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Background and overview

Distribution Protocols are created to capture important information regarding the distribution of samples to collaborators or to track samples sent for processing at cores that won’t be returned (like sending an aliquot for NGS that won’t be returned to you). Creating a Distribution Protocol with the important details as outlined in this document ensures that all necessary information is captured for future reference (i.e. audits), but also allows for multiple shipments over time to the same project without having to reenter all of the information.

Distributed: Specimens are considered ‘distributed’ when they are shared with or given to collaborators or other labs on campus or externally. Specimens are no longer available for any future processing or editing once distributed.
Shipment: If a sample is shipped, it remains active and available to view in the system and store events, but is likely located in a different laboratory. That other laboratory can access the specimen in your protocol (given appropriate permissions) to perform and record additional processing on that sample.

In most cases, labs on campus will be ‘distributing’ samples unless the laboratory receiving the samples will also have access to your OpenSpecimen collection protocol to continue to track and process those samples and their derivatives and aliquots. For instance, you can ship samples to the CTRC for processing and long-term storage. In this case, your samples are still active and available for you to see, but their location is elsewhere. And the new location (CTRC) can now perform services on them, like extracting DNA or creating blood separation products, and those events can be tracked within your protocol.

Step 1: Creating a Distribution Protocol (DP)

Information needed to create a DP:

NOTE: To create a DP, your user role must include Create/Edit Distribution Protocol rights.

Who will be receiving the samples and where are they?
1. Principal Investigator (Dr. Robert Smith)
What are the project details?
1. What is Dr. Smith’s IRB (if applicable)?
2. What is Dr. Smith’s project title? (What are they studying that warrants sharing these samples with them?) Does the study fall within the consent statements that the participant signed?
3. Is there an MTA needed and, if so, what is the MTA number?
Who, within you lab, will be responsible for approving this shipment? (PI of your project or a lab manager?) This is an optional field used if you are using a catalog.
Who, within your lab, will be responsible for pulling and shipping the samples?
What information about the specimens will you be sending to Dr. Smith?
1. Specimen type
2. Quantity
3. Concentration
4. Anatomic Site
Do the samples need to be relabeled or de-identified prior to shipping?

Next, create your DP accordingly:

NOTE: Before you can successfully create your DP the ‘Receiving Institute' & 'PI’ MUST be added to OpenSpecimen, as they are required fields in your DP.

If the needed Institute/PI/ coordinators do not already exist (when creating your DP), submit a help request to be added using request form: https://utahctsi.atlassian.net/servicedesk/customer/portal/4/group/23/create/74

Select ‘Distribution Protocols’ from the navigation bar.
Choose ‘Create’.

