Create Cohort Assignments
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Create Cohort Assignments
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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
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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
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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
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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
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Role: Clinical Research Coordinator
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