Biospecimen Standard Operating Procedures and Quiz
The availability of high quality biological specimens is of utmost importance for cancer clinical trials and research. Standardizing methods for collection, long-term storage, retrieval and distribution of specimens across collection sites is essential to ensure the quality of the samples and enable consistent analysis of DNA, RNA and proteins. Whereas regulations exist to provide direction in many aspects of clinical research conduct, to date there are no formal regulations that direct the collection, and management of biospecimens. In the absence of such regulations, common Standard Operating Procedures (SOPs) are an ideal tool to establish standardization for repositories and clinical research sites. While many samples are collected across a multitude of sites, lack of standardized methods and lack of consistent SOPs jeopardize quality of the samples and the ability to use the samples for future research. In collaboration with the Ontario Translational Research Network (OTRN) facilitated a collaborative effort to modify, harmonize and expand existing biospecimen SOPs.
The OICR-OTRN SOP committee wishes to acknowledge and thank the following organizations for access to review their materials:
- International Society for Biological and Environmental Repositories (ISBER)
- Canadian Tumour Repository Network (CTRNet)
- National Cancer Institute
- Network of Networks (N2)
This successful collaboration has led to SOPs aimed to achieve standardization to safeguard the quality of biospecimens for cancer research.
The SOP set is organized into three levels:
- Overall General SOPs (000 series) to guide both clinical trials and biorepositories;
- Biorepository SOPs (100 series);
- Clinical Trial related SOPS (200 series)
In addition to this “overarching” set, to be adopted by each site to guide the overall practice, each site may develop additional SOPs, appendices and/or tools to complement this set to outline specific local details.
Any clinical trial related matter that is not unique to biospecimens is outlined in the Network of Networks (N2) SOPs. These can be accessed through N2. Upon completion of reviewing all SOPs, the reader can complete the quiz to test his or her understanding of the SOP. The justification is provided a separate document. The completed document can be kept on file to satisfy regulatory or educational requirements.
OICR Biospecimen Standard Operating Procedures
- OICR Table of Contents
- All OICR Biospecimen Standard Operating Procedures (ZIP file)
- Archived biospecimen SOPs