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@PiotrZakrzewski
Last active May 4, 2016 08:48
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#Patient Registration

  • presence of required fields. Taken from Study parameters.
  • Study exists in OC,
  • Site exist in the study
  • uniqueness of Study Subject ID (SSID) within file
  • width of SSID max 30 characters
  • gender is either "m" or "f"
  • uniqueness of PersonID in the Study
  • date format of Date of Enrollment
  • Width of Secondary ID max 30 characters
  • Date of birth format. Has to be in the past.

#Event Registration

  • presence of required fields. Taken from Study parameters.
  • Study exists in OC,
  • Site exist in the study
  • uniqueness of Study Subject ID (SSID) within file
  • width of SSID max 30 characters
  • Location width max 4000 characters
  • date format of Start Date
  • correct start time, between 0:00 and 23:59
  • correct end time, between 0:00 and 23:59. End time after start time
  • date format of End Date. End Date after Start Date
  • repeat number is an integer bigger than 0
  • repeat numbers form consecutive numbering from 1 to n where n is the highest value

#Data

  • presence of required fields. Taken from Study parameters.
  • Study exists in OC,
  • Site exist in the study
  • uniqueness of Study Subject ID (SSID) within file
  • width of SSID max 30 characters
  • Events used in the data are present in the study
  • Event repeat higher than 0, integer
  • CRF used in the data exists and is registered in given event
  • CRF version exists
  • Item name exists
  • group repeat is a positive integer
  • checks
  • validation rules
  • hidden/shown plus display-rule
@aderidder
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aderidder commented May 4, 2016

Patient Registration

  • Data of Birth
    • Check missing
  • PersonID
    • You're not allowed to use this parameter at all

Event Registration

  • uniqueness of Study Subject ID (SSID) within file
    • As you can register multiple events for a single SSID in one file, this check is wrong. It should be: within file for eventname - eventrepeat combination
  • Event Name
    • Check missing

Data File

  • uniqueness of Study Subject ID (SSID) within file
    • This should be: unique per event repeat (same as event registration)

Data checks

  • number of values allowed
  • controlled vocabulary
  • data type allowed
    • special checks for some datatypes (e.g. pdate format)
  • width
  • required

And don't forget the:
ignore empty fields or overwrite with empty data

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