Tool: Trial
ACTION PLAN

The first version of the trial action plan (TAP) was created during the DRIVER+ project to serve the role of the main trial planning and preparing document. It covers all areas related to the trial organisation and will be used to record the efforts, circulate decisions and assess the progress. Its secondary role is to function as an internal progress reporting document. The TAP fundamental role is to facilitate collaborative planning and to support combined execution. It should be considered as a support tool facilitating the trial management. It is designed to be used as a living document (document being continually edited and updated by many authorised people). It means that the document is continuously up to date in line with new decisions and actions being realised in the course of the preparation work of the trial committee and other involved stakeholders. This approach allows all important arrangements, conclusions and effects of work to be collected, thus constituting the TAP as a repository (also a coordination and information sharing tool) available to all stakeholders.

The document is provided in a form of a self-descriptive template with completion guidelines that also links the user with DRIVER+ methodological documents. Moreover, it supports the application of DRIVER+ methodology. It accommodates and cites all the decisions of trial committee concerning the methodological aspects of the trial preparation. This includes among other things: description of gaps selected for the trial, general and specific research questions the trial will respond to, the solution selection process and its results, initially identified key performance indicators for evaluation of selected solutions, data collection, evaluation approaches and metrics and general scenario formulation.

The TAP includes several filling aids, facilitating the process of its completion:

• The completion guide (precisely explaining the logical systematisation of progressing with the trial preparation and execution and suggests the correct order of advancements);
• Other instructions, checklists and revision guide.

It is supported by a training module created as a supplement to TGM module.

• Collaborative, systematised workspace that can host decisions and actions - document oriented on task: preparing and executing the trial.
• Completes all the information gathered throughout the preparation and execution phase by all trial stakeholders in a concise form. Serves as a main planning document. Output: aggregation of data in one collaborative worksheet, linked with all trial related documents, that is easy to use.