| Oracle® Health Sciences ClearTrial Cloud Service Web Services API User Guide Release 5.0 Part Number E39879-01 |
|
|
View PDF |
| Oracle® Health Sciences ClearTrial Cloud Service Web Services API User Guide Release 5.0 Part Number E39879-01 |
|
|
View PDF |
The ClearTrial Web Service Plan Resource API returns information about plans stored in the ClearTrial application.
Gets all the plans accessible to the current user for a given customer ID.
Method: GET
URL: /cleartrial-ws/plans
Sample output in JSON:
{ "plan": [
{
"id":"10801",
"name":"Baseline Locked Plan",
"code":"test",
"createdBy":"administrator",
"createdDate":"15-Apr-2010",
"lastModifiedBy":"administrator",
"lastModifiedDate":"15-Apr-2010",
"planState":"Draft",
"outsourcingOption":"Combination",
"startDate":"01-Apr-2010",
"preStudyStartDate":"01-Jan-2010",
"defaultModelingCurrency":"USD",
"drugHandlingType":"Room Temperature",
"radioLabeledDrug": false,
"locationsUrl":"/cleartrial-ws/plans/10801/locations",
"siteInformationUrl":"/cleartrial-ws/plans/10801/siteInformation",
"siteApprovalScheduleUrl":"/cleartrial-ws/plans/10801/siteApprovalSchedule",
"dataUrl":"/cleartrial-ws/plans/10801/data",
"subjectUrl":"/cleartrial-ws/plans/10801/subject",
"treatmentUrl":"/cleartrial-ws/plans/10801/treatment",
"monitoringInformationUrl":"/cleartrial-ws/plans/10801/
monitoringInformation",
"monitoringScheduleUrl":"/cleartrial-ws/plans/10801/
monitoringSchedule",
"serviceProviderUrl":"/cleartrial-ws/plans/10801/serviceProvider",
"laborUrl":"/cleartrial-ws/plans/10801/labor",
"laborMonthlyByMajorTaskUrl":"/cleartrial-ws/plans/
labor?view=monthlyByMajorTask":
"laborMonthlyByResourceUrl":"/cleartrial-ws/plans/
labor?view=monthlyByResource",
"costUrl":"/cleartrial-ws/plans/10801/cost",
"costMonthlyUrl":"/cleartrial-ws/plans/cost?view=monthly",
"url":"/cleartrial-ws/plans/10801"
},
{
...
},
{ ...
}
]
}
Sub-Resources: None
Note:
In Phase I Healthy Volunteers studies, the Subject Enrollment Schedule sub-resource URL does not appear in the values returned by the Get Plans API.Obtains the representation for a specific plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}
Sample output in JSON:
{
"plan": {
"id":"10801",
"name":"Baseline Locked Plan",
"code":"test",
"createdBy":"administrator",
"createdDate":"15-Apr-2010",
"lastModifiedBy":"administrator",
"lastModifiedDate":"15-Apr-2010",
"planState":"Draft",
"outsourcingOption":"Combination",
"startDate":"01-Apr-2010",
"preStudyStartDate":"01-Jan-2010",
"defaultModelingCurrency":"USD",
"drugHandlingType":"Room Temperature",
"radioLabeledDrug": false,
"locationsUrl":"/cleartrial-ws/plans/10801/locations",
"siteInformationUrl":"/cleartrial-ws/plans/10801/siteInformation",
"siteApprovalScheduleUrl":"/cleartrial-ws/plans/10801/
siteApprovalSchedule",
"dataUrl":"/cleartrial-ws/plans/10801/data",
"subjectUrl":"/cleartrial-ws/plans/10801/subject",
"treatmentUrl":"/cleartrial-ws/plans/10801/treatment",
"monitoringInformationUrl":"/cleartrial-ws/plans/10801/
monitoringInformation",
"monitoringScheduleUrl":"/cleartrial-ws/plans/10801/monitoringSchedule",
"serviceProviderUrl":"/cleartrial-ws/plans/10801/serviceProvider",
"laborUrl":"/cleartrial-ws/plans/10801/labor",
"laborMonthlyByMajorTaskUrl":"/cleartrial-ws/plans/
labor?view=monthlyByMajorTask":
"laborMonthlyByResourceUrl":"/cleartrial-ws/plans/
labor?view=monthlyByResource",
"costUrl":"/cleartrial-ws/plans/10801/cost",
"costMonthlyUrl":"/cleartrial-ws/plans/cost?view=monthly",
"url":"/cleartrial-ws/plans/10801"
}
}
Sub-Resources:
Locations
Site Information
Site Approval Schedule
Data
Subject
Subject Enrollment Schedule
Treatment
Monitoring Information
Monitoring Schedule
Service Provider
Labor
Labor Monthly by Major Task
Labor Monthly by Resource
Cost
Cost Monthly
Note:
In Phase I Healthy Volunteers studies, the following field does not appear in the Get Plan API: Subject Enrollment Schedule.Obtains the location representation for all locations for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/locations
Sample output in JSON:
{
"planLocations": {
"planId": 10802,
"planLocation": [
{
"locationId": 104,
"locationName":"Belgium",
"numSites": 45,
"numSubjects": 600,
"grantAmountPerSubject": 9500,
"grantAmountCurrency":"USD",
"mohFdaDelayTime": 90
},
{
...
