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Document ICF Signing

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Document ICF Signing

https://vimeo.com/438010212/2c52238415

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

INSERT VIDEO HEREhttps://vimeo.com/438010170/ac168513de

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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https://vimeo.com/438010200/8f3d8f1553

https://vimeo.com/438010192/2f0d1621ae

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.

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