1. Omics Modeling 10/25/2011

2. Classes reviewed until last meeting – Person – BiologicEntity – Subject – SubjectIdentifier – Performer – ExperimentalStudy – Experiment – ExperimentalFactor – Activity and subclasses (defined, Planned, Performed Activity) – Experimental Parameters (String Parameter, Numerical Parameter)

3. Classes for discussion today Software Equipment ExperimentalItem Material and relative class

4. Software Definition: A set of coded instructions, which a computer follows in processing data, performing an operation, or solving a logical problem, upon execution of the program.

5. Software Attributes identifier: A unique symbol that establishes identity of the software. – EXAMPLE(S): serial number, product number name: The non-unique textual identifier for the software. version: A form or variant of a type or original; one of a sequence of copies of a software each incorporating new modifications. Notes: 10/25/2011- We may need to revisit the class when we are talking about cloud computing as some of the attributes may not be known (e.g. identifier).

6. Software Attributes typeCode: A coded value specifying the kind of software product. – EXAMPLE(S): data collection, instrument controlling, data analysis, word processing, image processing, productivity, operating system licenseTypeCode: A coded value specifying the kind of license through which the software is available. – EXAMPLE(S):multi-site, open source, single user licenseEffectiveDateRange: The date and time span for when the license for this software is active.

7. Software Attributes buildNumber: A non-unique identifier assigned to identify the compiled version of the software. buildDate: The date on which the particular state of software was produced. licenseKey: A non-unique textual key that certifies that the copy of the program is original. effectiveDateRange: The timeframe within which the software may be used. content: The source or binary file. Notes 10/25/2011 (Michael)- Do we really need licenseKey and content? Grace-Needed to support LIMS. Content would be needed for the code that someone wrote (custom software). Need to revisit. Additional attributes for consideration (not a major issue)- a) URL (where open source or free software is available) to download or purchase

8. Equipment An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. – EXAMPLE(S):tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter Updated Definition: An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, analytical, and/or experimental purposes.

9. Equipment Attributes reprocessedDeviceCode: A coded value specifying whether a device is reconditioned. – EXAMPLE(S): initial use of device, reuse, unknown – Comment (10/25/2011)- The class Equipment is called Device in BRIDG. The class name is modified in LSDAM but not the attribute name. Suggest removing Device from attribute name – Updated Attribute Name: reprocessedCode

10. Equipment Attributes manufactureDate: The date (and time) on which the medical device is made. – Comments (10/25/2011)The device should not be just medical device as the equipment definition is broader. – Updated definition- The date (and time) on which the device is made. validationDate: The date (and time) on which the equipment is validated.

11. ExperimentalItem Definition-Entities used in the execution of an experiment.

12. ExperimentalItem Attributes typeCode: A code representing the role an entity plays in an experiment. – EXAMPLES: reagent, host, sample, data collection tool, analytical tool Notes 10/25/2011 (Grace)-DNA could be a reagent (Herring sperm DNA) and would be different from patient DNA (sample). The role class helps captures this information. - (Joyce) Would need to bring in the entities that are needed for the experiment and are missing from the model. Revisit when we are reviewing Protocol class as these details could be captured in Protocol.

14. Material A class from BRIDG model. Definition: A physical substance. – EXAMPLE(S):drug, device, specimen

15. Material Attribute nameCode: A coded value specifying the non- unique textual identifier for the material. – EXAMPLE(S): aspirin, tobacco, caffeine – NOTE(S): The granularity of the code may vary depending on the specificity of the material. For example, acetaminophen, Tylenol, Tylenol 250 mg gel cap. formCode: A coded value specifying the state and nature of the material. – EXAMPLE(S): solid, liquid, gas, tablet, ointment, gel

16. Material Attribute description: The textual representation of the material. effectiveDateRange: The date and time span for when the material is active.

17. Material Attribute (added by LSDAM) typeCode: Indicates the type of material. – EXAMPLES: protein material, DNA material subTypeCode: The class of a specimen that involves……??? – EXAMPLES:tissue, fluid, cell, molecular Questions – If the class is modified from BRIDG then shouldnt LSDAM to rename the class? – The typecode and subtype code needs to be filipped around i.e. type examples are in subtype and subtype examples are in type?

