations as it relates to US and EMA rules, regulations and initiatives governing both safety reporting (ICSR and aggregate reports) and processing data from clinical trials, and post-marketing environments including CIOMS and ICH guidelines.
Develop and maintain Pharmacovigilance System Master Files, Safety Management Plans and Safety Data Exchange Agreements across clinical study programs and post marketing activities.
Identify the data sources, data capture, data assessment (seriousness; labeledness/expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data.
Perform risk identification (signal detection) and characterize identified risks, potential risks based on signal analysis to develop a risk management plan.
Analyze data obtained from the different Risk Management Tools such as RMPS and REMS.
Identify and implement the practice of leadership and project management through the role of key drug safety professionals with the drug safety function associated with the conduct of clinical research, product strategy and responding to regulatory authority inquiries.
Discuss the various elements of communication for a cohesive quality management system including effectively preparing and conducting audits and inspections across the site and sponsor, health authorities and contract research organizations as well as within the site through the understanding of multidisciplinary teamwork skills necessary for collecting and querying safety data in a clinical trial.