**2.3 Monitored storage of biological samples and distribution**

In relation with sample conservation, derivatives are long-term stored in the most appropriate conditions to maintain their original characteristics, being very important for the sample stability the selection of the temperature storage [15]. When samples are receipted in the storage facilities, aliquots are immediately revised to check the shipment temperature; the number, integrity, and volume of each aliquot regarding the expected; and incidents reported, maintaining the cold chain. Racks and boxes are previously prepared to directly store the derivatives in a reduced and optimized space within the conservation equipment classified by the type of container. In addition, derivatives are preferably stored separately in different equipment and preservation rooms as a safety measure.

So, long-term storage facilities may be located in one or more rooms or buildings and may even be assumed by several institutions when transportation of samples and temperature variations are minimized. In any case, sample handling and positions must be under control and restricted access. Both the preservation rooms and storage equipment are constantly controlled through a monitoring system that records critical parameters such as temperature, humidity, CO2, and O2 levels (where necessary) and the proper functioning of equipment (compressors, battery power, display) (**Figure 2**). The system triggers an alarm when any parameter is out of the established range, thus activating an emergency plan. Briefly, warnings are received by specifically dedicated staff available for 24 h who analyze and classify the failure to initiate the defined corrective actions. In case it could not be repaired, samples are evacuated to backup equipment.

If previous instructions are followed, samples could be preserved in good conditions for a long time. However, the specific period of time will depend on the type of sample but, most importantly, on the biomarker to be detected by a particular methodology, with a range from minutes to years [15]. In this sense, fitness-for-purpose procedures should be validated and established when a prospective workflow is designed, taking into consideration the general good practices that do allow the most use of samples [2, 12]. Independently, other approaches have been reviewed for the conservation of samples at room temperature by biobanks [25].

**171**

*tubes.*

**Figure 3.**

*Harmonized and Quality Sample Handling in Biobank-Supported Multicenter Prospective Studies*

Before sending of samples to analytical laboratories from the storage facilities, a checkpoint is introduced to guarantee that each aliquot is compliant with the corresponding study or with the necessary volume of sample to thus supplement with additional aliquots. Additional quality controls should be performed when incidents during the sample conservation occur or after a non-validated long-term storage. The remaining precious samples may be again received for long-term storage from

The electronic database used by biobanks allows the integral management of multicenter prospective projects with a maximum level of security through restricted access. Donors, biological samples, and associated information, as well as the ethical-legal documentation associated to the project, are recorded. In detail, the system allows an exhaustive control of collaborating centers and researchers, preparation of sample collection kits maintaining the traceability of all materials used, donor and clinical information, informed consent forms, ethical and scientific committees' approvals, agreements, sample handling by different sites (reception, processing, storage and shipments), quality incidents, and even the project monitoring by using any recorded information, for example, the recruitment rates from each clinical site. The electronic database may be also connected to external databases incorporating additional information such as temperature information from storage equipment. So, traceability is achieved

*Identification of samples and materials with structured codes and representative box map with pre-coded* 

*DOI: http://dx.doi.org/10.5772/intechopen.90947*

**3. Traceability of biological samples**

**3.1 Electronic database**

from all the processes.

the testing laboratories followed by a new quality control.

**Figure 2.** *Representative graph of a monitoring system showing a temperature of an ultra-freezer at −80°C.*

*Harmonized and Quality Sample Handling in Biobank-Supported Multicenter Prospective Studies DOI: http://dx.doi.org/10.5772/intechopen.90947*

Before sending of samples to analytical laboratories from the storage facilities, a checkpoint is introduced to guarantee that each aliquot is compliant with the corresponding study or with the necessary volume of sample to thus supplement with additional aliquots. Additional quality controls should be performed when incidents during the sample conservation occur or after a non-validated long-term storage. The remaining precious samples may be again received for long-term storage from the testing laboratories followed by a new quality control.
