Summary: This NCCIH “Guidelines for Developing a Manual of Operations and Procedures (MOP)” is useful for site onboarding in pragmatic clinical trials because it provides a structured blueprint for turning the protocol into an operational guide that standardizes how procedures are executed and documented across sites, thereby improving consistency in implementation and data collection. It specifies the core elements a site needs to be trained on, roles and responsibilities, staff rosters and points of contact, training and communications plans, study flow diagrams tailored for new staff, screening/eligibility processes, consent procedures, safety reporting, protocol deviation tracking, data collection/form completion rules, quality control, and closeout, supported by practical sample tools (e.g., screening log, schedule of events, deviation log, and MOP modification log) that reduce ambiguity and lower day-to-day cognitive load for site teams during initiation and early implementation. 

Summary: This Staff Study Guide template is useful for pragmatic trial site onboarding because it converts the protocol and operational requirements into a standardized, staff-facing implementation manual that specifies what “ready to launch” entails, how study tasks integrate into routine care (including triggers, documentation points, and what to do when the usual workflow deviates), and how responsibilities, training expectations, and communication pathways are assigned across the site and central team. It also operationalizes high-risk processes, such as patient notification/opt-out consent and safety reporting, using stepwise instructions and clear escalation rules, and it supports consistent execution through practical appendices (e.g., action-vs-awareness guidance, quick checklists, recruitment tracking, consent flow charts, data entry/query troubleshooting, and a trial timeline), thereby reducing ambiguity and cognitive load for busy clinical teams.