The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations. A group of industry experts coalesced under EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research.
The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities.
Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed among sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.
This position paper highlights 11 key positions about archiving given the distributed nature of the TMF, and the archiving of data from computerised systems to allow those systems to be decommissioned when they are no longer required in the trial. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.
21_02_24_Archiving_Position_Paper_version_A.pdf
The position paper has been written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA. The task force has included representatives the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry.
The European Contract Research Organisation Federation (EUCROF) consists of members from most European countries and partner members from nearby countries with the aim of promoting clinical research of high quality in Europe in general and in the European Union in particular. For further information visit the website at www.eucrof.eu.
The eClinical Forum (eCF) is a global not‐for‐profit and non‐commercial, technology independent group representing members of the pharmaceutical, biotechnology, and allied industries. The eClinical Forum’s mission is to serve these industries by focusing on those systems, processes and roles relevant to electronic capture, management and submission of clinical data. For further information visit the website at www.eclinicalforum.org.
March 2, 2021
