Facilitated by Alan Yeomans, Pharmaceutical Consulting Group
Regulatory requirements exist that require the archiving of the eCRF, EPRO/ECOA and eTMF data and metadata for at least 25 years after the submission of the trial data to the authorities, sometimes longer. Regulations state that it is the responsibility of the investigator to archive all data and metadata from their site, and the responsibility of the sponsor to archive other study related information. The current practice of archiving all electronic data and metadata on DVDs or Blu-rays is no longer tenable – modern computers come without disk readers.
This BoF looks to set up a discussion of possible alternatives and how practical they are. Participants are encouraged to share their ideas and experiences!!
This BoF Discussion is for eCF Members only. Please contact firstname.lastname@example.org for additional information on registration to this event or membership.