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. 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.
Trials can have multiple group/cohort records. Each record displays the following group information:
| Field | Definition |
|---|---|
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 |
Group Records
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
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
On the Scientific Data menu, click Groups/Cohorts. The Groups page appears, with or without any group records displayed.
- Click Add. The Add Group page appears. The interventions that have been abstracted previously are displayed on the right side of the page.
In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
You can expand text fields and table cells to reveal all of their content
To increase the size of a text field or table cell, click and drag the lower right corner handle.
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.
- Repeat the steps above until all groups have been assigned an intervention and all interventions have been assigned to at least one group.
- Click Save.
Editing Groups
You can edit group records as necessary.
How to Edit Group Records
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
- In the Edit column for a given record, click the Edit icon.
The Edit Group page appears.
- Make changes as necessary to the Label, Description, or Intervention Assignment according to instructions in Adding Groups.
You can expand text fields and table cells to reveal all of their content
To increase the size of a text field or table cell, click and drag the lower right corner handle.
- Click Save.
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. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
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.
