CRP101 - Introduction to Drug Development/Clinical Trials
Semester | |
School | |
Last revision date | 2024-09-19 08:36:03.914 |
Last review date | 2024-09-19 08:36:03.914 |
Subject Title
Introduction to Drug Development/Clinical Trials
Subject Description
This course provides an overview of the entire drug discovery and development process, from the considerations that go into deciding which drugs to develop to the final stages of clinical trials. The key concepts are covered and defined. Students will gain insight into the steps undertaken to bring a new drug to development.
Credit Status
One credit toward the Clinical Research Certificate Program
Learning Outcomes
Upon successful completion of this subject the student will be able to:
1. Describe the key steps in drug discovery
2. Outline and understand the phases of clinical trials
3. Define key concepts in clinical trials and drug development
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
Week | Content | Evaluation |
1 Sep 9, 2024 | Drug Discovery and Development: An Overview | |
2 Sep 16, 2024 | Drug Discovery and Development, con’t | |
3 Sep 23, 2024 | Safety Review | |
4 Sep 30, 2024 | Efficacy Review | |
5 Oct 7, 2024 | Human Equivalent Dose and Clinical Trial Phases | |
6 Oct 14, 2024 | Clinical Studies 1 (no live class – lecture recording) This lecture material is not part of the mid-term test | |
Study Week | ||
7 Oct 28, 2024 | Assignment #1 | 15% of final mark |
8 Nov 4, 2024 | Mid-term Test | 25% of final mark |
9 Nov 11, 2024 | Clinical Studies 2 | |
10 Nov 18, 2024 | Post-Marketing Surveillance, Bioequivalence and Clinical Studies | |
11 Nov 25, 2024 |
Patents and Intellectual Property Introduction to Safety Science |
|
12 Dec 2, 2024 | Assignment 2 | 15% of final mark |
13 Dec 9, 2024 | Final Exam | 35% of final mark |
Mode of Instruction
Online – classes will occur synchronously via Zoom
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
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines available https://database.ich.org/
Required Supplies
Students must have access to a computer with access to a current browser able to utilize Blackboard and Zoom online meeting platform. Access to a suitable internet access with the ability to stream audio and video simultaneously is required.
Student Progression and Promotion Policy
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..
Modes of Evaluation
Evaluation: | Percentage of Final Grade |
Assignment # 1 | 15% |
Mid-term Test | 25% |
Assignment #2 | 15% |
Final Exam | 35% |
Professionalism | 10% |
General School Policies and Guidelines
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.