},
{
...
}
],
"url":"/cleartrial-ws/plans/10802/locations"
}
}
Sub-Resources: None.
Obtains the site information representation for each location in a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/siteInformation
Sample output in JSON:
{
"siteInformation":{
"planId":10802,
"locations":[
{
"location":{
"locationId":104,
"locationName":"Belgium",
"numSites":45,
"percentSponsorSites":0.0,
"numSponsorSites":0,
"percentPreStudySiteVisits":110.0,
"numPreStudySiteVisits":50,
"percentPreStudySitePhoneVisits":0.0,
"numPreStudySitePhoneVisits":0,
"percentSiteInitVisits":100.0,
"numSiteInitVisits":45,
"percentSiteInitPhoneVisits":0.0,
"numSiteInitPhoneVisits":0,
"percentSiteCloseoutVisits":100.0,
"numOnSiteCloseoutVisits":45,
"percentSiteCloseoutPhoneVisits":0.0,
"numSiteCloseoutPhoneVisits":0,
"numGrantPaymentsPerSite":9,
"percentSitesLocalMonitor":0.0,
"numSitesLocalMonitor":0,
"percentSitesOverhead":0.0,
"numSitesOverhead":0,
"percentOverhead":25.0,
"numDrugShips":1,
"percentSitesAudit":20.0,
"numSitesAudit":9,
"avgTravelTime":5.0,
"pctRegulatoryDocsToCollect": 100,
"percentSitesBothIrb":0.0,
"numSitesBothIrb":0,
"percentSitesOnlyCentralIrb":100.0,
"numSitesOnlyCentralIrb":45,
"percentSitesOnlyLocalIrb":0.0,
"numSitesOnlyLocalIrb":0
},
{
"locationId":105
...
},
...
}
],
"url":"/cleartrial-ws/plans/10802/siteInformation"
}
}
Sub-Resources: None
Obtains the site approval schedule representation for each location for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/siteApprovalSchedule
Sample output in JSON:
{
"approvalSchedules":{
"planId":10802,
"location":[
{
"locationId":100,
"locationName":"USA",
"periods":[
{
"period":{
"startDate":"01-Apr-2010",
"endDate":"07-Apr-2010",
"numSitesApprovedThisWeek":0,
"cumulativeNumSitesApproved":0
},
"period":{
"startDate":"08-Apr-2010",
"endDate":"14-Apr-2010",
"numSitesApprovedThisWeek":0,
"cumulativeNumSitesApproved":0
},
...
}
]
},
{
"locationId":101,
...
}
...
...
],
"url":"/cleartrial-ws/plans/10802/siteApprovalSchedule"
}
}
Sub-Resources: None
Obtains the subject representation for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/subject
Sample output in JSON:
{
"subject":{
"planId":10802,
"enrollmentPeriod":52,
"indicationEnrollmentType":"Acute",
"firstSubjectInDate":"23-Sep-2010",
"numCRFPagesPerScreenFailure":0,
"locations": [
{
"location": {
"locationId":100,
"locationName":"USA",
"numSubjectsToRandomize":600,
"screenFailureRate":9.090909,
"numSubjectsScreen":660,
"amountPerScreenFailure":0.0,
"amountPerScreenFailureCurrency":"USD",
"percentScreenFailuresAllowed":0.0,
"numScreenFailsAllowed":0,
"subjectDropRate":10.0,
"numSubjectsComplete":540,
"stipendPerScreenFailure": 0,
"stipendPerScreenFailureCurrency":"USD"
}
}
]
"url":"/cleartrial-ws/plans/10802/subject" } }
Get Subject returns a representation for Phase I Healthy Volunteers studies as follows.
