CRP104 - Clinical Study Administration

Outline info
Semester
School
Last revision date 2017-05-29 00:41:34.392
Last review date 2017-07-17 00:16:27.749


Subject Title
Clinical Study Administration

Subject Description
This course provides an overview of the management and conduct of clinical trials and the staff involved in conducting clinical trial research. Topics include essential documents in the clinical trial, the need for SOPs and qualified staff, and process for adequate oversight of the clinical trial.

Credit Status
One credit towards CRQ program.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

• Plan for the conduct of a given study.
• Identify and interpret vital documentation involved in clinical research
• Discuss the design and content requirements for Investigator's Brochure, Clinical Study Protocols, Informed Consent form and Case Report forms
• Discuss the importance of Standard Operating Procedures (SOPs) and the documentation of training and qualification of personnel conducting a clinical study
• Discuss the importance and impact of subject recruitment strategies
• Relate fundamentals of Project Management to elements of Clinical Research
• Define the Project Management team members, roles and responsibilities using clinical trial examples.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

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@senecacollege.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 Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
CRP100 / CRP101 / CRP104 / CRP108 / CRP113 / TWC713

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
 

Reference Material
None

Required Supplies
None

Promotion Policy

Grading Policy
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.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation


Assignment #1; group protocol: 30%
Assignment #2; informed consent form: 20%
Assignment #3 oral presentation: 10%
Final exam: 40%

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.senecacollege.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

Approved by: Denis Gravelle