ADaM.ADDV

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”

dvcat=”DV Category”

  1. Eligibility Criteria not fully met, or consent not obtained
  2. Failure in safety reporting or compliance with safety assessments
  3. Received wrong study treatment or incorrect dose
  4. Received an excluded concomitant treatment        
  5. Efficacy assessment missing, or efficacy assessment visit not done 
  6. Other           

dvscat=”DV Subcategory”

dvscatcd=”DV Subcatorgy Code”

dvstdt=”Start Date of Deviation”

dvdeter=”DV Determination”

dvtype=”DV Type”

dvstype=”DV Subtype”

dvcatn=”DV Category(N)”

dvdesc=”Description of Deviation”

dvact=”Corrective Action Taken”

dvact1=”Corrective Action Taken (1)”

 

Sample output:

 

Happy Studying!

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