This Self-Assessment-Survey from BBMRI-ERIC allows users (from e.g. laboratories, biobanks) to assess compliance of their pre-analytical procedures
with the following 10 CEN Technical Specifications (CEN/TS) and ISO Standards!
Evaluate your pre-analytical sample handling processes - does your lab meet the pre-analytical CEN/TS & ISO Standards' requirements?
To find out, use the BBMRI Self-Assessment Surveys for
- General Requirements for Biobanking; ISO 20387:2018
- Frozen tissue - Part 1: Isolated RNA; ISO 20184-1:2018
- Frozen tissue - Part 2: Isolated proteins; ISO 20184-2:2018
- Frozen tissue - Part 3: Isolated DNA; ISO 20184-3:2021
- FFPE tissue - Part 1: Isolated RNA; ISO 20166-1:2018
- FFPE tissue - Part 2: Isolated proteins; ISO 20166-2:2018
- FFPE tissue - Part 3: Isolated DNA; ISO 20166-3:2018
- Venous whole blood - Part 1: Isolated cellular RNA; ISO 20186-1:2019
- Venous whole blood - Part 2: Isolated genomic DNA; ISO 20186-2:2019
- Venous whole blood - Part 3: Isolated ccfDNA from plasma; ISO 20186-3:2019
- Metabolomics in urine; CEN/TS 16945:2016
Software template for documentation of pre-analytical data
Documentation of pre-analytical data is state-of-the-art and good scientific practice!
Several CEN/TS and ISO standards for pre-examination processes exist that require the documentation of pre-analytical data from human specimens and samples.
Also, the In Vitro Diagnostics Regulation explicitly mentions pre-analytics and requires pre-analytical data in the technical documentation for in vitro diagnostic devices.
In order to support researchers in their efforts to optimize their pre-analytical workflows, BBMRI.at in collaboration with SPIDIA4P (H2020, grant no. 222916), Biobank Graz, and
CyBiobank (H2020 grant no. 8571222) developed a software template for the documentation of pre-analytical data. It is based on REDCap as IT framework and on the ISO Standards
as source for pre-analytical requirements.
Download free software template for pre-analytical frozen tissue!
The software can be downloaded as file and shall serve as a template that can be adapted by the users (familiar with REDCap) to local / individual needs.