18. Material and related classes

19. Next Topic Other classes related to Material (e.g. Product, BiologicSpecimen, MaterialRelationship, MaterialIdentifer, MaterialName) Protocol Document (i.e. including Publication) Point of contact Data

20. Slides from last meeting

21. Experimental Parameters Definition- Any factor that defines a system and determines (or limits) its performance. – EXAMPLES: incubation temperature, number of mismatches in a BLAST search, scanning wavelength

23. Experimental Parameters Attributes name: A word or phrase that constitutes the distinctive designation of a parameter. – EXAMPLES: incubation temperature, scanning wavelength typeCode: A term allowing the classification of parameters into categories. – EXAMPLES: centrifuge input, software analysis

24. Experimental Parameters Attributes description: A textual representation of the parameter. – EXAMPLE: temperature setting for centrifugation procedure; analysis start point for GeneMapper 3.7 statusCode-Indicates the condition of use of the parameter at the current time. – EXAMPLES: active, inactive, deprecated

25. NumericParameter (rename to PhysicalQuantityParameter) Definition- The numeric value associated with the experimental parameter. Proposed Definition- The value associated with the experimental parameter. [Reason- as this class captures the numeric value with the optional unit (there is unit associated to the value the value captured can be more that just a number) e.g. temperature = 79.4 Degree Celsius, mass = 4 pounds]

26. NumericParameter Attribute value: The single numeric value assigned to the defined experimental parameter. – EXAMPLES: 2 minutes, 4 degrees Celsius Proposed Definition- value: The single numeric value with its optional unit assigned to the defined experimental parameter. – EXAMPLES: 2 minutes, 4 degrees Celsius

27. NumericParameter Attribute range: The numeric value range assigned to the defined experimental parameter, when a range value of values is called for. – EXAMPLES: 1-4 minutes, 3-8 degrees Celsius Proposed definition range: The numeric value range with its optional unit assigned to the defined experimental parameter, when a range of values is called for. – EXAMPLES: 1-4 minutes, 3-8 degrees Celsius

28. StringParameter Definition- The text value associated with the experimental parameter.

29. StringParameter Attribute value: The single non-numeric value assigned to the defined experimental parameter. Proposed Definition- value: The single textual value assigned to the defined experimental parameter. (Reason- non numeric is not the best way to define String)

30. Association to Protocol and Experiment

31. Association to Software and Equipment

32. StringParameter.value Attributeexample1: GeneMapper 3.7 input parameter Parameter Parameter.dataValueG52100 Parameter.descriptionGeneMapper v3.7 Dye Set G5 for 5 color dye analysis modules. Analysis end point for GeneMapper v3.7 Parameter.nameGM37_DyeSetGM37_Start Parameter.statusCodeactive Parameter.typeCodesoftwareAnalysis Parameter.rangeNA

33. Slides from previous meetings

34. Experimental Study and Experiment

35. Definitions ExperimentStudy- – Current Definition: A detailed examination or analysis designed to discover facts about a system under investigation. Systems may include intact organisms, biologic specimens, natural or synthetic materials, diseases, and pathways. – The definition is application for research, clinical studies and clinical diagnosis that involves molecular testing.

36. Definitions Experiment- – Current Definition: A coordinated set of actions and observations designed to generate data, with the ultimate goal of discovery or hypothesis testing. – Proposed Definition: A coordinated set of actions and observations designed to generate data, with the ultimate goal of either discovery/hypothesis or diagnostic testing.

37. ExperimentalStudy Attributes name: A non-unique identifier by which the experimental study is know or referred. activeDateRange: The timeframe within which the experiment is ongoing. typeCode: Identifies the type of experimental study. EXAMPLES: microarray experiment, model organism experiment designType: A term allowing the classification of the study based on the overall experimental study design. EXAMPLES: time-course design, cross-over design, parallel group design, titration study. Description: A textual explanation of the study, with components, such as objectives or goals. (source: ISA-TAB)

38. Experiment Attribute name: The designation by which an experiment is referenced. activeDateRange: The timeframe within which the experiment is ongoing. typeCode: Identifies the type of experiment. EXAMPLES: microarray experiment, model organism experiment designType: A term allowing the classification of the experiment based on the overall experimental design. EXAMPLES: factorial designs, covariance designs, blocking designs. – Comment (Michael Miller): Do we need the designType in class experiment? It seems duplicate of ExperimentalStudy. Are there examples that show a ExperimentalStudyDesign deciding the design of the Experiment (ExperimentDesign)? – TCGA project is nested at top design type is multi-omics, within that multiple omics experiments-within which multiple centers producing data through runs Description: A textual explanation of the experiment, with components, such as objectives or goals. (source: ISA-TAB)

39. Other Topics Discussed today Activity and subclasses (defined, Planned, Performed Activity) and relationship to ExperimentalStudy and Experiment. ExperimentalFactor – Question (9/29/2011) Michael in Omics call- The Experimenatalfactor has an attribute value as DSET but in the current model we can not associate an experiment to an individual time (we will have all the time associated to the experiment). – Suggestion to LSDAM- Create a separate class called "ExperimentFactorValue". Attributes- 1) value 2) unit. The class will exist between Experimental Factor and Experiment. (Business rule: An experiment has one and only 1 value for each experimental factor). – Would need to delete "Value" attribute from ExperimentalFactor. – Change Request sent to Lisa (9/27/2011) – Need to make change in our model here.

40. Next Topic ExperimentalItem Material and related class