SD1201 Issue

Pinnacle 21 Support SDTM
1

Hi David,

I am not sure why are you receiving those false-positive messages. I validated a dataset you sent using a version of the validator available on our website.

My validation report includes 10 duplicated records in AE data. All of them look like real duplicates. E.g., records # 105 and 106. See all details in the excel file I emailed you this morning.

Please ensure that you use the same data as you sent to me, because your validation report shows 2 times more records in AE dataset, than it really has.

Regards,

Sergiy

2

Hello Sergiy,

I re-ran validation as indicated previously and these messages seem clear now. Not sure why I had that glitch earlier. I will get back to you asap

David

3

I get this error for duplicate subject, AEDECOD and start date

AEDECOD, AESTDTC, USUBJID Febrile neutropenia, 2011-11-17, EMTP-009046 SD1201 Duplicate USUBJID/AEDECOD/AESTDTC record
AEDECOD, AESTDTC, USUBJID Hypersensitivity, 2006-08-24, EMTP-009047 SD1201 Duplicate USUBJID/AEDECOD/AESTDTC record

When I look at the data I only see 1 record for each subject.

I send a copy of the data previously