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The following are general recommended steps to support implementation of Trial Design datasets to represent the design of a trial. to move from . Implementers are encouraged to start with representation of more-familiar concepts, such as arms, and move to less-familiar concepts, such as elements and epochs. The In practice, the actual process of modeling a trial to implement Trial Design datasets may depart from these numbered steps . Some steps will overlap; there may be several iterations; and not all steps are relevant for all studies.with some steps overlapping and some steps not relevant to a specific study design.  When steps or aspects of steps are specific to Product Impact on Individual Health use cases only, this is denoted in the step.

1. Start with a clear understanding of your study design based on the protocol, especially the distinct paths of activities subjects will experience that spans the entire study. These paths are the arms for the study. Each path can have decision points where the paths diverge based on some criteria.
   1. Product Impact on Individual Health only: Start from the flow chart or schema diagram usually included in the
   trial
   1. protocol. This diagram will show how many arms the
   trial has
   1. study has, and the branch points or decision points where the
   arms diverge
   1. arms diverge.
2. Write down the decision rule for each branching point in the diagram. Does the assignment of a subject to an arm depend on a randomization? On whether the subject responded to a trial assessmentstudy assessment? On some other criterion?
3. If the trial study has multiple branching points, check whether all the branches that have been identified really lead to different arms. The arms will arms will relate to the major comparisons the trial study is designed to address. For some trialsstudies, there may be a group of somewhat different paths through the trial study that are all considered to belong to a single arm.
4. For each arm, identify the major time periods of evaluations of the tobacco product, a subject assigned to that arm will go through. These are the elements, or building blocks, of which the arm is composed.
5. Define the starting point of each element. Define the rule for how long the element should element should last. Determine whether the element is element is of fixed duration.
6. Re-examine the sequences of elements that make up the various arms and consider alternative element definitionselement definitions. Would it be better to “split” some elements into smaller pieces or “lump” some elements into larger pieces? Such decisions will depend on the aims of the trial and study and plans for analysis.
7. Compare the various arms and, where appropriate, define epochs.
   
   1. Product Impact on Individual Health only: In most
   clinical trials,
   1. studies especially blinded
   trials
   1. studies, the pattern of elements will be similar for all arms, and it will make sense to define
   trial
   1. epochs. Assign names to these epochs. During the conduct of a blinded
   trial
   1. study, it will not be known which arm a subject has been assigned to, or which
   treatment
   1. product exposure elements they are experiencing, but the
   epochs they
   1. epochs they are passing through will be known.
8. Product Impact on Individual Health only: Identify the visits planned for the trialstudy. Define the planned start timings for each visit, expressed relative to the ordered sequences of elements that make up the arms. Define the rules for when each visit should end.
9. Product Impact on Individual Health only: Identify the inclusion and exclusion criteria to be able to populate the Trial Inclusion/Exclusion Criteria (TI) dataset. If inclusion and exclusion criteria were amended so that subjects entered under different versions, populate TIVERS to represent the different versions.
10. Populate the TS dataset with summary information.

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