CRP113 - GCP - Good Clinical Practice and Ethics
| Semester | |
| School | |
| Last revision date | 2024-09-03 09:44:59.083 |
| Last review date | 2024-09-03 09:44:59.083 |
Subject Title
GCP - Good Clinical Practice and Ethics
Subject Description
This course provides an overview of the fundamentals of ICH E6: Good Clinical Practice and highlights the importance of this guidance in ensuring consistency and safety of participants partaking in drug trials. The importance of the ethics in conducting clinical research will also be discussed.
Credit Status
One credit toward the Clinical Research Graduate Certificate Program.
Learning Outcomes
Upon successful completion of this subject the student will be able to:
- Describe the purpose of ICH E6: Good Clinical Practice (GCP);
- Understand the responsibilities of Sponsors, Investigators, Institutional Review Board and Ethics Committees in the context of GCP;
- Describe how Good Clinical Practice will be applied in a clinical trial and its importance in the global clinical research framework;
- Gain an understanding of the key ethical requirements needed to ensure the rights of a participant are met and the importance of ethics review and the role ethics boards in protecting research participants.
Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).
Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.
Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.
Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.
Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.
Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.
By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.
Prerequisite(s)
None
Topic Outline
Course Outline
|
Week |
Date |
Topic |
Lecture Content / Assignments |
| Professor Zoom Sessions will take place virtually every Thursday from 9:30-10:00am starting Thurs September 12 (Zoom link). Student participation in these sessions will be graded. | |||
| 1 |
Sep 5 (recorded) |
History of Ethics and Clinical Research |
|
| 2 |
Sep 12 (recorded) |
Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) |
|
| 3 |
Sep 19 (recorded) |
Principles of ICH GCP + Institutional Review Board/Independent Ethics Committee (IRB/IEC) |
|
| 4 |
Sep 26 (recorded) |
Research Ethics and Informed Consent |
|
| 5 |
Oct 3 (synchronous / live lecture) 9:00-10:30am |
Guest Speaker: Matthew D’Ascanio, Director – Research Ethics Review Program, Clinical Trials Ontario (CTO) |
|
| 6 |
Oct 10 (recorded) |
Investigator Responsibilities |
|
| 7 |
Oct 17 (recorded) |
Sponsor Responsibilities |
|
| 8 | Oct 24 | No Class – Study Week | |
| 9 |
Oct 31 (recorded) |
Standard Operating Procedures (SOPs) + Confidentiality and Privacy in Research |
|
| 10 |
Nov 7 (recorded) |
Conflict of Interest (COI) and Research Integrity |
|
| 11 |
Nov 14 (synchronous / live lecture) 9:00-11:00am |
Case Study Presentations |
|
| 12 |
Nov 21 (synchronous / live lecture) 9:00-11:00am |
Case Study Presentations (continued) |
|
| 13 |
Nov 28 (recorded) |
Course Review | |
| 14 | Dec 5 | Exam | |
Mode of Instruction
This class will be via online instruction. Instruction will include lectures, audio-visual presentations, case studies, group work and in-class exercises. Students can expect to spend approximately 2-3 hours outside of class reading, doing assignments, etc.
Prescribed Texts
None
To find out the cost of books and learning material go here.
Any courses not listed on the bookstore webpage do not require any resources for purchase. All resources will be provided by your instructor.
Reference Material
- ICH E6(R2): Good Clinical Practice, available at: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) available at: https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html
- The Immortal Life of Henrietta Lacks by Rebecca Skloot – available via Seneca Libraries
Required Supplies
A device available to access Seneca Blackboard is required. This is typically fulfilled by a computer. A suitable internet connection to support a simultaneous audio and video stream is required.
.
Student Progression and Promotion Policy
Students much achieve grade average of greater than or equal to 50% in order to pass the class.
http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html
Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html
| A+ | 90% to 100% |
| A | 80% to 89% |
| B+ | 75% to 79% |
| B | 70% to 74% |
| C+ | 65% to 69% |
| C | 60% to 64% |
| D+ | 55% to 59% |
| D | 50% to 54% |
| F | 0% to 49% (Not a Pass) |
| OR | |
| EXC | Excellent |
| SAT | Satisfactory |
| UNSAT | Unsatisfactory |
For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices. (https://www.senecapolytechnic.ca/registrar.html)
Modes of Evaluation
| ePosterBoard | 15% |
| Case Study | 15% |
| Class Participation | 10% |
| Quizzes (4) | 20% (5% each) |
| Exam | 40% |
| TOTAL | 100% |
General School Policies
Term Work and Final Exam
Students much achieve grade average of greater than or equal to 50% in order to pass the class.
Assignments
Assignments are due at the beginning of the class on which they are due. A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due. Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first. Assignments are to be prepared/submitted by computer via Blackboard unless otherwise specified.
Absenteeism and Exams
Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date. Official documentation includes a death notice or an original doctor's certificate identifying the date, length of time expected absence and the specific reason for the absence. Examinations missed without official documentation and approval result in a grade of zero.
There are no deferred options for missed tests. The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components.
English Proficiency
All written work should demonstrate the following characteristics for clarity and conciseness:
- writing is consistent with the rules of English grammar
- spelling and punctuation are correct sentences are structured correctly
- main ideas are supported with specific, relevant examples and reasons, work flows logically through supporting statements/paragraphs
- work is arranged in correct format (e.g., as a report, essay)
- up to 10% of the final grade may be deducted on all work if the above English competencies are not met.
Students must use the standard, APA style for referencing sources. Help is available at: http://library.senecapolytechnic.ca.
Academic Integrity
Seneca Polytechnic takes Academic Integrity very seriously. Therefore, all assignments in this course must be completed independently (unless otherwise stated), and with integrity. Copying and pasting from any source without correct quoting, paraphrasing, and citations will be considered plagiarism. This or any other contravention of Seneca's Academic Integrity Policy, including cheating, sharing, collusion, using Spinbots, Contract Cheating, Falsification, Impersonation, submitting a previously-submitted assignment, or unauthorized use of translator and Artificial Intelligence Generated Content will be reported to the Academic Integrity Committee. Please review the Academic Integrity Policy.