Document: D4D Collection - AI-READI FAIRHub.docx
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[0] Style: normal
Text: {

[1] Style: normal
Text: "id": "https://w3id.org/bridge2ai/data-sheets-schema/collection",

[2] Style: normal
Text: "name": "d4d-collection",

[3] Style: normal
Text: "title": "D4D Collection Subset",

[4] Style: normal
Text: "description": "A LinkML schema subset for capturing how data was collected, including who collected it, over what timeframe, whether consent was gathered, notifications were provided, etc. Based on the “Collection” subset from the full Data Sheets for Datasets (D4D) schema.",

[5] Style: normal
Text: "license": "MIT",

[6] Style: normal
Text: "prefixes": {

[7] Style: normal
Text: "linkml": "https://w3id.org/linkml/"

[8] Style: normal
Text: // Additional prefixes can be added here

[9] Style: normal
Text: },

[10] Style: normal
Text: "subsets": {

[11] Style: normal
Text: "Collection": {

[12] Style: normal
Text: "description": "The \"Collection\" subset focuses on who collected the data, how and when it was collected, whether participants were notified or gave consent, and related ethical considerations."

[13] Style: normal
Text: }

[14] Style: normal
Text: },

[15] Style: normal
Text: "classes": {

[16] Style: normal
Text: "NamedThing": {

[17] Style: normal
Text: "description": "A generic superclass for all identifiable entities."

[18] Style: normal
Text: },

[19] Style: normal
Text: "DatasetProperty": {

[20] Style: normal
Text: "is_a": "NamedThing",

[21] Style: normal
Text: "description": "Represents a single property or aspect of a dataset. Many specialized dataset elements will subclass DatasetProperty."

[22] Style: normal
Text: },

[24] Style: normal
Text: "InstanceAcquisition": {

[25] Style: normal
Text: "is_a": "DatasetProperty",

[26] Style: normal
Text: "description": "Describes how data associated with each instance was acquired (e.g., directly observed, reported by subjects, inferred).",

[27] Style: normal
Text: "in_subset": [

[28] Style: normal
Text: "Collection"

[29] Style: normal
Text: ],

[30] Style: normal
Text: "attributes": {

[31] Style: normal
Text: "description": {

[32] Style: normal
Text: "description": "Free-text description of the acquisition process",

[33] Style: normal
Text: "range": "string",

[34] Style: normal
Text: "multivalued": true,

[35] Style: normal
Text: "examples": [

[36] Style: normal
Text: {

[37] Style: normal
Text: "value": "Data were collected from 1067 participants in the AI-READI T2DM study between July 19, 2023 and July 31, 2024 using multiple modalities (e.g., ECG, retinal imaging, continuous glucose monitors, environment sensors). Some data were entered by participants via REDCap (self-report), and other data were directly captured by clinical or wearable devices."

[38] Style: normal
Text: }

[39] Style: normal
Text: ]

[40] Style: normal
Text: },

[41] Style: normal
Text: "was_directly_observed": {

[42] Style: normal
Text: "description": "Whether the data was directly observed",

[43] Style: normal
Text: "range": "boolean",

[44] Style: normal
Text: "examples": [

[45] Style: normal
Text: {

[46] Style: normal
Text: "value": true,

[47] Style: normal
Text: "description": "Physiological data from ECG, retinal scans, and wearable monitors were directly measured by devices."

[48] Style: normal
Text: }

[49] Style: normal
Text: ]

[50] Style: normal
Text: },

[51] Style: normal
Text: "was_reported_by_subjects": {

[52] Style: normal
Text: "description": "Whether the data was reported directly by the subjects themselves",

[53] Style: normal
Text: "range": "boolean",

[54] Style: normal
Text: "examples": [

[55] Style: normal
Text: {

[56] Style: normal
Text: "value": true,

[57] Style: normal
Text: "description": "Participants entered some information into REDCap forms (e.g., demographic or lifestyle data)."

[58] Style: normal
Text: }

[59] Style: normal
Text: ]

[60] Style: normal
Text: },

[61] Style: normal
Text: "was_inferred_derived": {

[62] Style: normal
Text: "description": "Whether the data was inferred or derived from other data",

[63] Style: normal
Text: "range": "boolean",

[64] Style: normal
Text: "examples": [

[65] Style: normal
Text: {

[66] Style: normal
Text: "value": false,

[67] Style: normal
Text: "description": "No explicit mention of derived data, though some analyses may create secondary variables."

[68] Style: normal
Text: }

[69] Style: normal
Text: ]

[70] Style: normal
Text: },

[71] Style: normal
Text: "was_validated_verified": {

[72] Style: normal
Text: "description": "Whether the data was validated or verified in any way",

[73] Style: normal
Text: "range": "boolean",

[74] Style: normal
Text: "examples": [

[75] Style: normal
Text: {

[76] Style: normal
Text: "value": false,

[77] Style: normal
Text: "description": "The text does not specify formal verification steps beyond standard clinical data collection procedures."

