Introduction to the MIABIS SOP Working Group David van Enckevort June 19, 2017

Definition Scope of this WG is to define a set of common data structures related to describing Standard Operating Procedures (SOPs). The data structures should be concerned with the description of SOPs to make them findable in repositories of SOPs, and as such should include a common set of minimal expected descriptors, but does not define the level of detail required in order to satisfy a given data item at the content level. The model should be consistent with syntax and nomenclature used in the MIABIS 2.0 protocol for describing biorepositories themselves. The model should include sufficient extensibility to ensure that SOPs across disciplines related to biorepositories can be adequately captured. The presence of one or more representatives of the biorepository community that works directly with samples and one or more representative of the SOP harmonization WG will be used to review the proposal in order to ensure appropriateness of fields and ensure extensibility.

Use case: SOP repository in the BBMRI-ERIC Directory BBMRI-ERIC wants to establish a repository of SOPs with assigned persistent identifiers, which allows various BBMRI-ERIC quality-related applications to refer to these identifiers and thus also SOPs themselves.

Use case: SOP Registry in Biospecimen Commons Biospecimen Commons wants to establish a repository of SOPs with assigned persistent identifiers, associated with a searchable database of the repositories themselves, allowing attribution in journals to the specific SOPs used for a given set of samples where the SOPs will remain persistent in their original states.

Potential items ● SOP identifier ● title of the SOP ● purpose of the SOP ● concerned material types ● author ● originating institution ● creation date, modification date ● Link to actual SOP as a reference to a deposited document or text of the SOP ● Information about requirement for special materials/reagents/equipment, not modelling the data itself ● Information about requirements for special safety precautions/personal protective equipment, steps, not modelling the data itself ● Additionally, any data items required in order to properly integrate with MIABIS as a whole should be incorporated.

Relation to other MIABIS modules SOP Image source: DOI: 10.1089/bio.2015.0070

Directory and Self Assessment Tool Provide a persistent link to an SOP to reference the SOP in the Directory and/or Self Assessment Tool Provide high-level insight in the SOPs used to collect, manage and store samples in the biobank

Deliverables Survey SOPs from multiple repositories as available Identify common data elements and generate generalized definitions of the way in which they are most often used Propose classifications for common data elements, including MANDATORY, RECOMMENDED, and OPTIONAL Generate reference examples and additional guidelines for implementation as deemed necessary Deliver a MIABIS module to capture SOP metadata that fulfills the needs of the Use Cases. Ontologized the common data elements in the MIABIS module Paper describing the module to be submitted to an Open Access Journal

Timelines M1 Delivery of survey results (D1) M2 Define common data elements (D2) M3 First version of the module, including classification of the data elements (D3, D5) M5 Ontologize the MIABIS module (D6) M6 Deliver the reference example and guidelines (D4), to submitted as a paper (D7)

Thank you for you attention Questions? miabis-sop-wg@lists.bbmri-eric.eu MIABIS Core 2 paper: DOI: 10.1089/bio.2015.0070