The biorepository component of the NIDDK Central Repository (NIDDK-CR) stores and makes available biological specimens generated by current and concluded clinical studies funded by or within the mission research areas of NIDDK. Before study generated resources can be submitted, projects must be approved to deposit in accordance with NIH, NIDDK, and NIDDK-CR policies, practices, and procedures. After approval, projects must coordinate a pilot shipment and address any identified trouble areas before scheduling future shipments. For projects that are required to submit resources, NIDDK-CR will cover the costs of shipping biospecimens to NIDDK-CR biorepository. It is expected that projects will submit biospecimens in accordance with their approved Resource Archival and Sharing Plan. Procedures for submitting and accessioning biospecimens after the initial pilot shipment are described below.
The biospecimen submission process involves the following steps:
After a project is approved to deposit biospecimens into NIDDK-CR Biorepository, the study team will coordinate with the biorepository support staff to create vial labels and electronic shipment manifest that adhere to NIDDK-CR specifications and provided guidance.
At least two weeks prior to the scheduled biospecimen submission date(s), the project staff will contact the NIDDK-CR biorepository support staff (niddk.mailbox@precisionformedicine.com) to request shipping supplies.
When project staff are ready to ship biospecimens, on the day of the shipment, project staff must send a shipment notification to the NIDDK-CR Biorepository via email at niddk.mailbox@precisionformedicine.com. The notification should include the study name, air bill/tracking number(s) and attached shipment manifest as a CSV or Excel file.
Frozen shipments should be shipped Monday through Wednesday to avoid weekend shipping delays. Refrigerated shipments may be shipped Monday through Thursday. NIDDK-CR Biorepository will notify the project staff when shipment is received and the condition of the shipment and biospecimens.
The biospecimen accessioning process involves the following steps:
When a biospecimen shipment arrives, the package is opened and checked for damage and accidental thaws. All biospecimens received are kept as close to their appropriate storage temperature as possible while awaiting to be inventoried. If the biospecimens cannot be inventoried immediately, they are placed in temporary storage at the appropriate temperature.
During inventory, biospecimens are checked; their barcode labels are scanned into the inventory tracking system and assigned a permanent storage location. All biospecimens are placed in their permanent storage location at the appropriate temperature when inventory is complete.
NIDDK-CR biorepository has mandatory minimum information (metadata) that must be submitted for each biospecimen, including but not limited to biospecimen ID, barcode number, date of collection, visit, specimen type, study/protocol and volume. Biospecimen metadata are uploaded to the inventory database.
Biospecimen inventory (meta)data are uploaded to the NIDDK-CR website, Resources for Research (R4R) within one week of biospecimens being accessioned.
NIDDK-CR Biorepository makes every effort to inventory biospecimens as quickly as possible. It may take up to four weeks from the day of receipt to inventory biospecimens and for data to be visible on the NIDDK-CR R4R website. Large or mass shipments or shipments with multiple biospecimen-level discrepancies may take longer.