using an SOP format, and supporting your work with appropriate references (in addition to the Ogg textbook), create a SOP. The NIH link above provides a template for reference when creating your SOP.
In the textbook, on page 17 Ogg states that, “QA itself requires a set of SOPs that cover all aspects of the units’ operations and will consequently form the bedrock of your system.” Choose one of the examples from Table 1.1 on page 17 of the Ogg textbook, Example Titles of QA SOPs.
In a 2-3 page document, using an SOP format, and supporting your work with appropriate references (in addition to the Ogg textbook), create a SOP. The NIH link above provides a template for reference when creating your SOP. Your SOP document must include and explain (at minimum) the following three sections related to the SOP chosen:
(1) Purpose: Describe the importance of the SOP to Quality Assurance (QA)? How used in the conduct of clinical trials? Provide specific examples of its use.
(2) Scope: What needs to be included in the content of the SOP (processes, steps, etc)? What are the key quality factors this SOP will address?
(3) Responsibility: Who are the stakeholders (study roles) for this specific SOP? (Who is responsible for implementing the SOP? Who is affected by the SOP?) What are the responsibilities of each identified stakeholders in the SOP?
Assignment is due on Saturday by 11:59 p.m. (AZ time).
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Rubric: SOP |
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Criteria |
Ratings |
Pts |
|
This
criterion is linked to a Learning OutcomeFormat, Spelling, Grammar |
10 ptsProficientProfessionally written; SOP format;
clear and succinct; no spelling or grammar errors; covers topic accurately. 6 ptsCompetentProfessionally written; SOP format;
clearly organized, less than 3 spelling or grammar errors; covers topic
accurately. 0 ptsNoviceDoes not do, poorly done and does
not address assignment. |
10 pts |
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This
criterion is linked to a Learning OutcomePurpose |
15 ptsProficientProvides a clear description of why
the SOP is important in Quality Assurance. Explain how SOP is used in the
conduct and assurance of quality in clinical trials. Provide 2-3 specific
examples of how/where it is used within the context of conducting clinical
trials. 7.5 ptsCompetentProvides a clear description of why
the SOP is important in Quality Assurance. Explain how SOP is used in the
conduct and assurance of quality in clinical trials. Provide at least 1
specific example of how/where it is used within the context of conducting
clinical trials. 0 ptsNoviceFails to do; poorly written; does
not describe the purpose. |
15 pts |
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This
criterion is linked to a Learning OutcomeScope |
15 ptsProficientScope defines the steps/processes
needed to implement the SOP adequately. Describes the functions of the SOP
and how will it be implemented. Define the key points/factors related to
quality. Identifies all staff impacted by the SOP. 7.5 ptsCompetentScope defines the steps/processes
needed to implement the SOP adequately. Describes the functions of the SOP
and how will it be implemented. Defines a minimum of two the key
points/factors related to quality. Identifies 2 - 3 staff impacted by the SOP 0 ptsNoviceDoes not do; poorly written and
does not address the requirements of the assignment. |
15 pts |
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This
criterion is linked to a Learning OutcomeResponsibility |
10 ptsProficientIdentifies the department and
specific role within the depart responsible for creating and implementing the
SOP. If appropriate, identifies roles within the organization responsible for
disseminating the SOP and training staff. 5 ptsCompetentIdentifies the department and
specific role within the depart responsible for creating and implementing the
SOP. 0 ptsNoviceDoes not do or poorly written and
does not meet the requirements of the assignment. |
10 pts |
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Total Points: 50
