SD1117/FDAC212 Duplicate records

Hi Wenchi,  Current version

Hi Wenchi, 

Current version of SD1117 check produces many false-positive messages. In particular it was not designed to handle Oncology domains.

We are improving the algorithm. Meanwhile, you need to

1. explain false-positive messaged in Reviewer Guide

2. clearly specify Domain Key Variables and describe them in define file. Note, that --SEQ cannot be Key Variable in subject data domains

3. run your own additional validation

Kind Regards, 

Sergiy

Dear Sergiy, Thanks for your

Dear Sergiy,

Thanks for your suggestion.

We will explain it in Reviewer Guide, and updated the Key Variables in define.xml file.

Best regards,

Wanchi

duplicate records

In my personal opinion, software validators should read the key varaibles from the define.xml file and deciide on whether a record is duplicate or not based on the key variables from the define.xml.

Essentially, define.xml contains the metadata of submission files and thus is leading.

Yes, it's correct. We are

Yes, it's correct.

We are changing a validation algorithm for our dupliate checks. A usage of define.xml as a source of study specific metadata is a part of it.

Kind Regards,

Sergiy 

Application to ADaM.

Hi Sergey, XML4Pharma, I understand that a SDTM validation check is discussed here. Just want to note that in case a similar approach will be applied to ADaM, in ADaM there is no strict requirement that key variables uniquely identify a record in a dataset:
ADaM 2.1 page 14:

KEY VARIABLES OF DATASET

A list of variable names that parallels the structure, ideally uniquely identifies and indexes each record in the dataset.