What is it? Why is it important?
- Is complete (e.g. all fields entered)
- Is consistent (e.g. all required information on Biological Material (BM) characteristics is registered)
- Is coherent (e.g. no false or missing entries)
- Is correct when migrated from an external data source (e.g. data imports are correct and validated)
Data monitoring can include:
- Full-checks, where all entered data is screened
- Spot-checks, where only selected data is verified
- Automated checks, where BIMS uses entry checks with error messages if entries do not comply with requirements (e.g. the use of software solutions that allow for the computation of automate checks)
Full-checks can be both expensive and time consuming. Spot-checks should be risk-based, by focusing on data entries with a high error risks (e.g. manual entries, data migrations or imports).
Automated checks are very useful to improve data quality, but require IT expertise and programmable software solutions for its implementation.
What do I need to do?
For your BIMS:
- Plan data monitoring procedures prior to setting up your database. Focus on:
- Data with an increased risk of errors, and that require increased monitoring (e.g. based on risk assessment)
- The use of data entry acceptance criteria to reduce data entry errors
- The frequency of data monitoring (e.g. once a month, quarterly, or based on data volume). Allow frequency to be adapted based on the frequency of recorded errors (e.g. in the non-conformities log)
- Define how to document data monitoring in BIMS (e.g. monitoring report, non-conformity report, Risk Assessment Form (RAF)). Include follow-up procedures such as the implementation of risk control-measures
- Define responsibilities (e.g. who enters and/or monitors the data, who approves/implements potential improvement measures)
- Describe your data monitoring strategy in a SOP or monitoring plan and train staff
Monitoring should include the interface between BIMS and storage of BM, such as:
- Correct location: BM documented in BIMS correlate with their physical location in the biobank (e.g. in freezers, shelf and box)
- Correct inventory: BIMS correlates with available-, analyzed-, and destroyed BM, including biobank storage free space
Interface monitoring between BIMS entries and BM storage in biobank repositories:
- Randomly select a set of samples in BIMS (e.g. 5 samples frozen and stored in a -80°C freezer)
- Extract from BIMS their storage location in the -80°C freezer
- Physically open the -80°C freezer and locate samples based on data provided by BIMS
- Document any mismatch as a non-conformity and perform a root cause analysis
- As applicable, implement improvement measures (e.g. staff trainings)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Quality control strategy implementation SOP
- Quality control results
- Sample tracking form
- Non-conformity log
- Non-conformity report