Sample output in JSON:
{
"subject": {
"planId": 49308,
"firstSubjectInDate": "22-Apr-2013",
"numCRFPagesPerScreenFailure": 5,
"locations": [
{
"location": {
"locationId": 100,
"locationName": "USA",
"numSubjectsToRandomize": 200,
"percentAlternateSubjects": 10,
"numAlternateSubjects": 20,
"stipendPerAlternateSubject": 0,
"stipendPerAlternateSubjectCurrency": "USD",
"screenFailureRate": 50,
"numSubjectsScreen": 440,
"amountPerScreenFailure": 0,
"amountPerScreenFailureCurrency": "USD",
"percentScreenFailuresAllowed": 2,
"numScreenFailsAllowed": 5,
"subjectDropRate": 5,
"numSubjectsComplete": 190,
"stipendPerScreenFailure": 50,
"stipendPerScreenFailureCurrency": "USD"
}
}
],
"url": "/cleartrial-ws/plans/49308/subject"
}
}
Sub-resources: None
Obtains the data collected representation for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/data
The data represented in the output varies based on the data collection method selected in the plan.
If a non-electronic data collection method is used, such as "Paper (Traditional Monitoring)," then the output is similar to the sample output in JSON as follows:
{
"planData":{
"planId":10802,
"dataCollectionType":"Paper (Traditional Monitoring)",
"queryRate":43.0,
"numUniquePages":15,
"pctDatabaseAudit":10.0,
"numManuscripts":0,
"numDataTransfers":0,
"numInterimAnalyses":0,
"crfPageNCRPly":3,
"numMinsCrfEntry":3.5728002,
"costPerPageToPrint":1.35000002384186,
"costPerPageCurrencyCode":"USD",
"numMinsCrfCoord":4.137056,
"numNewsletters":0,
"numPagesInvestigatorBrochure":125,
"numDataTables":19,
"numDataListings":23,
"numFigures":12,
"numDaysFromLpoToDbLock":14,
"numDaysFromDbLockToStatReport":46,
"numDaysFromDbLockToDraftReport":76,
"numYearsArchive":5,
"numDaysFromDbLockToFinalReport":106,
"icfVideo":false,
"numDataVendors":0,
"numDataImports":0,
"estPctSAE":3.0,
"estNumSAE":56,
"timeToMonitorSAE":4.0,
"pctExpeditedSAE":0.0,
"numExpeditedSAE":0,
"dsmbReportingFrequency":"N/A",
"ivrs": [
null
]
"url":"/cleartrial-ws/plans/10802/data"
}
}
If the data collection method is an electronic data capture method, then the output is similar to the representation that follows. One or more of these fields will be present in the output:
edcMaturityLevel
numEdcScreensPerCrfPage
numOnlineEdcTrainingSessions
These fields will not be present:
crfPageNCRPly
costPerPageToPrint
costPerPageCurrencyCode
Sample output in JSON:
{
"planData": {
"planId": 10802,
"dataCollectionType":"Electronic Data Capture",
"edcMaturityLevel":"Stage 1: Pilot / Single Study",
"queryRate": 30.0,
"numUniquePages": 15,
"numScreensPerCrfPage": 15,
"pctDatabaseAudit": 10.0,
"numManuscripts": 0,
"numDataTransfers": 0,
"numInterimAnalyses": 0,
"numMinsCrfEntry": 0.0,
"numMinsCrfCoord": 1.0,
"numOnlineEdcTrainingSessions": 3,
"numNewsletters": 0,
"numPagesInvestigatorBrochure": 125,
"numDataTables": 19,
"numDataListings": 23,
"numFigures": 12,
"numDaysFromLpoToDbLock": 30,
"numDaysFromDbLockToStatReport": 45,
"numDaysFromDbLockToDraftReport": 73,
"numYearsArchive": 5,
"numDaysFromDbLockToFinalReport": 98,
"icfVideo": false,
"numDataVendors": 0,
"numDataImports": 0,
"estPctSAE":3.0,
"estNumSAE":56,
"timeToMonitorSAE":4.0,
"pctExpeditedSAE":0.0,
"numExpeditedSAE":0,
"dsmbReportingFrequency":"N/A",
"ivrs": [
null
]
"url":"/cleartrial-ws/plans/10802/data"
}
}
Get Data returns a representation for Phase I Healthy Volunteers studies as follows.
