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:
1.
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;
2.
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;
3.
Summarize the specific processes in line with regulatory and legislative framework
that ensures safety, efficacy, and quality for regulatory authority approval of the
marketing authorization for a medical product;
4.
Understand the framework of global clinical operations as it relates to good clinical practice, study conduct, and management; safety profile management and control
and handling of investigational product;
5.
Identify and explain the specific procedural, financial, documentation, and oversight
requirements of PIs, sponsors, site personnel, contract research organizations, and regulatory authorities related to the conduct of a clinical trial;
6.
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, correction, and queries;
7.
Identify and implement the practice of leadership and project management of the
ethical and professional conflicts that are associated with the conduct of clinical
research and project strategy; and
8.
Discuss the various elements of communication between 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
conducting a clinical trial.
For those students in the drug safety and pharmacovigilance track, students will be able
to:
1.
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;
2.
Summarize 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;
3.
Summarize the specific drug safety function and processes in line with regulatory
and legislative frameworks that ensure 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;
4.
Understand the framework of drug safety and pharmacovigilance operations as
it relates to U.S. and EMA rules, regulations and initiatives governing both safety
reporting (ICSR and aggregate reports) and processing data from clinical trials and
postmarketing environments, including CIOMS and ICH guidelines;
5.
Explain the development and maintenance of Pharmacovigilance System Master
File, Safety Management Plans, and Safety Data Exchange Agreements across clinical
study programs and postmarketing activities;
6.
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 postmarketing safety data;
7.
Perform risk identification (signal detection) and characterize identified risks,
potential risks based on signal analysis to develop a risk management plan;
8.
Identify the different risk management tools such as RMPS and REMS;
9.
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; and
10.
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.
