Regulatory Services
ICRC-Weyer provides the following regulatory services
- Submission of study documents to regulatory authorities & ethics committees
- Preparation of the CDISC Case Report Tabulation Data Definition Specification (define.xml, define.pdf), eCTD CRF annotation (blankcrf.pdf) and hyperlinking to define.xml as part of the eCTD Study Data Specifications for submissions to the FDA.
