Source: Schedule of Assessments inspired by a COVANCE virtual trials presentation, Playbook team analysis
Deploying remote monitoring can reduce patient burden and increase enrollment speed and inclusivity during a clinical trial
The Playbook / Customize by context of use / Clinical research
In this example, shifting some of the assessments to remote collection can reduce patient burden:
FROM 10 site visits
TO 4 site visits and 6 at-home visits
Sample Study Schedule of Assessment | ||||||||||
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Week | -6 | 0 | 1 | 2 | 3 | 4 | 6 | 8 | 12 | 16 |
Informed consent, Demography, Habits, Medical History | X | | | | | | | | | |
Inclusion/Exclusion Criteria | X | X | | | | | | | | |
Full Physical, Height & Weight | X | | | | | | | | | |
Prior Medical History | X | X | | | | | | | | |
Assessment Potential of Adverse Events (AEs) | X | X | X | X | X | X | X | X | X | X |
Laboratory assessments | X | X | X | X | | X | | X | X | X |
Drug screen | X | | | | | | | | | |
Urinalysis | X | X | | | | X | | | X | X |
C-reactive protein (CRP) | X | X | X | X | | X | | X | X | X |
12 Lead ECG | X | X | X | X | | X | | X | X | X |
Vital signs | X | X | X | X | | X | | X | X | X |
Randomization | | X | | | | | | | | |
Study medication dispensation | | X | | | | | | | | |
CGM & FBG | | X | X | X | | X | | X | X | |
Sleep assessment | | X | X | X | X | X | X | X | X | X |
Health Assessment Questionnaire Disability Index (HAQ-DI) | | X | X | X | | X | | X | X | X |
Questionnaires PROs | | X | | X | | X | | X | X | |
On-site
Virtual Visit (video or audio)
connected sensor product
Mobile Phlebotomist
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