RAPM 58619-  Principles of Good Practices GxP

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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

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.