Pharmacogenetics evaluations/findings

Pinnacle 21 Support SDTM
1

Hi Dmytro,

Siblings and Donors information should be submitted using Associated Persons domains.

https://www.cdisc.org/system/files/all/standard_category/application/pdf/sdtmig_ap_v1.0.pdf

https://www.pharmasug.org/download/sde/rtp2016/PharmaSUG_RTP2016SDE_02_Stackhouse.pdf

https://www.lexjansen.com/pharmasug/2016/DS/PharmaSUG-2016-DS10.pdf

For HLA Evaluation see CDISC PGx Pharmacogenomics Standard and PF domain

https://www.cdisc.org/standards/foundational/pgx

https://www.cdisc.org/sites/default/files/education/webinar/public/CDISC%20PGxIG%20Presentation%202014-Nov-20.pdf

https://www.lexjansen.com/pharmasug/2017/DS/PharmaSUG-2017-DS05.pdf

Kind Regards,

Sergiy

2

Thank you, Sergiy!

3

Dear colleagues,

Could you please help to map following eCRF pages: Subject HLA Evaluation, Sibling Donor Evaluation, Unrelated Matched Donor Evaluation? What should be the domains for them?

Thank you!