The archiving of clinical trial records is a required process linked to legal and regulatory obligations.
ECRIN joined EUCROF (the European Contract Research Organisation Federation) and eClinical Forum dedicated taskforce to develop a position paper that addresses the needs and practical directions for the archiving of clinical research in the present day.
In the position paper 11 key positions are put forth that address current issues where regulatory expectations vary from industry practices. The positions cover both issues related to the distributed nature of TMF and the decommissioning of computerised systems where archived data can be found.
Find the full position paper here