BIOREQ: Model Requirements for the Management of Biological Repositories
BioReq is a comprehensive guideline which covers the full range of research and operation activities applicable to biological repositories or biobanks.
This Guideline is intended to be used for the following purposes:
As the basis for creating a custom Standard Operating Procedures (SOP) Manual: the requirements presented in this Guideline can be transformed into SOP statements. Using the Guideline as a basis of SOP guarantees that all relevant areas are covered.
As a checklist of standards compliance: This Guideline incorporates ISO, OECD and NCI recommendations which apply to the operation of biorepositories. Since each requirement articulates a single recommendation which is either adhered to or not, there is no need for a separate audit checklist.
To guide the design and development of Biobank Software Systems (BSS): software vendors can rely on this Guideline as an aid to guide product development.