NIDDK Central Repository Specimen Submission Guidance

The Biorepository component of 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 required to submit resources, NIDDK-CR will cover shipping costs of specimens to the Biorepository. It is expected that projects will submit specimens in accordance with their approved Resource Archival and Sharing Request proposals. Coordinating Centers should review the specimen submission labeling, manifest, and shipping guidance prior to the pilot shipment (see the Resources for Specimen Submitters section below).

Specimen submission involves the following steps:

1. Selection of representative specimen archival set for future research use. This is intended to be a pre-planned (before specimen collection begins) estimate of all specimens to be collected during the study. A specimen archival set proposal, including the proposed specimen labeling structure, specimen metadata fields (to be included in the electronic manifest and/or vial label), and proposed shipment intervals must be submitted to NIDDK for approval in advance of participant enrollment.
2. Coordination and scheduling of pilot shipment(s) to identify trouble areas and provide an opportunity to address these ahead of specimen submission.

Procedures for submitting and accessioning specimens and corresponding service lead times are described below.

Stage 1: Specimen Submission Process

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 an electronic shipment manifest that adheres to NIDDK-CR specifications and the provided guidance (see the Resources for Specimen Submitters section below).

1. At least two weeks prior to the scheduled specimen submission date(s), the project staff will contact NIDDK-CR Biorepository support staff (niddk.mailbox@precisionformedicine.com) to request shipping supplies. They must also request accounts for access to BSI Engage.
2. When project staff are ready to ship specimens, on the day of the shipment, project staff must submit shipment notifications via BSI Engage. All required fields must be completed and the manifest uploaded as a CSV or Excel file.
   1. Please reference the Resources for Specimen Submitters section below for a manifest template.
3. 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.
4. For international shipments, project staff are required to notify NIDDK-CR Biorepository support staff no less than 48 hours prior to the shipment date to confirm that all necessary permits and commercial invoices have been secured. One week’s advance notice is strongly recommended.

Service Lead Times

NIDDK-CR provides the following turnaround estimates as minimum lead times for approved NIDDK-funded projects requesting shipping supplies from the Biorepository.

Stage 2: Specimen Accessioning Process

Once the Biorepository receives the specimens, they will start the accessioning process described below:

1. 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 waiting to be inventoried. If the specimens cannot be inventoried immediately, they are placed in temporary storage at the appropriate temperature.
2. During accessioning, specimens are checked and 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 accessioning is complete.
3. NIDDK-CR Biorepository has mandatory minimum information (metadata) that must be submitted for each specimen, including specimen ID, barcode number, date of collection, visit, specimen type, study/protocol, and volume. Specimen metadata are uploaded to the inventory database.
4. Specimen inventory (meta)data are uploaded to the NIDDK-CR website, Resources for Research (R4R), within one week of specimens being accessioned.
5. NIDDK-CR Biorepository makes every effort to accession specimens as quickly as possible. It may take up to three weeks from the day of receipt to accession 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 in the Service Lead Times table below.

Service Lead Times

NIDDK-CR provides the following turnaround estimates as minimum lead times for accessioning incoming specimen shipments from projects.

Resources for Specimen Submitters

Specimen Submission Label, Manifest, and Shipping Guidance - Guidance for specimen labeling and shipping collections to NIDDK-CR.

Example of Specimen Submission Manifest - Example shipping manifest for submitting specimens to NIDDK-CR.

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