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Designing Fit-for-Purpose SOPs: Structure

In our last post on SOPs, we discussed the value of boilerplate language, which promotes reading comprehension by use of familiar language. Similarly, SOPs that use a familiar structure will also improve reading comprehension and compliance.

The easiest structuring principle for readers to follow is chronological. We plan an activity, execute the activity, and document the activity. For many activities, we also need to consider change control – steps for changing the governing plan. Using that principle, here’s how we might structure various SOPs:

  • Protocol Development
    • Study Design and Feasibility
    • Protocol Development, Review, and Approval
    • Protocol Filing and Distribution
    • Protocol Amendments
  • Public Registries
    • Identification of Applicable Registries
    • Development, Review, and Finalization of Post
    • Receipt Filing and Notifications
    • Post Updates
  • Site Monitoring
    • Clinical Monitoring Plan Development, Review, and Approval
    • Site Monitor Selection and Training
    • Monitoring Visit Conduct
    • Monitoring Visit Report Development, Finalization, and Follow-Up
    • Monitoring Plan Changes
  • Statistical Analysis
    • SAP Development, Review, and Approval
    • Development and QC of Statistical Deliverables
    • Delivery and Archival of Statistical Deliverables
    • SAP Amendments

When readers can’t follow a chronological thread, they’re forced to skip around in the SOP to piece the steps together in the right order.

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