[78] Style: normal
Text: }

[79] Style: normal
Text: ]

[80] Style: normal
Text: }

[81] Style: normal
Text: }

[82] Style: normal
Text: },

[84] Style: normal
Text: "CollectionMechanism": {

[85] Style: normal
Text: "is_a": "DatasetProperty",

[86] Style: normal
Text: "description": "What mechanisms or procedures were used to collect the data (e.g., hardware, manual curation, software APIs)? Also covers how these mechanisms were validated.",

[87] Style: normal
Text: "in_subset": [

[88] Style: normal
Text: "Collection"

[89] Style: normal
Text: ],

[90] Style: normal
Text: "attributes": {

[91] Style: normal
Text: "description": {

[92] Style: normal
Text: "description": "Free-text description of the collection mechanism(s)",

[93] Style: normal
Text: "range": "string",

[94] Style: normal
Text: "multivalued": true,

[95] Style: normal
Text: "examples": [

[96] Style: normal
Text: {

[97] Style: normal
Text: "value": "Data were collected through hardware sensors (ECG machines, environmental monitors, continuous glucose monitors), manual entry into REDCap for clinical data, and standardized imaging devices for retinal scans. All data were organized following the CDS v0.1.1 structure."

[98] Style: normal
Text: }

[99] Style: normal
Text: ]

[100] Style: normal
Text: }

[101] Style: normal
Text: }

[102] Style: normal
Text: },

[104] Style: normal
Text: "DataCollector": {

[105] Style: normal
Text: "is_a": "DatasetProperty",

[106] Style: normal
Text: "description": "Who was involved in the data collection (e.g., students, crowdworkers, contractors), and how they were compensated.",

[107] Style: normal
Text: "in_subset": [

[108] Style: normal
Text: "Collection"

[109] Style: normal
Text: ],

[110] Style: normal
Text: "attributes": {

[111] Style: normal
Text: "description": {

[112] Style: normal
Text: "description": "Free-text details about the data collectors and compensation",

[113] Style: normal
Text: "range": "string",

[114] Style: normal
Text: "multivalued": true,

[115] Style: normal
Text: "examples": [

[116] Style: normal
Text: {

[117] Style: normal
Text: "value": "Data were collected by the AI-READI consortium across multiple clinical sites in the US with researchers funded by an NIH grant (1OT2OD032644). There is no specific mention of crowdsourcing or external contractors."

[118] Style: normal
Text: }

[119] Style: normal
Text: ]

[120] Style: normal
Text: }

[121] Style: normal
Text: }

[122] Style: normal
Text: },

[124] Style: normal
Text: "CollectionTimeframe": {

[125] Style: normal
Text: "is_a": "DatasetProperty",

[126] Style: normal
Text: "description": "Over what timeframe was the data collected, and does this timeframe match the creation timeframe of the underlying data?",

[127] Style: normal
Text: "in_subset": [

[128] Style: normal
Text: "Collection"

[129] Style: normal
Text: ],

[130] Style: normal
Text: "attributes": {

[131] Style: normal
Text: "description": {

[132] Style: normal
Text: "description": "Free-text description of the data collection timeframe",

[133] Style: normal
Text: "range": "string",

[134] Style: normal
Text: "multivalued": true,

[135] Style: normal
Text: "examples": [

[136] Style: normal
Text: {

[137] Style: normal
Text: "value": "Data for this version of the dataset (v2.0.0) were collected between July 19, 2023 and July 31, 2024 from 1067 participants."

[138] Style: normal
Text: }

[139] Style: normal
Text: ]

[140] Style: normal
Text: }

[141] Style: normal
Text: }

[142] Style: normal
Text: },

[144] Style: normal
Text: "DirectCollection": {

[145] Style: normal
Text: "is_a": "DatasetProperty",

[146] Style: normal
Text: "description": "Indicates whether the data was collected directly from the individuals in question or obtained via third parties/other sources.",

[147] Style: normal
Text: "in_subset": [

[148] Style: normal
Text: "Collection"

[149] Style: normal
Text: ],

[150] Style: normal
Text: "attributes": {

[151] Style: normal
Text: "description": {

[152] Style: normal
Text: "description": "Free-text description of data collection source(s)",

[153] Style: normal
Text: "range": "string",

[154] Style: normal
Text: "multivalued": true,

[155] Style: normal
Text: "examples": [

[156] Style: normal
Text: {

[157] Style: normal
Text: "value": "Most data (clinical, wearable, imaging) were collected directly from participants and their devices during study visits or via REDCap forms. No mention of third-party data acquisition."

[158] Style: normal
Text: }

[159] Style: normal
Text: ]

[160] Style: normal
Text: }

[161] Style: normal
Text: }

[162] Style: normal
Text: },

[164] Style: normal
Text: "CollectionNotification": {

[165] Style: normal
Text: "is_a": "DatasetProperty",

[166] Style: normal
Text: "description": "Whether individuals were notified about data collection, and if so, how they were notified.",

[167] Style: normal
Text: "in_subset": [

[168] Style: normal
Text: "Collection"

[169] Style: normal
Text: ],

[170] Style: normal
Text: "attributes": {

[171] Style: normal
Text: "description": {

[172] Style: normal
Text: "description": "Details of the notification method and language",

[173] Style: normal
Text: "range": "string",

[174] Style: normal
Text: "multivalued": true,

[175] Style: normal
Text: "examples": [

[176] Style: normal
Text: {

[177] Style: normal
Text: "value": "Participants were informed of data collection during the study’s consent process, in alignment with standard IRB protocols for clinical research."

