Master of Science in Health Research Management

The course is designed to train participants in how to effectively manage clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and regulatory issues encompassing Saudi Food and Drug Administration (SFDA) and National Committee of Bioethics (NCBE). This course will be of significant interest and value to graduate students and other health care professionals planning post-graduate training.

This course provides a broad exposure to basic principles and practices of the Saudi Food, Drug, Medical devices, Cosmetics, and Pesticides Act regulating the research and development of pharmaceuticals and biologics for humans and animals. It will include an analysis of legal and social framework affecting academic clinical investigators and the industry with emphasis on MOH and SFDA enforcement actions. Discussions will cover the specific, general, and global issues associated with these laws and regulatory topics.  Several field trips and site visits are scheduled during the course to reinforce understanding of the selected topics.

This course provides a broad exposure to introduction to pharmaceutical industry, process of drug development, and drug development phases (1-4). Regulatory requirements of the Saudi Food and Drug Administration (SFDA) and FDA are reviewed along with the content of the investigational new drug application (IND), new drug application (NDA), marketing authorization application (int’l), and the pharmaceutical regulatory affairs. The course emphasis will be on drug development in addition to development of biologics, OTC, and devices. This course focuses on drug discovery through IND submission and clinical development including portfolio decision-making. The roles and responsibilities of the principal investigator, coordinator, sponsor, and monitor are discussed.

This course is designed to encourage well-informed critical discussions of ethical issues in research management. Scientific considerations in research management policy and interventions occasionally cause political and ethical conflicts. Issues of autonomy, individual rights, coercion, justice, community, and multicultural values are pivotal in ethical research. A population-based perspective of research management goals should be ethically balanced with the preservation of human rights and protection of civil liberties. Goals of this course are: Stimulating the moral imagination, recognizing ethical issues, developing analytical skills, eliciting a sense of moral obligation and responsibility, and coping with moral ambiguity. The course will enable students to recognize, analyse, criticize, and evaluate ethical issues and equip them with practical knowledge to construct arguments and make decisions in research management

This course provides an in-depth analysis of clinical research financial regulations, budget process, clinical trial revenue cycle, and patient remuneration. This course describes the significance of ensuring that the investigator and study team are integrated into the financial components of the study to mitigate the risks associated with non-compliance with research billing regulations. Students will understand and be able to apply concepts of financial management, decision-making, and quality assessment to health systems and be able to develop broad policy statements concerning research management. Strategies for developing operational efficiencies and establishing communication channels to enhance sponsor reimbursements will also be discussed.

This course provides an in-depth analysis of effective leadership skills encompassing specific human capital, organizational behaviour and project management issues facing research facilities as larger, integrated organizations. Selected topics include high impact communications, negotiating, motivation and recognition. A detailed overview of research leadership and quality management systems, regulations and guidelines has been provided. Development and management of total quality systems meeting regulatory expectations has been highlighted.   The covered topics include development, management, usage/maintenance of Standard Operating Procedures (SOPs), deviation/non-conformance systems, corrective/preventative action systems, validation, and process controls via key performance indicators to ensure quality in research.

This course is designed for students pursuing the Masters in Clinical Research Coordinator program,
offering an in-depth exploration of advanced pharmacological research methods and practices. This
course provides a comprehensive understanding of the critical components involved in pharmaceutical
research, including drug development, epidemiological considerations, pharmacoeconomics, medication
safety, and regulatory affairs. Through a combination of theoretical knowledge and practical application,
students will acquire the skills and ethical values required to excel in coordinating, managing, and
conducting pharmacological research. This course empowers students to contribute to the advancement
of pharmaceutical science and the improvement of healthcare outcomes.

The course is designed to equip students with the essential skills required for effective scientific and
medical communication. Through a series of comprehensive modules, students will gain proficiency in
research proposal writing, literature search strategies, ethical considerations, manuscript preparation, and
publication practices. This course empowers students to become adept in articulating their research
findings, ensuring compliance with ethical standards and authorship criteria, and contributing to the
dissemination of scientific knowledge.

This course is designed to provide students with a comprehensive understanding of screening and
diagnostic tests in medicine. Through a series of in-depth modules, students will explore the principles,
methodologies, and ethical considerations involved in effective screening and diagnosis. This course
equips students with the knowledge, skills, and ethical values necessary to excel in coordinating,
managing, and conducting screening and diagnostic studies, ensuring the highest standards of patient
care and research integrity.

This course is an integral part of the Masters in Clinical Coordinator program and provides a
comprehensive exploration of the intersection between bioinformatics and health economics within the
context of clinical coordination. Students will delve into the intricate relationship between data-driven
insights and economic principles, developing a strong foundation for effective decision-making in
healthcare. Through a blend of theoretical knowledge and practical applications, participants will gain the
skills and expertise needed to excel in this dynamic field.

Students completing a Thesis Option master’s degree are expected to write a report, referred to as a thesis, on the results of an original investigation, in conjunction with a Master’s Advisory Committee. Length and style of the thesis vary by college/department. All these are filed with the Office of Graduate Studies. A Master’s Advisory Committee will be formed for each student and will consist of three members; an Alfaisal faculty member as the Major Advisor and Chair, and two other members, one of whom may be from an organization outside of the University. The Chair of the Committee must have research and graduate student advising experience. This Committee will assist the student in the formulation of the Thesis Project Proposal, and later advise the student in the execution of the research project, the Thesis write-up, and help the student to prepare for the oral defense.

Students completing a Thesis Option master’s degree are expected to write a report, referred to as a thesis, on the results of an original investigation, in conjunction with a Master’s Advisory Committee. Length and style of the thesis vary by college/department. All these are filed with the Office of Graduate Studies. A Master’s Advisory Committee will be formed for each student and will consist of three members; an Alfaisal faculty member as the Major Advisor and Chair, and two other members, one of whom may be from an organization outside of the University. The Chair of the Committee must have research and graduate student advising experience. This Committee will assist the student in the formulation of the Thesis Project Proposal, and later advise the student in the execution of the research project, the Thesis write-up, and help the student to prepare for the oral defense.

Students completing a Thesis Option master’s degree are expected to write a report, referred to as a thesis, on the results of an original investigation, in conjunction with a Master’s Advisory Committee. Length and style of the thesis vary by college/department. All these are filed with the Office of Graduate Studies. A Master’s Advisory Committee will be formed for each student and will consist of three members; an Alfaisal faculty member as the Major Advisor and Chair, and two other members, one of whom may be from an organization outside of the University. The Chair of the Committee must have research and graduate student advising experience. This Committee will assist the student in the formulation of the Thesis Project Proposal, and later advise the student in the execution of the research project, the Thesis write-up, and help the student to prepare for the oral defense.