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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:
Study Design and Feasibility
Protocol Development, Review, and Approval
Protocol Filing and Distribution
Identification of Applicable Registries
Development, Review, and Finalization of Post
Receipt Filing and Notifications
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
SAP Development, Review, and Approval
Development and QC of Statistical Deliverables
Delivery and Archival of Statistical Deliverables
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.