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STANDARD OPERATING PROCEDURE SOP 004: Protocol and Investigational Brochure Content, Design, Amendments & Compliance Document ID: 004 Version: 1.0 Dated 30 September 2011 Author: Dr Tam Nguyen, Manager

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How to Fill Out Standard Operating Procedures:

1. Start by gathering all the necessary information and materials required for the specific process or task that the standard operating procedure (SOP) will outline.
2. Begin with a clear and concise title for the SOP, providing a brief description of the process or task it covers.
3. Write a comprehensive and detailed introduction that explains the purpose of the SOP and provides an overview of the process or task.
4. Break down the steps involved in the process or task, numbering them sequentially. Use clear and concise language to ensure that the instructions are easy to follow.
5. Include any necessary diagrams, charts, or visual aids to enhance clarity and understanding.
6. Provide any relevant background information or context that may be helpful for the person following the SOP.
7. Clearly define any specific terminology or acronyms used in the SOP to avoid confusion.
8. Include any safety precautions or necessary personal protective equipment (PPE) that should be followed during the process or task.
9. Add any required forms or checklists that need to be completed as part of the SOP.
10. Include any troubleshooting steps or contingency plans for potential issues that may arise during the process or task.
11. Conclude the SOP with any additional information, references, or resources that may be helpful.
12. Review and revise the SOP periodically to ensure it remains up-to-date and accurate.

Who Needs Standard Operating Procedures:

1. Organizations, including businesses, government agencies, and non-profit organizations, that want to ensure consistency and standardization in their processes and tasks.
2. Employees or team members who need clear instructions and guidelines to follow for specific processes or tasks they are responsible for.
3. Regulatory bodies or industry standards organizations that require the implementation of standard operating procedures as part of compliance measures.
4. Businesses or organizations that aim to improve efficiency, productivity, and quality by establishing standardized processes.
5. Individuals or teams working on complex projects or collaborations that involve multiple stakeholders and require clear communication and coordination.

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