The biorepository component of the NIDDK Central Repository (NIDDK-CR) stores and makes available 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. All resources must be appropriately consented for secondary research use (example language can be found under the “For Submitters” tab “Example Language for Informed Consent"). 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 specimens to NIDDK-CR Biorepository. It is expected that projects will submit specimens in accordance with their approved Resource Archival and Sharing Request. Procedures for submitting and accessioning specimens after the initial pilot shipment are described below.
The specimen submission process involves the following steps:
After a project is approved to deposit specimens 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 specimen 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 specimens, 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 specimens.
The specimen accessioning process involves the following steps:
When a specimen shipment arrives, the package is opened and checked for damage and accidental thaws. All specimens received are kept as close to their appropriate storage temperature as possible while awaiting to be inventoried. If the specimens cannot be inventoried immediately, they are placed in temporary storage at the appropriate temperature.
During inventory, specimens are checked; their barcode labels are scanned into the inventory tracking system and assigned a permanent storage location. All specimens 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 specimen, including but not limited to specimen ID, barcode number, date of collection, visit, specimen type, study/protocol and volume. Specimen metadata are uploaded to the inventory database.
Specimen inventory (meta)data are uploaded to the NIDDK-CR website, Resources for Research (R4R) within one week of specimens being accessioned.
NIDDK-CR Biorepository makes every effort to inventory specimens as quickly as possible. It may take up to four weeks from the day of receipt to inventory specimens and for data to be visible on the NIDDK-CR R4R website. Large or mass shipments or shipments with multiple specimen-level discrepancies may take longer. More information can be found under Service Lead Times page.