Writing Job Description & Standard Operating Procedures in International Organizations

Course Objectives
    •    Define a Standard Operating Procedure (SOP)
    •    Explain the regulatory and human subject protection rationale for SOPs.
    •    Conduct an assessment (gap analysis) of the organization for SOPs.
    •    Identify the components, standards and requirements for SOPs.
    •    Practice writing an SOP.
    •    Prepare for an audit of the organization's SOPs.
    •    Describe Good SOP Management Practices.

Course Topic Overview:
    •    Good business practices and regulatory requirements for SOPs
    •    Identifying the need for SOPs and associated documents
    •    Preparing to write and SOP
    •    Individual Components of SOPs
    •    Implementation and management of SOPs
Key Learning Outcomes:
    •    Have a clear understanding of the requirements for SOPs in clinical research
    •    Explored options for template setting and layouts for SOPs
    •    Have written an SOP based on the principles covered
    •    Be able to identify the need for SOP within your environment
    •    Personnel who are required to write/review
    •    SOPs
    •    Personnel with a responsibility for quality
    •    management
    •    Personnel with an interest in understanding
    •    more about SOP

    •    Proven strategies to ensure usable SOPs
    •    Techniques that make SOP writing easy
    •    Methods to help writers anticipate and prevent problems
    •    Useful techniques to write user-friendly SOPs
    •    Valuable tips for writing the various sections of SOPs


                                                                COURSE AGENDA

                                                                DAY ONE
Systems and Controls
    •    Introductions
    •    Document integrity and control
    •    Regulatory requirements and good business practices
    •    Determining which process documents to put in place
    •    Documents for overall systems and specific activities
    •    Process documents and their relationship to other documents
    •    Preventing overlaps, contradictions, and disconnects 

Writing Effective Policies, Procedures, Instructions, and Methods
    •    Components of Standard Operating Procedures, instructions, and methods
    •    Controlling sequence of actions
    •    Choosing the correct voice
    •    Using the present tense
    •    Writing about conditions
    •    Avoiding ambiguity and redundancy
    •    Using parallel structure
    •    Being consistent from document to document 

Procedure Writing Workshop
    •    Writing a procedure
    •    Assessing the process
    •    Refining it on paper
                                                                DAY TWO

Manuals and Plans
    •    Know your audience
    •    Components of quality manuals 
    •    Components of Chemical Hygiene and other plans 
    •    Identifying responsibilities 
    •    Explaining systems and activities 
    •    Controlling voice 
    •    Writing section by section
    •    Controlling sentences 

Refining Style
    •    Precision - making every word count
    •    Identifying false language rules
    •    Participants - grammar concerns
    •    Language bugbears and how to avoid them
    •    Punctuating for clarity 
    •    Establishing a non-binding style guide 

Reviewing and Revising
    •    Finalizing the document for review
    •    Peer review
    •    Formal review - author and reviewer roles
    •    Making sure the components are in place
    •    Refining the purpose and scope
    •    Assessing and improving the flow 
    •    Making comments on review documents 

Remaining Compliant
    •    Periodic review cycles
    •    Building document histories
    •    Revisions and impact on other documents
    •    Setting reasonable time frames from planning to active document
    •    Training on procedural documents 
    •    Remaining compliant

                                                                                DAY THREE
    •    Work break down structure
    •    Logical network diagram
    •    Bar charts & activity calendar
    •    Job analysis formats & 4 types of methods
    •    Writing Job description & specification
    •    Website learning