Sample output in JSON:
{
"planData": {
"planId": 49308,
"dataCollectionType":"Electronic Data Capture",
"edcMaturityLevel":"Stage 3: Standardization",
"queryRate": 15,
"numUniquePages": 3,
"numScreensPerCrfPage": 3,
"pctDatabaseAudit": 10,
"numManuscripts": 0,
"numDataTransfers": 0,
"numInterimAnalyses": 0,
"numMinsCrfEntry": 0,
"numMinsCrfCoord": 1,
"numOnlineEdcTrainingSessions": 1,
"numNewsletters": 0,
"numPagesInvestigatorBrochure": 125,
"numDataTables": 4,
"numDataListings": 5,
"numFigures": 2,
"numPkPdDataTables": 4,
"numPkPdListings": 5,
"numPkPdFigures": 2,
"numDaysFromLpoToDbLock": 42,
"numDaysFromDbLockToStatReport": 46,
"numDaysFromDbLockToDraftReport": 76,
"numYearsArchive": 10,
"numDaysFromDbLockToFinalReport": 91,
"icfVideo": false,
"numDataVendors": 0,
"numDataImports": 0,
"estPctSAE": 0,
"estNumSAE": 0,
"timeToMonitorSAE": 0,
"pctExpeditedSAE": 0,
"numExpeditedSAE": 0,
"dsmbReportingFrequency":"N/A",
"ivrs": [
{
"ivrsUsage":"Subject Diary"
}
],
"url":"/cleartrial-ws/plans/49308/data"
}
}
Sub-Resources: None
Obtains the subject enrollment schedule representation for each location in a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/subjectEnrollmentSchedule
Sample output in JSON:
{
"enrollmentSchedules":{
"planId":10802,
"location":[
{
"locationId":100,
"locationName":"USA",
"periods":[
{
"period":{
"startDate":"23-Sep-2010",
"endDate":"30-Sep-2010",
"numSubjectsEnrolled":12,
"cumulativeSubjectsEnrolled":12
},
"period":{
"startDate":"30-Sep-2010",
"endDate":"07-Oct-2010",
"numSubjectsEnrolled":11,
"cumulativeSubjectsEnrolled":23
}
"period":{
…
...
}
…
…
}
]
},
{
"locationId":101
…
}
…
],
"url":"/cleartrial-ws/plans/10802/subjectEnrollmentSchedule"
}
}
Sub-Resources: None
Note:
If you issue this call for a Phase I Healthy Volunteers plan, the ClearTrial Web Services API returns a message, 404 Not Found Code, because this resource does not exist for Phase I Healthy Volunteers plans.Obtains the treatment information representation for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/treatment
If the study is not an endpoint study, the representation will be similar to the one that follows.
Sample output in JSON:
{
"treatments": {
"planId": 49309,
"trialDesign": "Parallel",
"electronicSubjectDiary": true,
"endpointStudy": false,
"treatment": [
{
"treatmentId": 1,
"duration": 52,
"durationUnit": "week",
"numSubjectVisits": 20,
"standardTreatment": {
"numCrfPagesPerSubject": 100,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 101,
"locationName": "Canada",
"grantAmountPerSubject": 500.0,
"grantAmountPerSubjectCurrency": "CAD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
"treatmentLocation": {
"locationId": 122,
"locationName": "UK",
"grantAmountPerSubject": 250.0,
"grantAmountPerSubjectCurrency": "GBP",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
...
}
}
],
"treatmentSchedule": [
{
"visit": {
"periodNum": 0,
"numCRFPages": 11,
"monitoringTimeMins": 56.055996,
"pctOfGrant": 11.0
},
"visit": {
"periodNum": 3,
"numCRFPages": 5,
"monitoringTimeMins": 23.441599,
"pctOfGrant": 5.0
},
...
}
]
},
{
"treatmentId": 2,
"duration": 26,
"durationUnit": "week",
"numSubjectVisits": 7,
"standardTreatment": {
"numCrfPagesPerSubject": 10,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 4,
"numPharmacoDataPages": 0
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 101,
"locationName": "Canada",
"grantAmountPerSubject": 500.0,
"grantAmountPerSubjectCurrency": "CAD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
...
}
}
],
"treatmentSchedule": [
{
"visit": {
"periodNum": 0,
"numCRFPages": 5,
"monitoringTimeMins": 15.288,
"pctOfGrant": 50.0
},
...
}
}
]
}
],
"url": "/cleartrial-ws/plans/49309/treatment"
}
}
}
If the study is an endpoint study, then the output will be similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 49334,
"trialDesign":"Parallel",
"electronicSubjectDiary": false,
"endpointStudy": true,
"endpointDetails": {
"weeksFromFsiToEndpoint": 10,
"endpointDate":"14-Jan-2014",
"extendedTreatmentFrequencyInWeeks": 2
},
"treatment": [
{
"treatmentId": 1,
"duration": 6,
"durationUnit":"week",
"numSubjectVisits": 2,
"standardTreatment": {
"numCrfPagesPerSubject": 15,
"numQOLDataPages": 5,
"numSubjectDiaryPages": 5,
"numPharmacoDataPages": 5
},
"extendedTreatment": {
"numCrfPagesPerExtendedVisit": 15,
"numQOLDataPagesPerExtendedVisit": 5,
"numSubjectDiaryPagesPerExtendedVisit": 5,
"numPharmacoDataPagesPerExtendedVisit": 5
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 2,
"locationName":"Western Europe & Japan",
"grantAmountPerSubject": 5000,
"grantAmountPerSubjectCurrency":"USD",
"stipendPerEnrolledSubject": 0,
"stipendPerEnrolledSubjectCurrency":"USD"
},
...
