Scientists have been using human specimens for centuries in their quest to understand the nature of human diseases. Yet, it is only recently that medical researchers have begun to appreciate the growing evidence that the molecular profile of a biospecimen may be significantly impacted by the condition of the patient at the time of specimen accrual and by subtle differences in specimen handling. Scientists are currently developing research protocols that increase consistency in specimen handling to improve the quality of results. The purpose of this chapter is to review critical considerations that should be made when performing research using patient samples (human specimens collected for research) and to provide guidance on how those samples most effectively can be collected and processed, and finally, how processing procedures can be documented and reported to allow for scientific evaluation of findings and support the reproducibility of the research outcomes in subsequent studies.
|Title of host publication
|Principles and Practice of Clinical Research
|Number of pages
|Published - Jan 1 2018
- Fit for purpose
- Preanalytical variable
- Standard operating procedures