The Clinical Research Program (CRP) is designed to provide students with knowledge and insight into the most recent developments in the clinical research field within the pharmaceutical industry. It emphasizes up-to-date knowledge of clinical research concepts and strategies and analysis of the day-to-day operations in clinical testing and all supporting activities. It covers the drug development process, ethics and regulations, responsibilities of conducting research with human subjects, recording, protocol development, data collection, analysis, monitoring, and auditing.
This program has been developed to meet the needs of two diverse groups:
- professionals with a background in health-related disciplines who wish to change careers;
- professionals with a background in science-related disciplines who wish to begin a career related to clinical research.
Career Opportunities
Graduates of this program find employment in positions such as Clinical Research Assistant/Coordinator, Data Entry professional, Clinical Trail Assistant/Associate, Quality Control Reviewer and Medical Writer. They may work as freelancers, for Contract Research Organizations (CROs), or as employees (of physcians, hospitals or pharmaceutical companies, for example).
The main functions performed by graduates are in entry level positions to:
- provide administrative support to clinical trials
- participate in the preparation of clinical trial protocols
- participate in the conduct of clinical trials while ensuring compliance with the clinical trial protocols
- manage data about trial participants and the investigational product using forms or databases provided
- prepare reports and summaries of data obtained
Graduates may not be involved in the administration of pharmaceutical products/placebos and may not perform a clinical role with patients in clinical trials but, given additional education and/or experience, may be promoted to positions in which these tasks are performed.
Program Outcomes
Upon successful completion of this program, students are able to:
- demonstrate an understanding of the drug development process and its regulation in various jurisdictions
- demonstrate an understanding of roles and responsibilities within the clinical research enterprise
- demonstrate a detailed understanding of the stages of clinical research from planning to implementation, monitoring and closeout
- apply knowledge of the ethical, regulatory, scientific and administrative considerations in clinical research
- describe the essentials of Good Clinical Practice (GCP) as applied to clinical research
- determine an appropriate clinical study design for a given new product
- prepare the key plans and documentation required for a given clinical study
Curriculum
CRP100
Clinic Trial Regulations
Availability
This course provides an overview of the regulatory framework for the conduct of clinical trials. Topics include the role of regulatory agencies in the approval of new drugs/devices, relevant clinical trial regulations, the clinical trial application process and an evaluation of global healthcare systems as a factor in the conduct of clinical trials.
CRP101
Introduction to Drug Development/Clinical Trials
Availability
This course introduces students to the process of drug discovery and development. Students are provided an overview of the relevance of preclinical trials, their purpose, roles, and the transition from pre-clinical to clinical trials. The essential studies necessary to initiate a clinical trial are introduced.
CRP102
Clinical Trials Design
Availability
A clinical trial, by definition, is a carefully planned and scientifically sound experiment. This course provides the student with an opportunity to learn and understand the regulatory and scientific rationale of designing, conducting, and successfully completing a clinical trial. The various trial design elements and their usage and suitability for particular phases, indications, and types of clinical studies will be discussed.
CRP103
Ethical, Legal and Reg. Compliance
Availability
This course offers an examination of ethical, legal and regulatory requirements in clinical research. Topics include protection of subjects; diverse and vulnerable populations; informed consent; privacy/confidentiality; the role of the Institutional Review Board (IRB), Institutional Ethics Committee (IEC) and Research Ethics Board (REB); and reporting of serious adverse events.
CRP104
Clinical Study Administration
Availability
This course provides an overview of the management and conduct of clinical trials and the staff involved in conducting clinical trial research. Topics include essential documents in the clinical trial, the need for SOPs and qualified staff, and process for adequate oversight of the clinical trial.
CRP105
Good Clinical Practice
Availability
This course provides an overview of the fundamentals of GCP. By the end of this subject students are able to: describe the purpose of GCP, review the responsibilities of Sponsors, Investigators, Institutional Review Board and Ethics Committees in the context of GCP and describe some of its practical applications.
CRP106
Monitoring Clinical Research
Availability
This course outlines the various milestones of clinical research in relation to monitoring of the clinical site. The course defines the sponsor’s and investigator’s perspective and expectations in clinical research. Students gain the knowledge to ensure the study site processes and procedures are compliant and that data collected meets quality standards. Students learn the overall management and organization elements required to monitor a study effectively.
CRP107
Clinical Research Project
Availability
Working in small groups, students select a project (they may choose from a list provided if they wish) and, given the scenario they have chosen, the group plans for the conduct of their clinical trial, taking into account the ethical, regulatory, scientific and administrative considerations. This course enables students to apply topics learned in the other seven subjects in the Clinical Research Certificate program to complete a consolidated clinical trial plan.
Entry Requirements
Entry in the Clinical Research Program is limited to individuals with:
- Baccalaureate degree in health sciences or life sciences, or
- a registered nurse, or
- individuals currently working in clinical research.
Prerequisites
It is your responsibility to ensure that program requirements and course prerequisites as outlined are met. Prerequisites are included for your academic protection. Knowledge of the prerequisite material is assumed by your instructor and instruction will proceed accordingly. Students lacking prerequisites not only jeopardize their own ability to succeed but present unnecessary interruption. If you lack appropriate prerequisites (or an advanced standing for the prerequisite course) you may be asked to withdraw or transfer to a more appropriate course with the risk of academic/financial penalty.
Contact
Program Contacts
Sabrina Ramkellawan
Part-time Program Coordinator
Sabrina.Ramkellawan@senecacollege.ca
416.491.5050 x26450
Part-time Program Coordinator
Sabrina.Ramkellawan@senecacollege.ca
416.491.5050 x26450
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