}
],
"treatmentSchedule": [
{
"visit": {
"periodNum": 0,
"numCRFPages": 8,
"monitoringTimeMins": 8.0,
"pctOfGrant": 17.77777777777778,
"extendedTreatmentSegment": false
},
"visit": {
...
} } ] }, { "treatmentId": 2, ...
} } ] } ], "url": "/cleartrial-ws/plans/49334/treatment" }}
If the study is a parallel Phase I Healthy Volunteers study, then the output will be similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 49308,
"trialDesign": "Parallel",
"electronicSubjectDiary": true,
"costPerBedNight": 250.0,
"costPerBedNightCurrency": "USD",
"treatment": [
{
"treatmentId": 1,
"duration": 60,
"durationUnit": "day",
"numSubjectVisits": 60,
"numBedNights": 5,
"standardTreatment": {
"numCrfPagesPerSubject": 60,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 2,
"numPharmacoDataPages": 0
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 101,
"locationName": "Canada",
"procedureCost": 250.0,
"procedureCostCurrency": "CAD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
...
} } ], "treatmentSchedule": [ { "visit": { "periodNum": 0, "numCRFPages": 7, "monitoringTimeMins": 30.6124, "pctOfGrant": 11.666666666666666 }, ...
}, "visit": {
...
} } ] } ], "url": "/cleartrial-ws/plans/49308/treatment" }}
If the study is a late-stage crossover study, then the ouput will be similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 49309,
"trialDesign": "Cross-over",
"crossoverDesignType": "Latin Square",
"electronicSubjectDiary": true,
"endpointStudy": false,
"baselineAndWashoutDetails": {
"numCRFPages": 10,
"monitoringTimeMins": 50.96,
"washoutPeriod": 0,
"washoutPeriodUnit": "week",
"washoutSchedule": [
null
]
},
"treatment": [
{
"treatmentId": 1,
"duration": 52,
"durationUnit": "week",
"numSubjectVisits": 20,
"standardTreatment": {
"numCrfPagesPerSubject": 100,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 101,
"locationName": "Canada",
"grantAmountPerSubject": 370.0,
"grantAmountPerSubjectCurrency": "CAD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
...
} } ], "treatmentSchedule": [ { "visit": { "periodNum": 3, "numCRFPages": 5, "monitoringTimeMins": 23.441599 },
...
} } ] }, { "treatmentId": 2, "duration": 26, "durationUnit": "week", "numSubjectVisits": 7, "standardTreatment": { "numCrfPagesPerSubject": 10, "numQOLDataPages": 0, "numSubjectDiaryPages": 4, "numPharmacoDataPages": 0 }, "treatmentLocations": [ { "treatmentLocation": { "locationId": 101, "locationName": "Canada", "grantAmountPerSubject": 130.0, "grantAmountPerSubjectCurrency": "CAD", "stipendPerEnrolledSubject": 0.0, "stipendPerEnrolledSubjectCurrency": "USD" },
...
} } ], "treatmentSchedule": [ { "visit": { "periodNum": 4, "numCRFPages": 1, "monitoringTimeMins": 2.8129919 },
...
} } ] } ], "url": "/cleartrial-ws/plans/49309/treatment" }}
If the study is a Phase I Healthy Volunteers crossover study, then the output will be similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 49308,
"trialDesign": "Cross-over",
"crossoverDesignType": "Latin Square",
"electronicSubjectDiary": true,
"costPerBedNight": 250.0,
"costPerBedNightCurrency": "USD",
"baselineAndWashoutDetails": {
"numCRFPages": 10,
"monitoringTimeMins": 45.239998,
"washoutPeriod": 5,
"washoutPeriodUnit": "day",
"washoutPeriodBedNights": 5,
"washoutSchedule": [
null
]
},
"treatment": [
{
"treatmentId": 1,
"duration": 60,
"durationUnit": "day",
"numSubjectVisits": 60,
"numBedNights": 5,
"standardTreatment": {
"numCrfPagesPerSubject": 60,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 2,
"numPharmacoDataPages": 0
},
"treatmentLocations": [
{
"treatmentLocation": {
"locationId": 101,
"locationName": "Canada",
"procedureCost": 238.0,
"procedureCostCurrency": "CAD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
...
}
}
],
"treatmentSchedule": [
{
"visit": {
"periodNum": 1,
"numCRFPages": 1,
"monitoringTimeMins": 4.16208
},
"visit": {
"periodNum": 2,
"numCRFPages": 1,
"monitoringTimeMins": 4.16208
},
"visit": {
"periodNum": 3,
"numCRFPages": 1,
"monitoringTimeMins": 4.16208
}
}
]
}
],
"url": "/cleartrial-ws/plans/49308/treatment"
}
}
Sub-Resources: None
Obtains the monitoring information representation for a specified plan. This includes the on-site and phone-based monitoring frequency information.
