Collecting lab samples for clinical trials could be very complex depending on the study. Some studies require lots of different samples to be collected and processed, which could take significant amount of time. Additional documentation and labeling could be extra burden for clinical trials teams. However, once the team gets used to the study, sample collections become easier or at least not so confusing.

The process of samples collection, processing, storage and shipping is described in Central lab manual. But sometimes Central lab manuals could be confusing and need extra time to identify the correct process and samples collection.

The minimum labeling requirements for lab samples is to have study number, patient’s randomization number and visit date. However, some labels may require collection time as well.

What are the common issues with lab samples handling?

  • Wrong collection tubes used – this could be result of confusing colour caps. 
  • Wrong visit labels – it is common issue clinical trial teams to use unscheduled lab sample instead of specific visit label.
  • Wrong patient’s number – this is another issue, especially when a few patients attend for their appointment at the same date.
  • Missing information – often there are missing visit dates or collection times.
  • Wrong storage conditions – this is common issue, especially in clinical trials with lots of samples that require different storage (ambient, refrigerated and frozen).
  • Expired lab kits used – this is a very common problem. Sometimes different tubes in the lab kits have different expiration date and this could cause serious confusions.
  • Wrong samples collected – in some clinical trials there are sub-studies, which require additional lab samples, however not all patients would consent to participate in the sub-study but the clinical trial team has collected samples in error.
  • Missed samples – another common problem in clinical trials, especially at the end of the study.

Sample collection issues could have significant impact on data collection and final analysis of the study results. Inadequate sample collection could result of destroying lots of samples, which otherwise would be used for study drug profile analysis. This is why it is critical clinical trials teams to do their best to avoid errors. 

How to avoid lab sample errors?

  • Always make sure patient is consented prior sample collection. In case of sub-study, make a list with patients who have consented to participate in the sub-study, in order to avoid confusions.
  • Always check which samples have to be collected prior patients’ appointments.
  • Prepare tubes and labels in advance if you have several patients attending clinic at the same time. 
  • Use provided spreadsheets or trackers to document visit date and collection time. 
  • If you are collecting lab samples for the first time for this study, make sure you have reviewed the Central lab manual in advance and you know which tubes to use.
  • If you have to collect different samples that require different storage conditions, try to separate them or label them in advance.
  • Always check expire date on your lab kits and tubes and discard expired kits as soon as possible to avoid confusions.
  • Do not forget to document sample collection on worksheets or in source data. If it is not documented, later on it will not be clear if the sample was collected.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 23 Nov 2015