[178] Style: normal
Text: }

[179] Style: normal
Text: ]

[180] Style: normal
Text: }

[181] Style: normal
Text: }

[182] Style: normal
Text: },

[184] Style: normal
Text: "CollectionConsent": {

[185] Style: normal
Text: "is_a": "DatasetProperty",

[186] Style: normal
Text: "description": "Whether individuals consented to the collection and use of their data, and how consent was requested/provided.",

[187] Style: normal
Text: "in_subset": [

[188] Style: normal
Text: "Collection"

[189] Style: normal
Text: ],

[190] Style: normal
Text: "attributes": {

[191] Style: normal
Text: "description": {

[192] Style: normal
Text: "description": "Details of the consent process and exact language",

[193] Style: normal
Text: "range": "string",

[194] Style: normal
Text: "multivalued": true,

[195] Style: normal
Text: "examples": [

[196] Style: normal
Text: {

[197] Style: normal
Text: "value": "Informed consent was obtained from all participants prior to data collection. The exact consent language and process are governed by IRB protocols and documented in the study’s protocol (see docs.aireadi.org)."

[198] Style: normal
Text: }

[199] Style: normal
Text: ]

[200] Style: normal
Text: }

[201] Style: normal
Text: }

[202] Style: normal
Text: },

[204] Style: normal
Text: "ConsentRevocation": {

[205] Style: normal
Text: "is_a": "DatasetProperty",

[206] Style: normal
Text: "description": "If consent was obtained, was there a mechanism to revoke that consent in the future?",

[207] Style: normal
Text: "in_subset": [

[208] Style: normal
Text: "Collection"

[209] Style: normal
Text: ],

[210] Style: normal
Text: "attributes": {

[211] Style: normal
Text: "description": {

[212] Style: normal
Text: "description": "Details or evidence of how consent can be revoked",

[213] Style: normal
Text: "range": "string",

[214] Style: normal
Text: "multivalued": true,

[215] Style: normal
Text: "examples": [

[216] Style: normal
Text: {

[217] Style: normal
Text: "value": "Not explicitly stated in the dataset description. Typically, participants can withdraw from NIH-funded studies at any time. Specific revocation procedures would be outlined in the IRB-approved consent form."

[218] Style: normal
Text: }

[219] Style: normal
Text: ]

[220] Style: normal
Text: }

[221] Style: normal
Text: }

[222] Style: normal
Text: },

[224] Style: normal
Text: "EthicalReview": {

[225] Style: normal
Text: "is_a": "DatasetProperty",

[226] Style: normal
Text: "description": "Whether any ethical review or IRB process was conducted, and what the outcomes were.",

[227] Style: normal
Text: "in_subset": [

[228] Style: normal
Text: "Collection"

[229] Style: normal
Text: ],

[230] Style: normal
Text: "attributes": {

[231] Style: normal
Text: "description": {

[232] Style: normal
Text: "description": "Details or references for ethical review, outcomes, or documentation",

[233] Style: normal
Text: "range": "string",

[234] Style: normal
Text: "multivalued": true,

[235] Style: normal
Text: "examples": [

[236] Style: normal
Text: {

[237] Style: normal
Text: "value": "The AI-READI study was conducted under an IRB-approved protocol (NIH-supported). The project explicitly aims to create a roadmap for ethical and equitable research. Outcome: Approval for data collection and sharing with restrictions."

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Text: }

[239] Style: normal
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[240] Style: normal
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[241] Style: normal
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[242] Style: normal
Text: },

[244] Style: normal
Text: "DataProtectionImpact": {

[245] Style: normal
Text: "is_a": "DatasetProperty",

[246] Style: normal
Text: "description": "Whether a data protection impact assessment (or similar) was conducted to evaluate risks to the data subjects, including outcomes or references to documentation.",

[247] Style: normal
Text: "in_subset": [

[248] Style: normal
Text: "Collection"

[249] Style: normal
Text: ],

[250] Style: normal
Text: "attributes": {

[251] Style: normal
Text: "description": {

[252] Style: normal
Text: "description": "Free-text description of the impact assessment",

[253] Style: normal
Text: "range": "string",

[254] Style: normal
Text: "multivalued": true,

[255] Style: normal
Text: "examples": [

[256] Style: normal
Text: {

[257] Style: normal
Text: "value": "All protected health information (PHI) was removed from the dataset, and strong usage restrictions are enforced via a custom license. The text indicates the data is de-identified and only accessible under controlled conditions for T2DM research."

[258] Style: normal
Text: }

[259] Style: normal
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[260] Style: normal
Text: }

[261] Style: normal
Text: }

[262] Style: normal
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[264] Style: normal
Text: }


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Title: Word Document
Author: 
Created: None
Modified: 2025-04-16 17:44:58+00:00