Complete the fields with the information gathered in the first section.
Required Fields:
1. Title: descriptive of the DP: “Dr. Smith’s specimen request for Project XYZ”
2. Short Title: recognizable acronym or shortened description, “Smith XYZ”
3. Receiving Institute: use ‘University of Utah Health’, even if the samples will be sent elsewhere.
4. Principal Investigator: Requesting PI Name. If the PI is not a user of OpenSpecimen, then use your own PI’s name. (During the distribution of the specimens, there is a comment box that will allow you to record the actual name and address of the recipient of the samples.) If this is an ongoing project, the actual PI name can be added as a ‘Contact’ user by your CP’s administrator or my submitting a ticket to the BMIC. Please include the name, email address, and physical address of the person you wish to be added as a Contact user (the address will be used for the shipping purposes when sending samples). Note that they will not have login permissions, nor will they receive email notifications.
5. Distributing Site(s): Sites allowed to send samples to the above PI. (Note that sometimes a PI will request specimens from multiple projects. So this DP can be used by multiple users and CPs.) Choose the Site name of your laboratory. Note that the Site name must be the Site assigned to the freezers where the specimens are located. This can be found in the main Container overview list.
Optional Fields
1. Receiving Site: if there is a division, dept, or lab associated with the receiving PI, you can optionally specify this. It would have to be added to OpenSpecimen by an Administrator.
2. Coordinators: these are the actual members of the receiving site lab who will be receiving or handling the samples and need to be notified of the shipment and will receive any attachments, like the sample metadata.
3. Ethics ID: This is the IRB number associated with the project belonging to the receiving site.
4. Start and End Dates can be added for DPs that will have shipments sent over time. For instance, some DPs request samples that meet specific criteria to be shipped on a weekly or monthly basis.
5. Label format: this can be specified if samples are being relabeled upon distribution.
6. NOTE: If you wish to utilize either of the below optional features, you must submit a help ticket. If you don’t wish to utilize these optional features, proceed to step (g)
  1. Order Custom Fields (optional): These are your custom fields that can be added to any distribution to collect additional information (fields like ‘shipping address’ or MTA).
  2. Order Report Query (optional): Allows you to specify the data included in a manifest. If you leave this not specified, the order will use the system’s default query to create the fields in the report. To specify your own fields to include, you can create a new query.
    1. Filters:
      1. The name of your collection protocol(s).
      2. Specimen Identifier: ‘Exists’
    2. Columns: Choose any column you want to include in the manifest. Examples include:
      1. PPID (or Identifier if you want it deidentified)
      2. Specimen label or ‘Identifier’
      3. Specimen Type
      4. Initial Quantity
      5. Concentration
      6. Anatomic site
      7. Box location if distributing a large number of samples for which you need to include locations. If using this option, you will need to use ‘Transfer Event': ‘From Container' and 'From Position' and ‘From Row’.
    3. Help ticket request form: https://utahctsi.atlassian.net/servicedesk/customer/portal/4/group/23/create/74
7. Order attachment: this specifies whether the email notifications will include sample data as .csv, .pdf, or both types. If the PI is not a user of OpenSpecimen, then this is not relevant since they will not receive an email.
8. Email notifications: if enabled, all users specified in the above fields will receive a notification of sample shipment once the samples are distributed.

Optional features available to add to a DP:

Consents: If you capture answers to specific consent statements, you can set requirements that samples can only be distributed to a DP based upon a specific answer to a consent statement. For instance, Samples can only be distributed if the participant answered ‘yes’ to ‘samples may be shared with external researchers' or ‘I consent to genetic analysis’.
Requirements: You can set the DP to only allow specimens that meet certain criteria
Services: You can manually assign services associated with a DP that you can subsequently bill for, such as aliquoting and relabelling, add a cost and note if it will be paid with internal or external funding.

Step 2: Distributing Specimens

There are 2 methods that can be used to distribute specimens, expand each method below to review.

Direct Distribution Process:

Select samples to distribute using any specimen screen:
1. Specimen list view
2. Query interface
3. Cart
Choose ‘Distribute’ from the Actions or Specimens dropdown button.
Select the Distribution Protocol from the dropdown list of available distribution protocols.
Add any services to be billed to the person to whom the samples will be sent.
Choose ‘Distribute’.
The specimens will be marked as Distributed and can be found under ‘Orders’.
For auditing purposes, you can find any Orders you’ve created by navigating to ‘Orders’. Alternatively, you can find all orders processed under any specific Distribution Protocol.
Optionally you can choose to save the specimens prior to Distributing them. This will mark the specimens as ‘Reserved’. You can return to the DP and add additional specimens at any time.

Catalog Distribution Process:

To use requests and approvals within a Specimen Catalog, a catalog must first be created for your Biobank. If you need a specimen catalog, submit an OpenSpecimen help ticket: https://utahctsi.atlassian.net/servicedesk/customer/portal/4/group/23/create/74

Create a Distribution Protocol, if one does not yet exist.
Coordinators or the collaborator can request the specimens of interest using the catalog
A specimen request is sent to the Request Manager
The Request Manager will approve, edit, or deny the request.
Upon approval the Request manager can notify the biobank manager who will be pulling and shipping the samples.
The biobank manager will access the request, select the samples, and distribute them (link to section).
The fields in the ‘Order’, will be prefilled, but the manager can fill in the Tracking URL.
The shipment address will be part of the DP.

Distributing Specimens Process