Clinical Research

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Courses - January 2024

Level 1

Course details

Effective Communication in Clinical Research
COMM8540

Description:

Effective communication is vitally important in clinical research. Whether communicating the research results to the public, publishing in a scientific journal, explaining the risks to the study participants, or completing a regulatory compliance document, clinical research professionals engaging and recruiting within the patient community, must communicate in a clear, effective and compelling manner. In this course, the students will gain the foundational skills of communicating with a variety of stakeholders across different clinical research settings. Through hands-on projects, students will learn how to prepare different styles of written and spoken communications related to clinical research, and how to tailor the communication strategy based on the purpose and audience.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Conestoga 101
CON0101

Description: This self-directed course focuses on introducing new students to the supports, services, and opportunities available at Conestoga College. By the end of this course, students will understand the academic expectations of the Conestoga learning environment, as well as the supports available to ensure their academic success. Students will also be able to identify on-campus services that support their health and wellness, and explore ways to get actively involved in the Conestoga community through co-curricular learning opportunities.
  • Hours: 1
  • Credits: 0
  • Pre-Requisites:
  • CoRequisites:

Good Clinical Practice and Research Ethics
ETHS8070

Description:

Clinical Research involving humans needs to adhere to a stringent framework of regulations and practices to ensure safe and ethical treatment of participants. In this course students learn to apply the regulation on clinical trials and the principles of Good Clinical Practice (GCP) as described by the International Conference on Harmonization to various clinical research context. Students also learn the fundamentals of ethics and ethical treatment of participants, including culturally safe and appropriate health research practices.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Managing Clinical Research
MGMT8335

Description:

Accuracy and reliability of clinical documentation is of paramount importance to the success of clinical research. In this course students learn to create effective documentation management processes and gain expertise in applying guidelines to accurate and reliable documentation. In particular, students will learn to properly use REDCap, Excel, R programming and data management via the cloud to ensure proper data transfer and integrity as well as maintain strict patient privacy. Students gain expertise in preparing a variety of clinical research documents in accordance with the ALCOA (attributable, legible, contemporaneous, original and accurate) criteria.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Clinical Quality Assurance Foundations
QUAL8460

Description:

This course introduces the concept of Quality Assurance as it applies to clinical settings. By examining Quality Assurance theory, students learn to apply best practices in Quality Assurance to their context. Students learn to apply Standard Operating Procedures (SOP) throughout the lifecycle of a clinical trial to ensure integrity, efficiency and compliance.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Introduction to Clinical Research
RSCH8170

Description:

In this course, students develop the foundational concepts underpinning clinical research. Students will be exposed to the foundations of clinical research in drug, device, biologics and intervention development. Using the knowledge of clinical research foundations, the students build skills to appropriately support clinical research initiation and management to bring it to successful completion.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Clinical Research Regulation
RSCH8210

Description:

Regulation plays a crucial role in protecting public safety and conducting clinical trials. In this course, students will determine the ethical, scientific, and legal aspects of the regulatory framework for conducting clinical research by analyzing and implementing the guidelines for Good Clinical Practice (GCP). In addition, students will gain an understanding of how regulatory agencies such as Health Canada, FDA, and EMA monitor and inspect clinical research around the world. Finally, using the knowledge and skills gained throughout the course, students will propose a novel clinical research project, prepare a clinical trial application, demonstrate compliance with a regulatory body, and simulate a data submission report to disseminate the clinical results of their project.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Clinical Laboratory Procedures: Microbiology, Physiology, and Pharmacology
RSCH8220

Description:

In this course, students build a foundational understanding of clinical laboratory processes underpinning clinical research. The course focuses on the importance of Good Laboratory Practices and regulatory framework in clinical data acquisition, recording, and reporting. During laboratory experience, students will become familiar with collecting, processing, and analyzing clinical data related to microbiology, physiology, and pharmacology. In addition, students will develop and implement Standard Operating Procedures that align with quality assurance principles and comply with applicable regulatory frameworks and best practices. The course also explores the use of artificial intelligence in data collection and verification, diagnostics, and drug development in clinical research trials.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Level 2

