CRP110 - Medical Writing and Clinical Research Project

Outline info
Semester
School
Last revision date 2017-11-21 10:47:01.954
Last review date 2017-11-21 10:47:09.266


Subject Title
Medical Writing and Clinical Research Project

Subject Description
In this course students develop a clinical trial protocol including a plan for training, monitoring and data management. Concepts including grant writing, literature reviews, communication skills and data interpretation will be covered. Students develop clinical trial documents including informed consent documents and case report forms for each study visit. Teams of students prepare presentations for lay and scientific audiences.

Credit Status
One credit towards CRQ program

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

• Critically appraise the medical literature to develop a clinical trial protocol
• Write a scientific abstract and lay summary
• Create an Informed Consent Form for the selected study
• Research available information related to the specific population(s) and therapeutic area(s) chosen
• Apply the appropriate ethical considerations to a clinical study design
• Learn about dissemination techniques including poster presentations and short oral presentations
• Create training and monitoring plans up to the ICH standards for Good Clinical Practice
• Apply regulatory science to ensure clinical trial is aligned with drug development requirements
• Application of ethical principles and knowledge gained from semester 1 and co-op to real-world examples.

Essential Employability Skills
Communicate clearly, concisely and correctly in the written, spoken and visual form that fulfils the purpose and meets the needs of the audience.

Respond to written, spoken, or visual messages in a manner that ensures effective communication.

Execute mathematical operations accurately.

Apply a systematic approach to solve problems.

Use a variety of thinking skills to anticipate and solve problems.

Locate, select, organize, and document information using appropriate technology and information systems.

Analyze, evaluate, and apply relevant information from a variety of sources.

Show respect for diverse opinions, values, belief systems, and contributions of others.

Interact with others in groups or teams in ways that contribute to 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.

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, PQA711, TWC713
Co-requisites: CRP106

Topic Outline
• Reading and interpreting the medical literature
• Ethical and scientific concepts behind the development of informed consent documents
• Introduction to medical writing - Tailoring your message
• Grant writing
• Disseminating research findings (abstracts, oral presentations, posters)
• Review of CRF requirements
• Review of Protocol requirements
• Review of Monitoring requirements
• Review of Training requirements

Mode of Instruction
Lectures, audio-visual presentations, group work and in-class exercises. Students can expect to spend approx. 2-3 hours outside of class reading, doing assignments, etc. Students are responsible for developing and enforcing group workload contracts.

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

  Type of Mark: Percentage of Final Grade:
Trial design outline Group 5
Protocol Group 15
Lay summary Group 5
Scientific summary Group 5
Monitoring Plan Group 10
Training Plan Group 10
Case Report Form Individual 10
Informed Consent Form Individual 10
Class Presentation Individual 15
Peer Review and Participation Individual 15
 
Modes of Evaluation Term Work and Final Exam
• There is no final exam for this course

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.
• Members not contributing to group assignments according to the group workload contract will receive a mark of 0

Absenteeism and Exams
• Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
• There are no deferred options for missed presentations.  The value of missed presentations will be 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