- These guidelines do NOT necessarily apply to ALL trial specimens and all biobanks, as in some cases, biospecimen shipment did continue without interruption.
- These guidelines apply to Alliance Foundation Trials.
- These guidelines apply to both frozen specimens and ambiently stored biospecimens.
- These guidelines apply to biospecimens that were collected, (processed), and held per the usual protocol as well as specimens that were exceptionally processed on site for stabilization and subsequent shipment.
- if not done so already, all biospecimens should be logged into BioMS using actual / accurate collection dates.
- If biospecimens were exceptionally processed outside of the standard protocol, the specimen (in its original form) should still be marked as ‘collected’ in BioMS but with a note added as to how it was processed on site. For example- a 10 ml Streck tube of whole blood was collected but it was subsequently centrifuged, aliquoted, and frozen as plasma aliquots on site. The ‘Streck tube’ should be marked as collected and ‘shipped’ in BioMS, adding a note that the processed plasma vials are being shipped instead. Please indicate the number of processed vials in the shipment in your note.
- Each specimen collection event must include its own individual BioMS manifest, listing the specimens associated with that collection, just as it would have been collected and shipped in real time. It is permissible to physically ship specimens from multiple collection events in a single shipper, but each individual BioMS manifest for each collection must be included in the shipment.
- If sending multiple specimens from multiple patients and time points, it is important (per standard CSM instructions) that each biospecimen be physically labeled clearly and completely with the participant ID, biospecimen type (e.g. plasma or serum or buffy coat), and collection timepoint (if applicable).
- Be certain to include all applicable paperwork (pathology reports, questionnaires, forms) for all applicable specimens in the shipment, as per the protocol requirements.
- Frozen specimens and ambient specimens (e.g. paraffin blocks and slides) should be sent in separate shipments.
- If biospecimens are to be shipped to multiple biorepositories or analytical laboratories, make certain that the correct specimens are placed in the correct physical shipper with the appropriate destination address.
- Prior to any shipment, please call or email the destination biorepository or laboratory with the number of planned specimens to ship, and reserve a shipment date (it is assumed that delivery will be made by the following day). If you are unable to ship on the schedule date or need to cancel a shipment, please call or email to reschedule a date. This ‘reservation process’ is necessary to ensure that the biorepository is not overwhelmed with a large number of shipped specimens being received on the same day.
- All biorepository- or trial-specific rules with regard to shipments on Friday, Saturday, Sunday, or the day before a holiday apply (i.e. in most cases, biospecimens should not be shipped on Friday- Sunday or the day before a holiday).
- All biospecimens received will be reconciled and electronic feedback will be provided regarding any issues that require resolution, as per standard submissions.
- For questions about this general process, please call the AFT BioMS Help Desk at 1(855) 642-4667 OR email at firstname.lastname@example.org
- For specific questions about a shipment or pending shipment, or or to make a shipment reservation, please call or preferably email the destination biorepository or analytical lab, below: