Setting up a Study to include cohorts allows users to filter and display participants by cohort. A cohort is a group of participants who share particular demographic or study characteristics (e.g., all participants of one gender, or all with a particular HIV status).

For information on using cohorts once they have been set up, please see the User Guide for Cohorts.

Manage Cohorts

Administrators can access the "Manage Cohorts" page via these routes:

  • From within a study, click the Manage tab, and then click Manage Cohorts.
  • From any datagrid, select Participant Groups > Manage Cohorts.
You can see an example Manage Cohorts page in the interactive example.

Assignment Mode: Simple or Advanced

  • Simple: Participants are assigned to a single cohort throughout the study. For example, gender or demographic cohorts set up to track the impact of a given treatment on different categories of individual.
  • Advanced: Participants may change cohorts mid-study. For example, if your cohorts are based on disease progression or treatment regimen, participants would potentially move from cohort to cohort based on test results during the term of the study. Note that advanced cohort management requires automatic assignment via a study dataset that can include multiple participant/visit pairs (i.e. not a demographic dataset).
Switching between assignment modes requires updating cohort assignments for all participants.

Assignment Type: Automatic or Manual

Participants can be assigned to cohorts manually, or automatically based on a field you specify in a dataset. If you are automatically assigning cohorts, you will also see a section here for specifying the dataset and field. See Assign Participants to Cohorts for further information.

Defined Cohorts

The Defined Cohorts section lists all cohorts currently defined for the study. You can insert new cohorts, delete unused ones, and export information about current cohorts in various formats.

Each defined cohort has an Edit link you may use to specify whether the members of that cohort are considered enrolled in the study, the expected or target subject count, and a short text description of the cohort.

If desired, you can also add to the default fields that define a cohort by clicking Edit Cohort Definition and specifying additional fields. The new fields you define can then be specified using the per-cohort Edit links as above.

Participant-Cohort Assignments

The bottom of the "Manage Cohorts" page shows a list of the participants within the current study and the cohort associated with each participant.

Assign Participants to Cohorts

Automatic Cohort Assignment

The Automatic option for mapping participants to cohorts allows you to use the value of a dataset field to determine cohort membership. The field used must be of type string.

  • Select the name of the mapping dataset ("Demographics" in this example) from the Participant/Cohort Dataset drop-down menu.
  • Select the Cohort Field Name you wish to use ("Treatment Group" in this example).
  • Click Update Assignments.

To record time-varying cohort assignments, your assignment dataset must be able to contain multiple participant/visit pairs for each participant. Each pair will record the entrance of a participant into a new cohort. It is not necessary to have a data entry for every participant/visit combination. Demographic data, which is collected once per participant in a study, cannot record these time-varying assignments.

Manual Cohort Assignment

If you wish to manually associate participants with cohorts, and do not need to use time-varying cohorts, select "Manual" from the radio buttons. For each participant, choose a cohort using the dropdown menu which lists available cohorts. Scroll down to click Save when you have finished assigning participants to cohorts.

Use Cohorts

For information on using cohorts and filtering datasets based on cohorts, see the User Guide for Cohorts.

Discussion

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