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AnchorabstractcohortabstractcohortGroup/cohort information pertains to Complete non-interventional trials only. In non-interventional studies, cohorts are groups of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who are examined or traced over a given time period.

When adding groups to a trial, you assign to them the interventions currently abstracted for the trial.

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titleCheck out the trial before you begin abstraction

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For instructions on abstracting interventions, refer to Abstracting Interventions.

The following rules apply to each trial:

  • There must be at least one group/cohort that implies that the entire study subject population receives the same intervention.

  • The number of groups/cohorts added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Non-Interventional Trial Design Details.

  • Every group/cohort must have at least one assigned intervention.
  • Every intervention must be assigned to at least one group/cohort.
  • A trial must have only one group with the same combination of description and associated intervention.

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Anchor
groups
groups
 Groups page annotated to indicate features
Group Records

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Adding Groups

You can add one or more groups to a trial according to the number specified in the trial’s design details. See Abstracting Non-Interventional Trial Design Details .

How to Add Groups

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Field

Instruction/Description

Label*

Enter the descriptive name of the group.

Description*

Enter a brief description of the group.

Assignment

Select the check box(s) in the column for the intervention(s) assigned to the current group.

For instructions, refer to the following pages:

Page Tree
rootAbstracting Groups and Cohorts

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Editing Groups

You can edit group records as necessary.

How to Edit Group Records

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Deleting Groups

When you delete groups from a trial, you delete them from the system, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Groups to add it back.

How to Delete Groups

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