Create Cohorts

Cohorts categorize a group of subjects expected to progress through the trial together. Cohorts are established within each Epoch and subjects are activated within each Epoch/Cohort combination as they move through the study. An Epoch/Cohort combination also defines the type of subject number (Screening, Lead In, Randomization) that a subject will receive during that stage of their participation. The following basic settings are established when creating cohorts:

• Name: Name of the cohort. i.e. Cohort 1, Cohort 2, etc.

• Subject Action: Type of subject number that will be assigned to a subject upon activation within this cohort (Screening, Lead In, Randomization)

• Description: Optional details about the cohort.

And the following settings dictate how volunteers/subjects are selected for cohorts and which volunteers/subjects may be activated within a cohort:

Subject / Volunteer Source

• Subject Initiation: If checked, a new subject record is initiated upon activation of a volunteer within this cohort.

• Volunteer Database: If checked, a volunteer may be selected directly from the volunteer database.

• Appointments: If checked, a volunteer may be selected from existing appointments.

• Screening Cohorts: If checked, a subject may be selected from existing screening style cohorts.

• Lead In Cohorts: If checked, a subject may be selected from existing lead in style cohorts.

• Randomization Cohorts: If checked, a subject may be selected from existing randomization style cohorts.

Study / Volunteer Participation Allowance

• Study Cohorts: If unchecked, a subject must not be marked as active within other cohorts in the same study in order to be activated in this cohort.

• Other Studies: If unchecked, a subject must not be marked as active in other cohorts in other studies in order to be activated in this cohort.

Subject Eligibility Allowance

• Eligible: If checked, subjects with an ‘Eligible’ eligibility status may be activated within this cohort.

• Pending: If checked, subjects with a ‘Pending’ eligibility status may be activated within this cohort.

• Ineligible: If checked, subjects with an ‘Ineligible’ eligibility status may be activated within this cohort.

• Unspecified: If checked, subjects with an ‘Unspecified’ eligibility status may be activated within this cohort.

Subject Status Allowance

• Active: If checked, subjects with an ‘Active’ subject status may be activated within this cohort.

• Complete: If checked, subjects with a ‘Complete’ subject status may be activated within this cohort.

• Terminated: If checked, subjects with a ‘Terminated’ subject status may be activated within this cohort.

• Withdrawn: If checked, subjects with a ‘Withdrawn’ subject status may be activated within this cohort.

Subject Data Requirements

• Informed Consent: If checked, only subjects for whom ICF signing has been documented may be activated within this cohort.

• Over Volunteering Check: If checked, only subjects for whom an over volunteering check (i.e. VCT) has been documented may be activated within this cohort.

Screening Cohorts

Subjects receive a screening number at the time of their activation within a screening style cohort. Typical screening cohort settings are as follows:

Lead-In Cohorts

Subjects receive a lead in number at the time of their activation within a lead in style cohort. Note that a lead in number is not required as part of a subject’s progression through a trial. However if a lead in number is leveraged, typical lead in cohort settings are as follows:

Randomization Cohorts

Subjects receive a randomization (or ‘enrollment’) number at the time of their activation within a randomization style cohort. Typical randomization cohort settings are as follows:

Follow Up Cohorts

Subjects typically retain their randomization (or ‘enrollment’) number at the time of their activation within all cohorts following their first randomization style cohort activation. Subsequent cohorts to the initial randomization cohort typically include the following settings: