#26 Practical RWE – Data Retention and Archiving


Data retention and archiving in non-interventional studies (NIS) are foundational practices that support the integrity of the scientific process, comply with regulatory requirements, facilitate future research, serve educational purposes, and ensure ethical management of study data. These practices are essential for advancing knowledge, fostering innovation, and ultimately improving health outcomes.

In many jurisdictions, regulatory bodies mandate the retention of research data for a specified period (see below).

Argentina = 2 years
Austria = 15 years
Brazil = 5 years
Germany = 10 years
Japan = 5 years
Netherlands = 15 years
South Korea = 3 years
Turkey = 5 years

Pain Point #1 = Most countries don’t define how long you should retain NIS  documents. In these cases, we recommend you defer (refer) to IPSE GPP data retention guidance = At least 5 years after final report or first publication of study results.

Pain Point #2 = Trying to force your non-interventional (observational)  study documents into a filing system designed specifically for clinical trials. There is a (reasonably) simple solution for this.  Use the real world study document index that was developed from the TMF Reference Model by NIS experts who were keen to mitigate this pain.

CDISC Real World Study Document Index: https://www.cdisc.org/sites/default/files/2023-09/Real_World_Studies_Document_Index_v1_2020_07_29.xlsx

CDISC TMF Reference Model: https://www.cdisc.org/tmf

In conclusion, through adherence to established guidelines and the utilization of resources like the CDISC Real World Study Document Index, researchers can navigate the complexities of data retention, thereby contributing to the broader goals of enhancing knowledge, spurring innovation, and improving global health outcomes.

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