CRP106 - Monitoring Clinical Research

Outline info
Semester
School
Last revision date 2017-05-29 00:41:32.635
Last review date 2017-07-17 00:16:27.897


Subject Title
Monitoring Clinical Research

Subject Description
This subject outlines the various milestones of clinical research in relation to monitoring of the clinical site. The subject defines the sponsor's and investigator's perspective and expectations in clinical research. Students gain the knowledge to ensure the study site processes and procedures are compliant and that data collected meets quality standards. Students learn the overall management and organization key elements required to monitor a study effectively.

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:

  1. Describe the key elements of monitoring/managing a clinical research site and ensuring protocol and regulatory adherence and compliance
  2. Understand the concept of risk-based monitoring, how to conduct a basic study risk assessment and mitigate risks identified
  3. Detect and prevent fraud and misconduct in clinical research
  4. Demonstrate an understanding of the steps followed to conduct monitoring activities and prepare the clinical research site for a regulatory inspection
  5. Create a monitoring plan for a given study

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 – Clinical Trial Regulations
CRP101 – Introduction to Drug Development/Clinical Trials

Topic Outline
Unit 1 – Review of Good Clinical Practices and Canadian Clinical Research Regulations
Unit 2 – Introduction to Clinical Research Monitoring
Unit 3 – Risk-Based Monitoring, Risk Assessment and Technology Use in Monitoring
Unit 4 – Monitoring Plans
Unit 5 – Site Selection Visits and Site Initiation Visits
Unit 6 – Interim Monitoring Visits and Closeout Visits
Unit 7 – Maintaining Site Compliance
Unit 8 – Maintaining Data Integrity and Acting on Study Misconduct
Unit 9 – Preparing for a Regulatory Inspection

Mode of Instruction
Lectures, audio­visual presentations, case studies, group work, in­class exercises. Students can expect to spend approx. 2­3 hours outside of class reading, doing assignments, etc.

Prescribed Texts

None

Reference Material
Class handouts and notes

The CRA's Guide to Monitoring Clinical Research, CenterWatch Karen E. Woodin, Ph.D., and John C. Schneider Softcover: 1930624379 4th edition

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
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 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


Grading  is based on the following marking scheme:
Monitoring Plan Assignment 20%
Risk Assessment Presentation 10%
Midterm Test 30%
Final Exam 40%

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

Approved by: Denis Gravelle