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Table 3 Summary table of key learnings

From: The data management of a phase III efficacy trial of an 11-valent pneumococcal conjugate vaccine and related satellite studies conducted in the Philippines

Do’s

Don’ts

To function effectively and efficiently, careful trial preparation and conscious efforts to follow SOPs for data collection and management should be done

Sometimes missing coordination of responsibilities and operational leadership in such distributed project

The international collaboration of data management personnel from the Philippines, Australia, and Finland managed to work effectively through different means of communication

The vaccine did not go further in licensure path – manufacturer withdraw and thus rest of consortium took response of management – reorganizational difficulties

Having committed and trained data management personnel is one of the significant factors in the conduct and success of a large clinical trial

Allocation of resources for post processing of data – timetable was stretched