De-Identification of biological samples – successfully overcoming the challenges

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The de-identification of biological samples is crucial when a clinical trial sponsor wants to perform analysis without any preconceived ideas related to the sample data. The challenges lie in creating randomized data files with new sample identifiers, maintaining the integrity of samples, guaranteeing traceability, and managing blinded and unblinded data.

The major risk in the de-identification process is that the wrong new label is applied on a tube after its delabeling, which results in the traceability between the data and the tube being lost. Labeling errors are undetectable and will have a great impact on trial results.

CSM has over 19 years of experience in the management of biological samples. Having managed Millions of samples, for small studies to global, long-term trials we can ensure your trial is a success, regardless of size or scope.

Our proprietary CSM Sample Data System has a tried-and-tested de-identification module. The database allows the recording of sample data (up to 19 fields), creation of new codes and labels one by one -avoiding any risk of mislabeling of the samples- and the removal of blinded data, which ensures that the packing list only contains data that can be shared with the lab.

The CSM process is fully secure in terms of traceability and has a built-in quality control, visual checks, to ensure the correct label is removed/applied.

PROVEN TRACK RECORD OF SUCCESS

The de-identification process requires procedures to handle the samples safely, adequate labeling materials, a strong IT system to manage the allocation of old and new identifiers, blinding of data and keeping the original data behind the scenes.

With the CSM Sample Data System we have everything in place to successfully manage the de-identification of biological samples, no matter what the project specifications are:

  • For one client we received randomization lists for over 150,000 samples and uploaded them into the de-identification module of our database, we then relabeled a few hundred of these samples that the client decided to ship
  • We blind certain data (e.g. date of birth, patient name) on tube labels or requisition forms and erase specific data in our database to adhere to the privacy laws in countries worldwide.
  • For another client, we provided the full range of our services for over 10,000 samples. We created a randomized data file with new sample identifiers, uploaded the new data in our database, replaced the tube labels via scanning of old and new labels, erased some of the original data to avoid the labs receiving unwanted data, and kept the link between old and new data to aid the trial sponsor if needed.

De-identification of sample data is complex. It is essential to have the right tools, processes and checks in place to avoid compromising the biological samples and, ultimately, the clinical trial results.

How can we help your project? Schedule your 20-minute, no-cost consultation with a clinical supplies services expert at CSM.