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There are two types of protocols that are supported by OpenSpecimen:
Specimen-centric: for studies in which no patient data is collected or tracked with the sample (biobanking)
Participant-centric: for studies in which participant demographic and disease-specific data is collected, stored, and linked to specimen data.
Planned: Longitudinal studies can be designed to specify details regarding specimen collection for predefined time points.
Unplanned: No defined visits or specimen requirements are set allowing the user to record the collection of any specimen type at any time.
Listed below are key features associated with each Collection Protocol type:
Feature | Specimen-centric | Participant-centric | ||
Planned | Unplanned | |||
Customized storage container design and organization | X | X | X | |
Automatically assign next available storage location | X | X | X | |
Restrict storage location by sample type or study protocols | X | X | X | |
View of storage container contents by specimen ID | X | X | X | |
Maintain traceability of derivatives and aliquots | X | X | X | |
Track specimen processing events | X | X | X | |
Track distributed samples | X | X | X | |
Record samples received back from customers or processing labs | X | X | X | |
Customized Queries, Reports, Invoices | X | X | X | |
Bulk operations | X | X | X | |
Store samples without patient data (Biobanking) | X | |||
Track storage of legacy samples without participant data | X |
| ||
Patient data is collected with specimen |
| X | X | |
Consent statements are tracked and stored |
| X | X | |
Collect multiple specimens over time from the same participant |
| X | X | X |
Collection events and specimen requirements can be set in advance |
| X | ||
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Set predefined visits with expected timing | X | ||
Collect visit-specific patient information | X | ||
Set specimen requirements for each expected visit | X |
General Laboratory Management capabilities of OpenSpecimen
Opportunity for labs to comply with FDA and CLIA regulations for securing specimens
Assign roles to users that will restrict access to PHI and access to specific Protocols
Associate Individual consent statements with each patient
Query users by specific consent events
Attach signed consent pdfs
Upload and extract text from Pathology Reports
Design specimen requirements per visit instructing coordinators regarding collection criteria
Query samples or participants based on any criteria recorded in your Collection Protocol
Create a customized dashboard with your metrics of interest
Create custom Access restrictions to PHI based on user roles
Consent statement tracking for each participant
Upload of Pathology Reports
Collection instructions to study coordinators
Query interface to search for specimens or participants based on your own criteria
Customized dashboard with metrics of interest
Custom forms to record study-specific information
Create derivatives and aliquots (may be defined in CP)
Automatically generate and print labels Label creation according to a predefined schema
Automatic assignment of storage locations to parent specimen, derivatives, and aliquots Restrict
Restricting sample storage by Sample Type type and/or Collection Protocol
Record Processing Events, for example:
Freeze (recording freeze media used)
Fixation (record fixative used)
DNA/RNA extraction, etc.
Reserve Recording of specimen processing events
Reservation of specimens for specific projects or collaborators
Automatically mark specimens as ‘closed’ when exhausted
Distribute and receive specimens for outsourcing or collaborations
What OpenSpecimen Does Not Provide or Offer
A clinical laboratory information management system (LIMS)Reporting functionality for distribution and receiving
Features not supported in OpenSpecimen
Managing large scale laboratory processes. OS is not a general LIMS.
Direct interface with Epic (this option is supported by OS, but the University of Utah does not yet support this option).
If you are interested in an interface for your lab, the laboratory director should complete a Help Desk ticket
Ability to use Utilization of your legacy sample numbering system as the primary participant ID or specimen IDs.
Automatic translation and upload of legacy data
Supports manual upload of bulk data in .csv format
User must map legacy data fields to fields in OpenSpecimen
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If projects are assigned different IRB numbers, use one Collection Protocol per IRB.
Add the same participant to multiple CPs with the click of a button
Restricts study-specific data to the appropriate protocol
Distribute specimens to the specimen-centric Tissue Bank Protocol for storage without compromising PHI
Tissue Banks that store PHI and other patient data will use a Participant-centric protocol.
You must be Be open to change regarding modifications to the your current sample process flow and specimen labeling schema used by your laboratory.
Import of legacy data can be performed maintaining the current sample labeling, but implementing new specimen labeling will likely be necessary.
If custom data fields are required by the Collection Protocol, custom forms can be designed, but this process involves a learning curve to use the advanced features. The BMIC is here to help with thatcan offer support.
A networked label printer is required for label printing.