Lifelong Learning for a Brighter World

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Applied Clinical Research

Imagine Better Health.

Your key to entering the rewarding field of clinical research.

ACR 104 - Clinical Trial Management C22 (Online)

Academic Credit Value:
3 units
Course Delivery Mode:
Online
Hours of Study:
39 hours
Course Prerequisite(s):
ACR 103: Clinical Trial Design
Course Anti-requisite(s):
N/A
Instructor Name:
Lawrence Reiter
Course Dates:
06/07/2021 - 08/29/2021



Required Course Materials:
N/A - All course materials will be available in Avenue to Learn
Optional Course Materials:
N/A
Course Description:
Strategies for conducting and managing clinical trials, as well as operational issues of a clinical research project will be examined. Effective methods for organizing data and quality assurance will be explored as well as end of trial practices, safety reporting, and the preparation of scientific documents. Topics in leadership will also be examined including management of resources, risk and professional conflicts.
Learning Outcomes:

Upon completion of this course, students will:

  • Evaluate the processes associated with planning and managing a clinical trial.
  • Identify strategies to mitigate and manage risk in clinical trials.
  • Develop procedures to ensure quality management practices in clinical trials.
  • Create project management and planning tools to operationalize a clinical trial.
  • Describe data flow and mechanisms to organize and verify data in clinical trials.
  • Identify strategies for patient engagement in clinical trials.
Course Evaluation

The final grade is calculated based on the following components:

Quizzes: 20%
Discussions: 15%
Assignment 1 -  Clinical Trial Site Budget and Payment Schedule 25%
Assignment 2: - Manual of Operations 25%
Assignment 3 -  Data Flow and Organization 15%

Course Survey/Evaluations
Students are required to provide feedback by completing course reaction/evaluation surveys.  Course evaluations are administered through an online resource.  Course instructors are not involved in the distribution or collection of course evaluations.  In all cases, students will remain anonymous.
Course Format:
This course is designed to present the fundamental concepts and theories in clinical research and promote the application to the workplace and professional practice. Course activities will include instructor presentations, required readings and experiential learning activities (i.e. case studies, group discussions, projects, etc.).
Assignment Submission:
Course assignments are submitted to the appropriate A2L Assignment folder by the specified due date
Late Coursework:
Late assignments will be subject to a 2% per day late penalty (includes weekends and holidays) for up to seven (7) days. After this date, no assignments will be accepted and a grade of zero (0) will be applied. Extensions for course work must be approved by the instructor before the due date (see Academic Regulations below), and will be granted for illness or emergencies only. Students may be asked to submit supporting documentation for an extension request.  

Policy & Procedures:

Academic Regulations (Attendance, Coursework, Tests/Exams):

In accordance to McMaster University’s General Academic Regulations, “it is imperative that students make every effort to meet the originally scheduled course requirements and it is a student’s responsibility to write examinations as scheduled.” Therefore, all students are expected to attend and complete the specific course requirements (i.e. attendance, assignments, and tests/exams) listed in the course outline on or by the date specified. Students who need to arrange for coursework accommodation, as a result of medical, personal or family reasons, must contact the course instructor within 48 hours of the originally scheduled due date. It is the student’s responsibility to contact the Program Manager to discuss accommodations and procedures related to deferred tests and/or examinations within 48 hoursof the originally scheduled test/exam, as per policy. Failure to contact the course instructor, in the case of missed coursework, or the Program Manager, in thecase of a missed test/examination, within the specified 48-hour window will result in a grade of zero (0) on the coursework/exam and no further consideration will be granted.

*Note: Supporting documentation will be required but will not ensure approval of accommodation(s).

Academic Integrity
(Please note that CCE will adhere to a zero tolerance application of the policy)

You are expected to exhibit honesty and use ethical behaviour in all aspects of the learning process. Academic credentials you earn are rooted in principles of honesty and academic integrity.  Academic dishonesty is to knowingly act or fail to act in a way that result or could result in unearned academic credit or advantage. This behaviour can result in serious consequences, e.g. the grade of zero on an assignment, loss of credit with a notation on the transcript (notation reads: “Grade of F assigned for academic dishonesty”), and/or suspension or expulsion from the university.

It is your responsibility to understand what constitutes academic dishonesty. For information on the various types of academic dishonesty please refer to the Academic Integrity Policy, located at www.mcmaster.ca/academicintegrity.

The following illustrates only three forms of academic dishonesty:

  1. Plagiarism, e.g. the submission of work that is not one’s own or for which other credit has been obtained, including copying solution sets.
  2. Improper collaboration in group work.
  3. Copying or using unauthorized aids in tests and examinations.
Academic Accommodations:
Students with disabilities who require academic accommodations must contact the Student Accessibility Centre (SAS) to meet with an appropriate Disability Services Coordinator. To contact SAS, phone 905-525-9140 ext. 28652, or email sas@mcmaster.ca. For further information, consult McMaster University’s Policy for Academic Accommodation for Students with Disabilities.

