Table 1.

Other Challenges of Biobanking Specimens for Research.

Challenge	Recommendation
Clinical Annotation	Use Information technology (IT) to automate data entry and annotation of biospecimens as much as possible, to minimize errors. The more you can validate the clinical information, the more valuable is the biospecimen.
Data elements	Must be captured using standardized, coded, and discrete data elements; biospecimen distribution; retrieval, packaging, shipping and receiving must be carefully annotated. It is also important to document freeze- thaw events of each biospecimen.
Biospecimen Distribution	Validated SOPs must be used for retrieval, packaging, shipping, and receiving biospecimens. The freeze-thaw cycle is often very destructive if not properly performed and documented! The transport temperature must be documented. Beware of the “glass transition zone” or vitrification of samples. Vitrified tissue samples that undergo sudden cooling can turn into a solidified, “glassy” state characterized by ice formation in due to transient infringing of the Tg (glass transition temperature, −137C), which could lead to loss of the sample [12].
Integrated quality management system	Every biorepository process used from consenting to distribution needs to be documented with an SOP in an integrated quality management system for QC and QA.