Treatment Cohort Management

Create Cohort Assignments

Role: Clinical Research Coordinator

Treatment (or ‘Randomization’) cohort assignments mark the progression of a subject past lead-in and into the dosing stage of the study (typically ‘Day 1’). At this stage, subjects receive a unique randomization number (the third and final number of a possible three-part subject number). These cohort assignments can be created as soon as the treatment activity plan is complete and approved, randomization numbers are known, and dosing times are established. These assignments are almost always created without volunteers associated since volunteers to be dosed are not known until the evening before or morning of dosing. Note that alternate/backup cohort assignments should also be created in the event that a ‘planned’ subject becomes ineligible prior to dosing.

Activate Plans

Role: Clinical Research Coordinator

Treatment activity plans can be activated as soon as the treatment activity plan has been completed and approved, randomization numbers are known, and dosing times are established. Although volunteers have not been assigned yet, activation of plans allows for printing of labels that do not require volunteer-identifying information (such as date of birth, initials, and gender). PK labels typically meet this criteria.

Randomize Subjects

Role: Clinical Research Coordinator

Once it is known which subjects will likely dose (pending pre-dose activities) volunteers can be associated with the treatment/randomization cohort assignments. This can either be accomplished by manually associating a volunteer with each assignment or by way of ClinSpark’s built-in randomization feature.

Activate Volunteers

Role: Clinical Research Coordinator

Once there is a level of certainty that the volunteers assigned to each treatment cohort assignment will be dosed, the volunteers should be activated. This typically occurs early morning on the day of dosing to allow time for pre-dose safety label printing and study product / drug label printing.

Using Alternate Subjects

Role: Clinical Research Coordinator

If a subject who was anticipated to dose becomes ineligible prior to dosing and after full activation of the associated treatment cohort assignment, an alternate subject can assume the place of the now-ineligible subject by way of ClinSpark’s subject swap feature. This feature allows already-printed volunteer-independent labels intended for the now-ineligible subject to be used for the replacement subject instead. Alternatively, if a subject becomes ineligible prior to dosing and volunteer activation for the corresponding cohort assignment has not yet occurred, then the associated volunteer can simply be updated by way of editing the cohort assignment. In either case, already-printed labels containing volunteer-identifying information will need to be reprinted.