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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. When a sample is marked as ‘Distributed and Closed’, it no longer is available for any future processing or editing. This is different from a ‘Shipment’ in OpenSpecimen. If a sample is shipped, it remains active and available in the system, but is likely located in a different laboratory. That other laboratory can access the specimen in your protocol (with permissions) and 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. 'Shipments' are specifically used to track the movement of specimens from one location (site) to another. 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.

Prerequisites

Expand to read the what needs to be done prior to beginning the process of creating a DP and distributing specimens

To use requests and approvals, you should have a Specimen Catalog: this will allow you or your collaborators (with permissions) to select the samples that they would like to request. Specimens can be distributed directly from any specimen screen, but the requests and approvals will not be tracked using this method.
Order Custom Fields (optional): If you want to collect additional information (fields like ‘shipping address’ or MTA) you need to create these as a custom form and they should be attached to your DP. <link to KB>.
Order Report Query (optional): To specify the data to include along with the specimens, you can create a query with the columns to include when distributing specimens. (link to KB)
To create a DP, your user role must include Create/Edit Distribution Protocol rights.
The receiving Institute, Principal Investigator, and receiving Site (optional) need to be added to OpenSpecimen by an Administrator.

Step 1: Creating a Distribution Protocol (DP)

Information needed to create a DP:

Click here to view import considerations to create a Distribution Protocol

Who will be receiving the samples and where are they?
1. Principal Investigator (Dr. Robert Smith)
2. Their institute: this is the overarching institute to which the PI belongs (like a University)
3. Their ‘Site’: this is typically the lab or dept name (like Dr. Smith’s Lab or Center for Integrative Science). If you were to ship the samples to the Dr. Smith at the University of Southern California, where within USC would you be addressing the shipment?
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?)
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:

Click here to learn how to create your Distribution Protocol

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 discription, “Smith XYZ”
3. Receiving Institute: (Institute to which requestor belongs; ‘USC’)
4. Principal Investigator: Requesting PI (must belong to the Institute specified above).
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.)
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 teh 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. Order Custom Fields: These are your custom fields that can be added to any distribution.
7. Order Report Query: These are the specific data fields that will be sent to the investigator along with the specimens. If no custom query is defined, the manifest will include the standard fields (what are these?).
8. Order attachment: this specifies whether the email notifications will include sample data as .csv, .pdf, or both types.
9. 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:

Adding consent and specimen dependencies or services 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 aliquotting 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:

Click to view the steps to directly distribute specimens

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 additionall specimens at any time.

Catalog Distribution Process:

Click to view the steps to distribute specimens using a catalog

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.

OS: Specimen distributions