Assignment: 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.
Table 1.1 Example 'lines of QA SOPs
- Responsibilities and functions of the quality assurance unit
- Project quality assurance
- Inspection by regulatory authorities or sponsors
- Procedure for subcontracting work
- Audit of project reports
- Audit of clinical protocols
- Audit of laboratory protocols
- Audit and integrity of computer systems and software
- Inspection of clinical archives
- Inspection of laboratory archives
- Training of quality assurance staff
- Quality assurance of clinical biochemistry results
- Preparation and use of standard operating procedures
- Audit, storage, and issue of standard operating procedures
- Quality control of reports
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. Need Assignment Help?
(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?