ADaM day 7
ADDV protocol deviation dataset identifies occurrences of sponsor-defined deviations, which is a list specified for every study.
For example, the description of deviation can be Positive Drug Screen, PK labs not drawn in the proper window.
A Sample ADDV Dataset
key variables：subjid, dvstdt, dvcatcd, dvdeter, dvdesc , dvdact, dvact1, dvtype, dvstype.
Key variable indications:
dvcatcd=”DV Category Code”
- Eligibility Criteria not fully met, or consent not obtained
- Failure in safety reporting or compliance with safety assessments
- Received wrong study treatment or incorrect dose
- Received an excluded concomitant treatment
- Efficacy assessment missing, or efficacy assessment visit not done
dvscatcd=”DV Subcatorgy Code”
dvstdt=”Start Date of Deviation”
dvdesc=”Description of Deviation”
dvact=”Corrective Action Taken”
dvact1=”Corrective Action Taken (1)”