Academic Accommodation for Religious, Indigenous or Spiritual Observances (RISO)
Students requiring academic accommodation based on religious, indigenous or spiritual observances should follow the procedures set out in the RISO policy. Students will need to contact their instructors as soon as possible to make alternative arrangements for classes, assignments, and other coursework. It is the student’s responsibility to contact McMaster Continuing Education to discuss accommodations related to examinations. (if applicable)
On-line Elements:

In this course, we will be using on-line elements, which may include email, Avenue to Learn, WebEX, and external web sites.  To access Avenue to Learn go to: http://avenue.mcmaster.ca You will be required to enter your MAC ID (login and password). To activate your MAC ID, contact University Technology Services. Students should be aware that, when they access the electronic components of this course, private information such as first and last names, user names for the McMaster e-mail accounts, and program affiliation may become apparent to all other students in the same course. The available information is dependent on the technology used. Continuation in this course will be deemed consent to this disclosure. If you have any questions or concerns about such disclosure please discuss this with the course instructor. ​

Conduct Expectations:
As a McMaster student, you have the right to experience, and the responsibility to demonstrate, respectful and dignified interactions within all of our living, learning and working communities. These expectations are described in the Code of Student Rights & Responsibilities (the “Code”). All students share the responsibility of maintaining a positive environment for the academic and personal growth of all McMaster community members, whether in-person or online.

It is essential that students be mindful of their interactions online, as the Code remains in effect in virtual learning environments. The Code applies to any interactions that adversely affect, disrupt, or interfere with reasonable participation in University activities. Student disruptions or behaviours that interfere with university functions on online platforms (e.g. use of Avenue 2 Learn, WebEx or Zoom for delivery), will be taken very seriously and will be investigated. Outcomes may include restriction or removal of the involved students’ access to these platforms.


Copyright and Recording:
Students are advised that lectures, demonstrations, performances, and any other course material provided by an instructor include copyright protected works. The Copyright Act and copyright law protect every original literary, dramatic, musical and artistic work, including lectures by University instructors.

The recording of lectures, tutorials, or other methods of instruction may occur during a course. Recording may be done by either the instructor for the purpose of authorized distribution, or by a student for the purpose of personal study. Students who wish to record sessions need to acquire permission from the instructor. Students should be aware that their voice and/or image may be recorded by others during the class. Please speak with the instructor if this is a concern for you.
Turnitin.com:
In this course, we will be using a web-based service (Turnitin.com) to reveal plagiarism.  Students will be expected to submit their work electronically to Turnitin.com so that it can be checked for academic dishonesty.  Students who do not wish to submit their work to Turnitin.com must still submit a copy to the assigned Assignment folder and add a note in the comment section that they do not wish to have the paper scanned by Turnitin.  Those files will not be selected for submission.  No penalty will be assigned to a student who does not submit work to Turnitin.com.  All submitted work is subject to normal verification that standards of academic integrity have been upheld (e.g., on-line search, etc.).  To see the Turnitin.com Policy, please go to McMaster Acedemic Integrity Policy
Course Changes:
The instructor reserves the right to modify elements of the course and will notify students accordingly.

Extreme Circumstances:
The University reserves the right to change the dates and deadlines for any or all courses in extreme circumstances (e.g., severe weather, labour disruptions, etc.). Changes will be communicated through regular McMaster communication channels, such as McMaster Daily News, A2L and/or McMaster email.
Course Withdrawal Policy:

Policies related to dropping a course and course withdrawals are posted to the Centre for Continuing Education’s program webpage, FAQs & Policies (/academic-faqs).  

Students withdraw from courses in MOSAIC's student center (do not send withdrawal request email to CCE).

Grading Scale:
A+ = 90  -  100 %
A = 85  -   89 %
A- = 80  -   84 %
B+ = 77  -   79 %
B = 73  -   76 %
B- = 70  -   72 %
C+ = 67  -   69 %
C = 63  -   66 %
C- = 60  -   62 %
D+ = 57  -   59 %
D = 53  -   56 %
D- = 50  -   52 %
F = 0    -   49 %
Course Schedule:
Topic & Readings

Module 1: Clinical Research Infrastructure
Module 2: Project Management in Clinical Trials
Module 3: Clinical Trial Budgets and Contracts
Module 4: Quality in Clinical Trials
Module 5: Clinical Trial Planning and Operations
Module 6: Clinical Trial Start-up
Module 7: The Day-to-Day Conduct of a Clinical Trial
Module 8: Clinical Trial Data Flow and Organization
Module 9: Operational Challenges in Clinical Trials
Module 10: Patient Engagement in Clinical Trials