Table 1.

Challenges and solutions related to designing and managing a biorepository system for a multi-site network

Challenge	Solution(s)
Designing a biorepository system that works for all stages of research	Expertise and buy-in at all levels (clinical, laboratory, biorepository, data management, statistical). Regular communication via a Laboratory Procedures Group to identify and solve problems and evolving issues in real time. A central statistical and data management center (SDMC) for specimen tracking and management, monitoring adherence to country- and site-specific regulatory requirements, and linking the clinical and laboratory data.
Flexibility to meet emerging research needs	Appropriate programming expertise at both the SDMC and the central biorepository. Both data management systems should accept multiple data formats and be quickly adaptable for including different data fields.
Obtaining high quality specimens from many types of clinical sites (from small clinics with little infrastructure or support to large research-based settings)	As much as possible standardize data collection and specimen collection, labeling and storage procedures. Minimize specimen processing at the clinical sites. Eliminate specimen-related data entry at the clinical sites. Use a bar-coding system for biospecimens with high quality labels and thermal label printers. Have pre-printed labels and pre-defined shipping schedules. Allow shipping boxes to include specimens of different types and from different studies. A well-designed and updated central website for information and training.
Preserving specimens collected specifically for future biomarker research (some assays are sensitive to collection and processing procedures)	Choose clinical sites that have the capability to collect and process specimens according to the study design. Document the conditions at the time of specimen collection (fasting status, time of day, quality of venipuncture, etc.) and during specimen processing (time from collection to processing, temperature during processing and storage, etc.) Documenting the conditions will allow future researchers to choose only specimens that were collected and processed appropriately for a particular assay.
Privacy protections for DNA specimens	Additional levels of privacy protection so that genetic information can not be linked back to a particular person, and appropriate security measures for the storage and use of sensitive data at the SDMC.
Logistics of specimen use at the biorepository (real-time testing, long-term storage, or batch testing)	An adaptable repository data management system (RDMS) that allows for real-time scanning and sorting of specimens. Using an electronic file provided by the SDMC before the specimens arrive, the RDMS alerts the technician when specimens should be used for immediate testing.
Protecting biospecimens as a valuable resource	A written specimen use procedure, including approval mechanisms for last vial use, using non-pristine (returned or leftover) vials when possible, and ensuring that specimens are returned to the biorepository.