Biorepositories: Addendum to Registries for Evaluating Patient Outcomes: A User’s Guide, Third Edition [Internet].

Although the linkage of patient registry data with biorepositories has great potential, there are many challenges that must be addressed in developing and operating a biorepository, as well as in linking data from biorepositories to registries. The purpose of this white paper is to provide an in-depth discussion of the use of biorepositories in medical care and clinical research, especially in the context of patient registries. This paper focuses on the use of biorepositories within the United States. Additional issues, including differences in regulatory environments, laws governing the import and export of samples, and cultural views on biospecimen collection, must be taken into account for repositories that collect biospecimens outside of the United States; a full discussion of these issues is beyond the scope of this paper. Where topics are well-covered in other materials, references and/or links are provided.

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