Removal of SD0081

Hi Sandra,  SD0081 is a

Hi Sandra, 

SD0081 is a legacy check from WebSDM for specific data requirements used in some WebSDM reporting algorithms.

There are several problems with SD0081 check.

1. Unfortunately there are no detailed requirements on collection DS data. SD0081 check expects that DS domain has a record with date of Subject's End of Participation. It's information similar to represented in RFPENFTC variable introduced in SDTM IG 3.1.3. However there are no formal Standard or Regulatory requirements now. Some sponsors follow bad practice to not collect such information.

2. SD0081 check is very resource consuming. You cannot notice this due to overall high performance of OpenCDISC validator. However if your study have more than 50,000 subjects and 50,000,000 lab records you may expect very long validation time only due to this one check.

3. In most cases the SD0081 warnings are due to incorrect data collection design (see #1), rather than wrong data entry. You do not need to have thousands or millions reported records to identify this issue.

4. There are two similar checks. SD0080 and SD0082 work with AE and EX domains only. If data collection design does not include a date of subject's end of participation, then SD0080 and SD0082 will warn you about this in the same way as SD0081.

5. We will introduce a new check to compare all subjects dates vs. RFPENFTC. It's a more clear and more understandable formal requirement, but it's applicable only in new SDTM versions.

6. When SDTM standard and/or Regulatory requirements will require a presence of subject's end of participation records in DS domain, SD0081 check will be added back to validation specifications.

If you need SD0081 check for your internal data management process we can help you to configure validation specifications. Let us know.

Kind Regards, 

Sergiy