The data in the output varies based on the type of monitoring selected in the plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/monitoringInformation
Sample output in JSON showing phone-based monitoring:
{
"monitoringInformation":{
"planId":10802,
"useOnSiteMonitoring":true,
"usePhoneBasedMonitoring":true,
"monitoringTravelStrategy":"Loop",
"numMonitorTrips":1903,
"numPhoneBasedMonitoringVisits":1903,
"avgHoursPerPhoneBasedVisit":4.0,
"pctCRAFieldTime":65.0,
"pctMonTimeByCRA":100.0,
"percentRegionalMonitoring":0.0,
"pctDataChecked": 100,
"timeToReviewPrevData":9.06752,
"numCRFPages":241150.0,
"numCRFPagesWithDrops":228721,
"medicalMonitoringFtes":0.25308245,
"dsmbReportingFrequency":"N/A",
"separateDrugAccountability":false,
"staffPositionForDrugAccountability":"Not Applicable",
"numAdditionalDrugAccountabilityPerSite":0,
"onSiteMonitoringFrequency":[
{
"location":{
"locationId":100,
"locationName":"USA",
"intervals":[
{
"interval":{
"frequency":7,
"startDate":"23-Sep-2010",
"endDate":"22-Mar-2012"
},
{
...
...
},
...
...
}
]
},
"location":{
...
...
},
...
...
}
],
"phoneMonitoringFrequency":[
{
"location":{
"locationId":100,
"locationName":"USA",
"intervals":[
{
"interval":{
"frequency":7,
"startDate":"23-Sep-2010",
"endDate":"22-Mar-2012"
},
{
...
...
},
...
...
}
]
},
"location":{
...
...
},
...
...
}
],
"url":"/cleartrial-ws/plans/10802/monitoringInformation"
}
}
Sub-Resources: None
If the study plan does not include phone-based monitoring, the following fields are missing from the representation:
numPhoneBasedMonitoringVisits
avgHoursPerPhoneBasedVisit
phoneMonitoringFrequency
Sample output in JSON without phone-based monitoring:
{
"monitoringInformation": {
"planId": 10802,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": false,
"monitoringTravelStrategy":"Loop",
"numMonitorTrips": 832,
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100,
"timeToReviewPrevData": 3.4003203,
"numCRFPages": 75847.0,
"numCRFPagesWithDrops": 74014,
"medicalMonitoringFtes": 0.25308245,
"separateDrugAccountability": false,
"staffPositionForDrugAccountability":"Not Applicable",
"numAdditionalDrugAccountabilityPerSite": 0,
"onSiteMonitoringFrequency": [
{
"location": {
"locationId": 100,
"locationName":"USA",
"intervals": [
{
"interval": {
"frequency": 7,
"startDate":"23-Sep-2010",
"endDate":"12-May-2011"
}
}
]
},
"location": {
"locationId": 123,
"locationName":"Japan",
"intervals": [
{
"interval": {
"frequency": 7,
"startDate":"07-Oct-2010",
"endDate":"12-May-2011"
}
}
]
},
"location": {
"locationId": 104,
"locationName":"Belgium",
"intervals": [
{
"interval": {
"frequency": 7,
"startDate":"23-Sep-2010",
"endDate":"12-May-2011"
}
}
]
}
}
],
"url":"/cleartrial-ws/plans/10802/monitoringInformation"
}
}
Sub-Resources: None
Note:
If this is a Phase I Healthy Volunteers study plan, the monitoring periods are a day apart.Obtains the service providers that are used in the specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/serviceProvider
Sample output in JSON:
{
"serviceProvider":{
"planId":10802,
"provider":[
{
"name":"QA",
"defaultBillingRateLocation":"USA",
"effectiveRateYear":2010,
"inflationRateYear2":3.0,
"inflationRateSubsequent":5.0,
"useCompoundInflation":true,
"discountRate":0.0,
"pmUtilizationPrior":0.0,
"pmUtilizationPost":0.0,
"staffUtilization":60.0,
"numAffiliates":0,
"manageCtms":false
},
{
"name":"Premium CRO",
"defaultBillingRateLocation":"USA",
"effectiveRateYear":2010,
"inflationRateYear2":3.0,
"inflationRateSubsequent":5.0,
"useCompoundInflation":true,
"discountRate":0.0,
"pmUtilizationPrior":160.545,
"pmUtilizationPost":160.545,
"staffUtilization":80.0,
"numAffiliates":0,
"manageCtms":false
},
...
...
],
"url":"/cleartrial-ws/plans/10802/serviceProvider"
}
}
Sub-Resources: None.
