Review: Lab Sample Storage and Clinical Trials

Review: Lab Sample Storage and Clinical Trials

Lab sample storage for clinical trials is maybe one of the areas, which clinical trials teams neglect. However, often inadequate storage could result in audit findings.
Unless the clinical trial requires lab samples to be sent to Central Lab for analysis the same day, usually the lab samples are stored in local facility.
What are the common issues with lab sample storage?
  • Inadequate labeling – if the lab samples are not labeled correctly, they can be mixed up during the storage. This could compromise significant amount of lab sample data.
  • Lack of temperature monitoring – this is a common issue. Lab fridges used to store lab samples should have temperature monitoring and temperature deviations should be reported to the Sponsor. Clinical trials team should have back-up plan in case of fridge faults.
  • Samples stored at wrong temperature – always check you lab manual to assure the samples are stored at correct temperature and data is not compromised.
  • Lab fridges used to store different materials – this is another common issue. Ideally lab fridges should be used only for clinical trials samples, however if this is not possible, shelves with samples should be clearly marked.
  • Extensive storage – sometimes lab samples are stored longer than lab manual recommendations. It is desirable lab samples to be sent on a regular basis to Central Lab to avoid compromising samples.
  • Back-up samples – often studies require back-up samples to be kept locally, however it is common that these samples are missed or misplaced.
How to avoid lab storage issues?
  • Make sure you have procedure for clinical trials lab sample storage and contingency plan in case of faults.
  • Make sure you have adequate temperature monitoring system and readings are taken regularly.
  • Keep samples from different patients and clinical trials clearly labeled and separated.
  • Send samples to Central Lab regularly and check if your back-up samples are properly labeled.
Published on 
04 January 2016
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: Common issues with lab samples handling in clinical trials

Review: Common issues with lab samples handling in clinical trials

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 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.
Published on 
23 November 2015
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: How to ship lab samples in clinical trials?

Review: How to ship lab samples in clinical trials?

Majority of the clinical trials use external facilities for lab samples analysis and storage. These facilities are knows as Central lab and they are specific for each region (for example, Europe, Asia, South America, etc.).
Some clinical trials may not require lots of lab samples, however majority of the studies have very complex lab samples requirements. The most common sample requirements are hematology and chemistry panels, but usually there are study specific sample requirements.
One of the challenges in lab samples handling is that often there are different samples, which should be stored and shipped under different conditions. The most common shipping requirements are: dry ice, ice packs and ambient temperature.
What do we need to know about lab samples handling health and safety?
  • Dry ice is used for frozen lab samples. It is toxic material and should be handled carefully. People who handle dry ice lab samples should have a special training, usually provided by the hospital or certified agency. Normally dry ice is ordered from the courier 24 hours prior shipping samples. Each clinical trial has specific dry ice order form.
  • Ice packs are used to keep samples chilled but not frozen. They are safe to use and should be refrigerated overnight before shipping. Usually ice packs are provided by Central lab with lab kits.
  • Ambient samples are shipped at room temperature.
Lab manuals have detailed information regarding each sample shipping requirements. It is important that these instructions are followed carefully and samples are not compromised.
What are the common issues with lab samples shipping?
  • Samples sent in a wrong shipping box, which results in a delayed delivery or return to the site.
  • Inadequate labeling – missing dry ice label, category B label, etc.
  • Samples arrived on melted dry ice due to delay.
  • Samples shipped at wrong shipping conditions.
  • Samples shipped with inadequate documentation – missing proforma invoice, etc.
How to avoid shipping mistakes?
  • Lab samples should have the appropriate labeling on the shipping box. Always use the provided shipping boxes for the study to avoid confusions. Always follow the instructions for packaging of ambient, refrigerated and frozen samples.
  • Samples shipped on dry ice should always have dry ice label clearly displayed – UN1845.
  • Make sure you have “Next day delivery” label for samples shipped on dry ice, otherwise delivery could be delayed and dry ice will melt.
  • If you have mix of ambient, frozen and refrigerated samples, always refer to you Central lab manual to avoid mixing up the samples.
  • Make sure you have all proper documents for shipping samples. Missing proforma invoice or other information could cause delivery delays.
  • Always consider weather conditions – during hot summer days or cold winters there may be different shipping recommendations and you need to check with Central lab and courier to avoid compromising your samples. These temperature deviations are especially important for ambient samples shipping.
Published on 
2 November 2015
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.
Review: Clinical trials – How to simplify vendor manuals?

Review: Clinical trials – How to simplify vendor manuals?

 

Few years ago a nurse working on clinical trial contacted me to ask about simple instruction on how to send X-ray images to external vendor. I sent her e-mail with 5-step instruction and attached the form she needs to complete. She rang me few minutes later and said, “This is brilliant! But if it is so simple why there is a 40 page manual for this?” This is indeed a valid question.
There are lots of different manuals in clinical trials and all of them are quite extensive and detailed. Vendors always try to include as much as possible information and cover all possible questions but the result is a huge manual that clinical trials teams do not have time to read.
What are the common problems with manuals?
  • Vendor training provided is too long and with too many details and clinical trials teams do not remember all requirements.
  • When the study is initially set up there was not enough training provided during the site initiation visit.
  • Vendor support team is not providing adequate guidance on specific questions and often refers clinical trials teams to the manual provided.
  • During the initial set up clinical trials teams have to go through hundreds of pages to find out how to ship lab samples, register patients in IVRS, enter data, send images, etc. This is very time-consuming process.
  • When a team member is not at work or has left, the new team member has to spend the same amount of time to go through all manuals to identify what is required.
What can be done to safe time for clinical trials teams?
1. Ask the vendor support team to provide simple step-by-step instruction for the procedure. This is their process so they should be able to explain what is required.
2. Keep simple instructions in a study specific folder on your server so your colleagues could find it easily if needed.
3. Once you have gone through the process create a simple procedure that could be used by the whole team.
4. Ask your administrative support to help create a simple procedure.
5. Communicate the procedure to your colleagues.
6. Check if there is a simple way of doing things – is it possible to send the required information online which will be easier and faster?
7. Do not forget to add any specific tips or requirements.
Published on 
12 July 2014
Author: Olga Peycheva, Director at Solutions OP Ltd. 
Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe.