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. In Ontario, 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. The HICT program, 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:
Biospecimen SOPs:
- International Society for Biological and Environmental Repositories (ISBER);
- Canadian Tumour Repository Network (CTRNet);
- National Cancer Institute;
- OTRN.
Existing SOPs:
- Network of Networks (N2).
This successful collaboration has led to SOPs aimed to achieve standardization in Ontario to safeguard the quality of biospecimens for cancer research.
To access the set of biospecimen SOPs, click here
To access the set of biospecimen SOPs quizzes,click here
To access the set of biospecimen SOPs quizzes,click here
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.
Please contact Karen Arts for any comments or questions at karen.arts@oicr.on.ca
OTRN OICR Biospecimen Standard Operating Procedures
- OTRN OICR SOP001_01 Administrative Management
- OTRN OICR SOP002_01 Biospecimen Facility Maintenance and Security
- OTRN OICR SOP003_01 Biohazardous Waste
- OTRN OICR SOP004_01 Inventory Verification
- OTRN OICR SOP005_01 Specimen Shipping and Transportation
- OTRN OICR SOP101_01 Biorepository Team Roles and Responsibilities
- OTRN OICR SOP102_01 Biorepository Staff Training
- OTRN OICR SOP103_01 Informed Consent Forms for Biorepositories
- OTRN OICR SOP104_01 Informed Consent Process for Biorepositories
- OTRN OICR SOP105_01 Document Quality and Care for Biorepositories
- OTRN OICR SOP106_01 Database Set-up, Maintenance and Security
- OTRN OICR SOP107_01 File Transfer for Biorepositories
- OTRN OICR SOP108_01 Clinical Annotation for Biorepositories
OTRN OICR SOP109_01 Labelling and Tracking Materials for Biorepositories- OTRN OICR SOP110_01 Blood Collection for Biorepositories
- OTRN OICR SOP111_01 Blood Processing and Storage for Repositories
- OTRN OICR SOP112_01 Nucleic Acid Extraction from Blood Samples
- OTRN OICR SOP113_01 Tissue Collection and Transportation to Pathology
- OTRN OICR SOP114_01 Tissue Harvesting for Biorepositories
- OTRN OICR SOP115_01 Freezing Tissues for Biorepositories
- OTRN OICR SOP116_01 Preservation of Tissue Paraffin Embedding
- OTRN OICR SOP117_01 Sectioning of Paraffin and OCT Embedded Tissue
- OTRN OICR SOP118_01 Haematoxylin and Eosin Staining of Tissue Sections
- OTRN OICR SOP119_01 Nucleic Acid Extraction from Tissue
- OTRN OICR SOP120_01 Assessing Quality of Tissue Specimens
- OTRN OICR SOP121_01 Assessing Quality of Nucleic Acids
- OTRN OICR SOP122_01 TMAs from Paraffin Embedded Tissue Blocks
- OTRN OICR SOP123_01 Specimen Retrieval from Biorepositories
- OTRN OICR SOP124_01 Material Request and Release from Biorepositories
- OTRN OICR SOP125_01 Completing a Material Transfer Agreement
- OTRN OICR SOP201_01 Labelling and Tracking Biospecimens for Clinical Trials
- OTRN OICR SOP202_01 Destruction of Human Specimen Material
- OTRN OICR SOP203_01 Blood Collection for Clinical Trials
- OTRN OICR SOP204_01 Blood Processing and Storage for Clinical Trials
- OTRN OICR SOP205_01 Tissue Biopsy Collection and Processing for Clinical Trials
- OTRN OICR SOP206_01 Archival Tissue Request and Release for Clinical Trials
- OTRN OICR SOP207_01 Specimen Retrieval
Subscribe to us
100% Free.
close
0 comments:
Post a Comment