CRP109 - Clinical Research Data Management

Outline info
Semester
School
Last revision date 2017-05-29 00:41:35.346
Last review date 2017-07-17 00:16:35.585


Subject Title
Clinical Research Data Management

Subject Description
Clinical research involves the collection of complete and quality data. Students learn the elements of Good Laboratory practice, sample collection, storage and transport. This course includes the use of Clinical Data Management Systems (REDCap, Medidata) to review the establishment and validity of clinical research data. Students will apply statistical analysis to clinical sample datasets. 

Credit Status
One credit towards CRQ program.

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

• Practice designing and using a case report form for capture of clinical research data
• Describe the role of data managers in study start up, conduct and study maintenance
• Review laboratory testing and quality control to determine the validity of laboratory data
• Evaluate false positives and negatives in laboratory results
• Prepare a statistical analysis plan
• Use mean, median, SD and confidence limits to analyze and summarize clinical research data

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 data management
2. Standards for data management, reporting and quality 
3. Creating, completing and validating case report forms 
4. Electronic data capture systems 
5. Data privacy
6. Sample collection, storage and biosafety
7. Transportation of dangerous goods
8. Lab panels and reference ranges
9. Introduction to descriptive biostatistics
10.  Introduction to comparative biostatics
11.  Error, power and sample size
12.  Writing a statistical analysis plan

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
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

Building a CRF: 30%
Biostatistics assignment: 20%
Statistical analysis plan: 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