Amendment 1 standard

Pinnacle 21 Support SDTM
1

Hi Joan,

Yes, we will include a separate specification file for the SDTM 3.1.2 Amend. 1 in the next release of OpenCDISC.

Regards,

Sergiy

2

I’m looking forward to the next release!

3

Hi Sergiy,

Do you have a timeline for the next release?

Regards,

Wei

4

Q1 2012

5

Hi,

FDA CDER and CDISC have released new documents for data submission last week (Dec. 2011), and CDER recommends implementation of CDISC’s “Amendment 1 to the SDTM v1.2 and the SDTM Implementation Guide V3.1.2.” Refer to FDA document at

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM254113.pdf

and refer to http://www.cdisc.org/sdtm to access the Amendment content.

Amendment 1 is released as “Version 1.0 Final” and contains added variables for DM, and events such as AE for MedDRA data in the parent domain (instead of in SUPPAE). However, if we implement the changes as CDER wishes, we will input variables that OpenCDISC won’t recognize and would flag as errors. So I’m wondering if OpenCDISC will be modifying the SDTM validation soon for the sake of recognizing the newly requested variables.

If not, I also saw mention in another forum question of a validator upgrade release expected sometime in Q1 2012. Will that expected update to OpenCDISC accommodate the new Amendment variables? Thank you very much for your help. It will help guide us in submissions we are working on now.

  • Joan