One lesson learned from the GTEx pilot study is that there is not a “one size fits all approach” to SOP development for biospecimen procurement; this lesson was largely based on institutional differences, many of which were unavoidable. The BSSs were consulted when new SOPs were developed to ensure that the SOPs were operationally feasible. Document control software was also utilized to ensure that current versions of SOPs were being used and training was conducted to ensure comprehension of new procedures. Approximately 100 supporting quality documents were developed to provide consistency and clarity to this complex project. Many of these documents are available to the public, including SOPs, workflows and project-related tools (http://biospecimens.cancer.gov/resources/sops/library.asp).