Course details

Career Management
CDEV8132

Description: This course focuses on career management skills needed to navigate the evolving workplace. Students will evaluate their skills, attitudes, and expectations within their chosen careers and explore emerging trends in the workplace. Students will refine their networking strategies and create marketing documents to position them for success. Mock interviews will provide the opportunity for practice, feedback, and reflection as students prepare for future interviews. Students will explore communication strategies that support workplace success and advancement. By the end of this course, students will have created a personalized career management plan.
  • Hours: 28
  • Credits: 2
  • Pre-Requisites:
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Clinical Research Data Management and Biostatistics
RSCH8230

Description:

This course provides a foundation of data management and biostatistical concepts in clinical research using different software programs including R programming, Excel, PRISM, and others. Students learn the process of identifying, collecting and analyzing data in the context of clinical research. Students apply concepts of data management and biostatistics to develop a data management plan and conduct common statistical analyses and interpretations to support reporting and manuscript development.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Clinical Trial Design and Administration
RSCH8240

Description:

Clinical trials are an essential step in the development of a new drug, medical device or intervention. In this course students learn the fundamentals of clinical trial design, including instructions on how to design a clinical protocol, clinical trial phases, randomization and blinding, ethics and regulatory compliance. Students will use examples for pharmaceutical development, medical devices, or treatment protocols, to apply the concepts from this course to propose a clinical trial design.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Epidemiological Studies Design and Administration
RSCH8250

Description:

Epidemiological studies allow researchers to study health in populations to understand the causes and patterns of health and illness. In this course students learn different types of epidemiological studies and the fundamentals of epidemiological studies design. Using problem-based learning, students apply the concepts of epidemiological study design and principles of culturally safe clinical research to propose a public health study. Students also learn the implications of epidemiological studies on public health policy.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Clinical Research Project Management
RSCH8260

Description:

The increasing complexity of clinical research places demands on clinical researchers to efficiently manage work in clinical settings. This course equips students with foundational project management skills as applied to clinical research settings. Students learn how to develop project plans, timelines, budget tracking, stakeholder engagement and risk logging.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
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Artificial Intelligence in Clinical Research
RSCH8270

Description:

Artificial intelligence (AI) and, in particular, machine learning tools are powerful technologies for any clinical research setting. In this course the students will learn how to leverage machine learning and artificial intelligence to guide trial feasibility testing and trial development, manage large volumes of data, facilitate inter-team collaboration, improve data quality and provide checks to ensure accuracy and clarity. Students will also learn the strengths and weaknesses of current AI software and tools, and will learn to create training and test data sets, along with alternative tools (e.g. deep learning) used in a clinical research setting.

  • Hours: 42
  • Credits: 3
  • Pre-Requisites:
  • CoRequisites:

Clinical Research Capstone
RSCH8280

Description:

Using a real-world example from a pharmaceutical, device, cannabis, agricultural, natural product or biotechnology industries, student apply clinical research design and administration skills to plan, design and prepare a clinical research proposal. Students apply knowledge and skills in regulation, ethics, documentation management and project management to create a clinical research proposal.

  • Hours: 84
  • Credits: 6
  • Pre-Requisites:
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Program outcomes

  1. Develop, implement and maintain processes and Standard Operating Procedures to execute clinical research projects that align with principles of quality assurance and comply with applicable regulatory frameworks and best practices.
  2. Communicate and collaborate with relevant stakeholders to complete research studies according to requirements.
  3. Collect, verify and oversee the integrity of research data from acquisition to recording.
  4. Monitor project progress to proactively resolve project related challenges to mitigate risks and improve quality of projects.
  5. Obtain and maintain required ethical and regulatory approvals to ensure the protection and safety of clinical trial participants and the integrity of research data.
  6. Manage the operations of research projects to ensure compliance and completion within time and budget constraints.
  7. Identify and apply strategies to support culturally safe research settings involving diverse communities.
  8. Participate in professional development activities to maintain currency and compliance in a changing clinical research industry.
  9. Employ artificial intelligence, such as machine learning to guide clinical research development, improve data, and provide quality checks to ensure accuracy and efficiency