sop writing

RAPM 58619- Principles of Good Practices GxP (Fall 2023 Term)Assignment #2 Outline
Due date: 11:59 PM EST on Tuesday, November 7, 2023
Weight: 15%
The penalty for late submission of written assignments is a loss of 10% per day
for up to five business days (excluding weekends and statutory holidays), after
which, a grade of zero is assigned. Business days include any day that the
college is open for business, whether the student has scheduled classes that day
or not.
Assignment Instructions
Students will review the scenario outlined on page two of this assignment outline.
Students will develop a Standard Operating Procedure (SOP) for obtaining
informed consent from patients for enrolment in a clinical research study.
The SOP should be a maximum of six (6) pages (not including title page and
references, as applicable). The formatting should be 12-point font, Times New
Roman, double-spaced and should follow proper SOP formatting. The SOP must
include the following sections (however, students may wish to include additional
sections, as needed):
1. Header
2. Purpose/Objective
3. Scope
4. Roles and Responsibilities
5. References
6. Acronyms
7. Definitions
8. Written Procedure for Informed Consent
9. Associated Forms
10. Change Summary/Revision History
Students should also make reference to concepts related to Good
Documentation Practices (Module 2) and Good Clinical Practice (Module 3) in
their SOP, as applicable.
Please note that students will be assessed based on the following:
 Spelling and grammar
 SOP design and formatting
 Completeness and clarity of SOP sections and written procedure
 Integration of course content
RAPM 58619- Principles of Good Practices GxP (Fall 2023 Term)
Students will not be graded based on the accuracy of their content in real clinical
practice. Students may wish to outline any key assumptions made for their
assignment should they feel that any information is missing from the scenario
below that is critical to the development of the SOP.
Notes:
It is extremely important for students to stay within the six-page limit. Any
additional information provided beyond six pages will not be graded.
While references are not mandatory for this assignment, any references used as
part of your assignment must be referenced in your SOP using proper APA
format including use of in-text citations. Marks will be deducted for improper APA
referencing and in-text citations.
Scenario: You are the Research Coordinator for a new clinical research study
being conducted at a clinic at Canada General Hospital. The study is evaluating
the safety and efficacy of a new medication to be used to treat patients with heart
disease. Patients that present to the clinic for routine check-ups will be assessed
against inclusion and exclusion criteria for the study and patients meeting the
inclusion criteria will be recruited to participate in the study. You and your team
will be responsible for discussing the study with eligible patients and obtaining
their consent to enrol in the study. Consent from patients will be documented in
FRM-001 Patient Informed Consent Form. You are tasked with developing a
clear and detailed SOP outlining the procedure to be followed for obtaining
informed patient consent.
For the purposes of this assignment, you can assume that the patient population
is literate, has full proficiency in English and does not require consent from a
parent/guardian or legally acceptable representative.