Document ICF Signing
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Document ICF Signing
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| url | https://vimeo.com/438010212/2c52238415 |
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Role: Clinical Research Coordinator
Documentation of ICF signing should be the first data collection activity completed for each subject and is required before subsequent data collection can occur. Note that a subject’s screening cohort assignment must be fully activated before ICF signing becomes available for documentation.
Over Volunteering Check
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| url | https://vimeo.com/438010170/ac168513de |
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Role: Volunteer Recruiter
An over volunteering check helps to ensure that a volunteer is not currently participating (or has not too recently participated) in another clinical trial. This process can either be documented manually, or in a more automated fashion by way of ClinSpark integration with Verified Clinical Trials.
Safety Assessments
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| url | https://vimeo.com/438010200/8f3d8f1553 |
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| url | https://vimeo.com/438010192/2f0d1621ae |
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Role: PI
Safety assessments occur regularly throughout a trial and facilitate investigator oversight and interpretation of collected data in a common location for ease of access. Typical PI safety assessments include the assignment of significance and/or normality to out of range vitals or ECG measurements. Laboratory results may also be reviewed via the assessment workflow, although results are typically reviewed by way of the Study > Lab Data Module.
Eligibility Assessment
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| url | https://vimeo.com/438010180/b52ff13452 |
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Role: PI
After all screening data has been collected and all investigator assessments have been completed and lab results reviewed, eligibility determination can be completed for each subject. This includes the review of automated eligibility checks which are applicable at screening; followed by an assignment of eligibility status. Eligibility status after screening will dictate which volunteers are invited back for a lead-in visit.