Obtains the monitoring schedule representation for each location in a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/monitoringSchedule
Sample output in JSON:
{
"monitoringSchedule":{
"planId":10802,
"location":[
{
"locationId":100,
"locationName":"USA",
"periods":[
{
"period":{
"periodDate":"23-Sep-2010",
"crfPagesWithDrop":180.0,
"totalTimePerSiteVisit":1.0,
"monitoringDays":0.0
},
"period":{
...
...
},
...
...
}
]
},
{
"locationId":101,
...
},
...
...
],
"url":"/cleartrial-ws/plans/10802/monitoringSchedule"
}
}
Sub-Resources: None
Shows the breakdown of labor by major task, task, location, and resources.
Method: GET
URL: /cleartrial-ws/plans/{planID}/labor
Sample output in JSON:
{
"planLabor": {
"planId": 10802,
"majorTask": [
{
"id": 2,
"name":"Project Initiated",
"unitOfMeasure":"Study",
"task": [
{
"id": 2,
"name":"Develop scope of work, timeline, work assignments",
"location": [
{
"locationId": 0,
"locationName":"All Locations",
"resource": [
{
"id": 1,
"name":"CR01 - Clinical Research Associate",
"code":"CR01",
"serviceProviderId": 10201,
"serviceProviderName":"QA",
"startDate":"01-Apr-2010",
"endDate":"23-Sep-2010",
"billingRate": 0.0,
"unitCost": 0.0,
"unitHours": 0.0,
"cost": 0.0,
"hours": 0.0,
"numUnits": 1.0
},
{
"id": 2,
"name":"CR02 - Senior Clinical Research Associate",
...
},
...
]
}
]
}
]
},
{
"id": 31,
"name":"Study Setup Per-Location",
"unitOfMeasure":"Location(s)",
"task": [
{
"id": 303,
"name":"Translate Investigator Brochure",
"location": [
{
"locationId": 100,
"locationName":"USA",
"resource": [
{
"id": 1,
"name":"CR01 - Clinical Research Associate",
"code":"CR01",
"serviceProviderId": 10201,
"serviceProviderName":"QA",
"startDate":"01-Apr-2010",
"endDate":"23-Sep-2010",
"billingRate": 0.0,
"unitCost": 0.0,
"unitHours": 0.0,
"cost": 0.0,
"hours": 0.0,
"numUnits": 0.0
},
{
"id": 2,
"name":"CR02 - Senior Clinical Research Associate",
...
...
},
...
...
]
},
{
"locationId": 123,
"locationName":"Japan",
...
...
},
...
...
]
}
],
}
],
"url":"/cleartrial-ws/plans/10802/labor"
}
}
Sub-Resources: None
Shows the monthly cost, inflation, and hours breakdown of labor by provider, location, department, general ledger code, and major task.
Method: GET
URL: /cleartrial-ws/plans/{planID}/labor?view=monthlyByMajorTask
Sample output in JSON:
{
"planLaborMonthlyView": {
"planId": 10802,
"currency":"USD",
"provider": [
{
"id": 251,
"name":"Premium CRO",
"location": [
{
"id": 0,
"name":"All Locations",
"department": [
{
"id": 2,
"name":"Clinical Operations",
"generalLedgerCode": [
{
"id": 21,
"name":"Professional Fees",
"majorTask": [
{
"id": 2,
"name":"Project Initiated",
"unitOfMeasure":"Study",
"monthlyCost": [
{
"year": 2010,
"month": 4,
"cost": 12640.567335728245,
"inflation": 0.0,
"hours": 51.39730903080536
},
{
"year": 2010,
"month": 5,
"cost": 13061.919580252521,
"inflation": 0.0,
"hours": 53.110552665165535
},
...
...
]
},
{
"id": 32,
"name":"Study Setup",
"unitOfMeasure":"Study",
"monthlyCost": [
...
...
]
},
...
...
]
}
{
"id": 6,
"name":"Dues & Subscription",
"majorTask": [
{
"id": 2,
"name":"Project Initiated",
"unitOfMeasure":"Study",
"monthlyCost": [
{
"year": 2010,
"month": 4,
"cost": 22640.567335728245,
"inflation": 0.0,
"hours": 61.39730903080536
},
{
"year": 2010,
"month": 5,
"cost": 13061.919580252521,
"inflation": 0.0,
"hours": 53.110552665165535
},
...
...
]
},
{
"id": 32,
"name":"Study Setup",
"unitOfMeasure":"Study",
"monthlyCost": [
...
...
]
},
...
...
]
}
...
...
]
},
{
"id": 3,
"name":"Data Management",
...
...
},
...
...
},
{
"id": 100,
"name":"USA",
...
...
