New born Child/Neonate Guidance Needed for SDTM Mapping

Pinnacle 21 Support SDTM
1

This is a forum about the use of P21 Community, not about SDTM mapping knowledge.
The better choice is to use the LinkedIn “SDTM Experts” forum: LinkedIn Login, Sign in | LinkedIn
which has over 3,300 particpants, including most of the developers of the SDTM-IGs and SDTM trainers.
If you post your question there, you usually get answers within a few hours.

2

Need some guidance on mapping data for newborns/neonates.

Study Details:

  • Enrolls only pregnant participants

  • Includes seprate CRF pages collecting data on neonates/newborns

  • Separate unique subject numbers assigned to neonates

Specific CRF pages for neonates/newborns:

  1. New Born General Examination

  2. New Born General Status

  3. AE (for Neonate/Infant) etc

We would appreciate input on the Guidance on mapping data for newborns/neonates in SDTM (We are currently referring to cdisc Associated Person’s IG). In the CRF, Neonates/New Born’s are also assigned a separate Subject Number.