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Abstracting Groups and Cohorts
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Group/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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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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.
Trials can have multiple group/cohort records. Each record displays the following group information:
| Field | Definition |
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Label | Short name used to identify the group |
Description | Explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure). |
Assigned Interventions | Intervention assigned to a given group |
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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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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
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
- In the Delete column, select the check box for the appropriate record(s), and then click Delete.
- To delete all groups, click Select All, and then click Delete.
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Field | Instruction/Description |
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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. |
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Editing Groups
You can edit group records as necessary.
How to Edit Group Records
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Abstracting Sub-Groups
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A sub-group represents stratification criteria that can be used to assign patients to study arms and assess study outcomes. Sub-group information is required for Complete trials only, and optional for Abbreviated trials.
Trials can have multiple sub-group records. Each record displays the following information about the disease or conditions:
Sub-Groups Page Adding Subgroups
You can add one or more sub-groups to a trial according to the trial’s design details. How to Add Sub-groups
Editing SubgroupsYou can edit sub-group records as necessary. How to Edit Sub-group Records
Deleting SubgroupsWhen 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 Sub-Groups to add it back. How to Delete Sub-groups
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