},
...
...
},
{
"id": 10201,
"name":"QA",
...
...
}
…
...
],
"url":"/cleartrial-ws/plans/10802/labor?view=monthlyByMajorTask"
}
}
Sub-Resources: None
Shows the monthly hours breakdown of labor by provider, location, department, general ledger code, resource, and major task.
Method: GET
URL: /cleartrial-ws/plans/{planID}/labor?view=monthlyByResource
Sample output in JSON:
{
"planResourcesMonthlyView": {
"planId": 10802,
"provider": [
{
"id": 251,
"name":"Premium CRO",
"location": [
{
"id": 0,
"name":"All Locations",
"department": [
{
"id": 2,
"name":"Clinical Operations",
"generalLedgerCode": [
{
"id": 21,
"name":"Professional Fees",
"resource": [
{
"id": 1,
"name":"Clinical Research Associate",
"code":"CR01",
"majorTask": [
{
"id": 2,
"name":"Project Initiated",
"unitOfMeasure":"Study",
"monthlyCost": [
{
"year": 2010,
"month": 4,
"hours": 7.187143380301344
},
{
"year": 2010,
"month": 5,
"hours": 7.42671482631139
},
...
...
},
{
"id": 32,
"name":"Study Setup",
"unitOfMeasure":"Study",
...
...
},
...
...
]
},
{
"id": 2,
"name":"Senior Clinical Research Associate",
"code":"CR02",
...
...
},
]
},
{
"id": 6,
"name":"Dues & Subscription",
...
...
}
},
{
"id": 3,
"name":"Data Management",
...
...
},
...
...
]
},
{
"id": 100,
"name":"USA",
...
...
},
...
...
]
},
{
"id": 10201,
"name":"QA",
...
...
}
...
...
],
"url":"/cleartrial-ws/plans/10802/labor?view=monthlyByResource"
}
}
Sub-Resources: None
Shows the calculated costs for a plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/cost
Sample output in JSON:
{
"costs": {
"planId": 10802,
"cost": [
{
"id": 1,
"name":"Advertising (additional)",
"type":"Miscellaneous",
"department":"Clinical Operations",
"generalLedgerCode":"Advertising and Promotion",
"location": [
{
"id": 0,
"name":"All Locations",
"serviceProvider":"QA",
"startDate":"01-Apr-2010",
"endDate":"20-Jul-2012",
"amount": {
"currency":"USD",
"calculatedAmount": 0,
"adjustmentAmount": 0,
"inflationAmount": 0.0,
"totalAmount": 0
}
}
]
},
{
"id": 38,
"name":"Clinical Trial Insurance",
"type":"Pass Through",
"department":"Safety",
"generalLedgerCode":"Insurance",
"location": [
{
"id": 104,
"name":"Belgium",
"serviceProvider":"Premium CRO",
"startDate":"01-Apr-2010",
"endDate":"20-Oct-2010",
"amount": {
"currency":"USD",
"calculatedAmount": 28000,
"adjustmentAmount": 0,
"inflationAmount": 0.0,
"totalAmount": 28000
}
},
{
"id": 123,
"name":"Japan",
...
},
…
...
]
},
…
...
],
"url":"/cleartrial-ws/plans/10802/costs"
}
}
Sub-Resources: None
Shows the monthly calculated costs and inflation breakdown for a plan by provider, location, department, general ledger code, and cost.
Method: GET
URL: /cleartrial-ws/plans/{planID}/cost?view=monthly
Sample output in JSON:
{
"costsMonthlyView": {
"planId": 10802,
"currency":"USD",
"provider": [
{
"id": 251,
"name":"Premium CRO",
"location": [
{
"id": 0,
"name":"All Locations",
"department": [
{
"code":"CR",
"name":"Clinical Operations",
"generalLedgerCode": [
{
"code":"2800",
"name":"Outside Services",
"cost": [
{
"id": 39,
"name":"EDC Setup",
"type":"Pass Through",
"monthlyCost": [
{
"year": 2010,
"month": 8,
"cost": 2666.6666666666665,
"inflation": 0.0
},
{
"year": 2010,
"month": 9,
"cost": 7333.333333333333,
"inflation": 0.0
}
...
...
]
},
{
"id": 40,
"name":"EDC Licensing",
"type":"Pass Through",
...
...
},
...
...
]
},
{
"code":"3600",
"name":"Travel Expense",
...
...
}
...
...
]
},
{
"code":"DS",
"name":"Safety",
}
...
...
]
},
{
"id": 104,
"name":"Belgium",
...
...
},
...
...
]
},
{
"id": 10201,
"name":"QA",
...
...
},
...
...
],
"url":"/cleartrial-ws/plans/10802/cost?view=monthly"
}
}
Sub-Resources: None
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