CRP104 - Clinical Study Administration

Prerequisite(s)
None

Topic Outline
1. Introduction to clinical research administration
2. Introduction to project management
3. ICH-GCP Essential documents
4. Regulatory compliant documentation practices
5. Development of a clinical study protocol
6. Informed consent document development
7. Source documents and case report forms
8. Investigational brochures
9. Standard operating procedures
10. Clinical research team member responsibilities and training
11. Subject recruitment strategies
12. Study management (eligibility, enrollment, protocol violations, visits and supplies)
13. Adverse event reporting
 

Mode of Instruction
Lectures, audio-visual presentations, case studies, group work, in-class exercises. A laptop is required for this course and can be borrowed from the Seneca Libraries. Students can expect to spend approx. 2-3 hours outside of class reading, doing assignments, etc.  

Prescribed Texts

There are no required text books for this class, however, there are many references that we will be using throughout, here are some valuable sources of information:
HC Division 5 Part C - Regulations amending the food and drug regulations http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/reg/1024-eng.php
Health Canada ICH GCP E6 - Good Clinical Practices: Consolidated Guideline http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e6-eng.pdf
FDA 21 CFR Part 50 - Protection of Human Subjects http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=50&showfr=1
HC Guide-0068 - Guidance for Records Related to Clinical Trials http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gui_68-eng.pdf
FDA 21 CFR Part 11 - Electronic Records: Electronic Signatures http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1
Health Canada - Clinical Trials Manual http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_intro-eng.php
Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]
Belmont Report http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4178b_09_02_Belmont%20Report.pdf
Nuremberg Code http://en.wikipedia.org/wiki/Nuremberg_Code

Class handouts and notes
 

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
None

Required Supplies
None

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

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


• Assignment #1 - 20%
• Mid Term Exam - 25%
• Assignment #2 -  20%
• Final exam: 35%

Essential Employability Skills:
• Apply a systematic approach to solve problems.
• Written and verbal communication skills conveying medical information relevant to clinical research
• Locate, select, organize, and document information using appropriate technology and information systems.
• Analyze, evaluate, and apply relevant information from a variety of sources.
• Adapting communication skills to a variety of audiences including the public and the scientific communities
• Show respect for diverse opinions, values, belief systems, and contributions of others.
• Interact with others in teams and develop effective working relationships and the achievement of goals.
• Manage the use of time and other resources to complete projects.
• Take responsibility for one's own actions, decisions, and consequences.


 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 by computer.

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.

Format for Assignments
• Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecapolytechnic.ca



Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS