New born Child/Neonate Guidance Needed for SDTM Mapping

v venkat

on September 17, 2024

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.

Forums: SDTM

j Jozef

on September 20, 2024

Need some guidance on mapping data for newborns/neonates

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: https://www.linkedin.com/groups/2758697/
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.