| Oracle® Health Sciences ClearTrial Cloud Service Web Services API User Guide Release 5.5.1 E80538-01 |
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| Oracle® Health Sciences ClearTrial Cloud Service Web Services API User Guide Release 5.5.1 E80538-01 |
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The ClearTrial Web Service Plan Resource API returns information about plans stored in the ClearTrial application.
Gets completed plans accessible to the current user for a given customer ID, ordered by plan and study name. Gets the first 25 complete plans. Using the pagination options, the user can get subsequent pages.
Method: GET
URL: /cleartrial-ws/plans
Table 7-1 Get Plans Query Parameters
| Query Parameters | Description | Accepted Values | Examples |
|---|---|---|---|
|
fetchDeleted |
Filter to include deleted plans or not. Default is true. |
true false |
?fetchDeleted=true ?fetchDeleted=false |
|
page |
For Pagination. What page of results you are on. Default is 1. |
Integer |
?page=1 ?page=5 |
|
dateSinceModified |
Filter to list compounds modified after a specific date and time. |
DD-MMM-YYYY HH:MM:SS (in 24 hr format) DD-MMM-YYYY |
?dateSinceModified= 14-Mar-2016 14:00:00 |
Example: /cleartrial-ws/plans?fetchDeleted=false&page=2&dateSinceModified=14-Mar-2016
Sample output in JSON:
{
"plans": {
"pageNumber": 1,
"pageSize": 25,
"totalPages": 2,
"isLastPage": false,
"plan": [
{
"id": 54170,
"name": "!! 10181-1-cp3",
"code": "test....",
"createdBy": "France, Michelle",
"createdDate": "12-Aug-2013 13:38:46 CDT",
"lastModifiedBy": "Scan, Web",
"lastModifiedDate": "12-Apr-2016 09:33:33 CDT",
"studyId": 27411,
"planState": "Final",
"outsourcingOption": "Combination",
"startDate": "04-Oct-2012 12:00:00 CDT",
"preStudyStartDate": "04-Jul-2012 00:00:00 CDT",
"defaultModelingCurrency": "JPY",
"drugHandlingType": "Room Temperature",
"radioLabeledDrug": true,
"studyDifficulty": "Normal",
"summaryUrl": "/cleartrial-ws/plans/54170/summary",
"locationsUrl": "/cleartrial-ws/plans/54170/locations",
"siteInformationUrl": "/cleartrial-ws/plans/54170/siteInformation",
"siteApprovalScheduleUrl": "/cleartrial-ws/plans/54170/siteApprovalSchedule",
"dataUrl": "/cleartrial-ws/plans/54170/data",
"subjectUrl": "/cleartrial-ws/plans/54170/subject",
"subjectEnrollmentScheduleUrl": "/cleartrial-ws/plans/54170/subjectEnrollmentSchedule",
"treatmentUrl": "/cleartrial-ws/plans/54170/treatment",
"monitoringInformationUrl": "/cleartrial-ws/plans/54170/monitoringInformation",
"monitoringScheduleUrl": "/cleartrial-ws/plans/54170/monitoringSchedule",
"serviceProviderUrl": "/cleartrial-ws/plans/54170/serviceProvider",
"laborUrl": "/cleartrial-ws/plans/54170/labor",
"laborMonthlyByMajorTaskUrl": "/cleartrial-ws/plans/54170/labor?view=monthlyByMajorTask",
"laborMonthlyByResourceUrl": "/cleartrial-ws/plans/54170/labor?view=monthlyByResource",
"costUrl": "/cleartrial-ws/plans/54170/cost",
"costMonthlyUrl": "/cleartrial-ws/plans/54170/cost?view=monthly",
"customAssumptionUrl": "/cleartrial-ws/plans/54170/customAssumption",
"url": "/cleartrial-ws/plans/54170"
},
{
........
},
........
],
"url": "//cleartrial-ws/plans?fetchDeleted=true&dateSinceModified=44-Feb-2016+12:00:00"
}
}
Sample output in XML:
<plans>
<pageNumber>1</pageNumber>
<pageSize>25</pageSize>
<totalPages>2</totalPages>
<isLastPage>false</isLastPage>
<plan>
<id>54170</id>
<name>!! 10181-1-cp3</name>
<code>test....</code>
<createdBy>France, Michelle</createdBy>
<createdDate>12-Aug-2013 13:38:46 CDT</createdDate>
<lastModifiedBy>Scan, Web</lastModifiedBy>
<lastModifiedDate>12-Apr-2016 09:33:33 CDT</lastModifiedDate>
<studyId>27411</studyId>
<planState>Final</planState>
<outsourcingOption>Combination</outsourcingOption>
<startDate>04-Oct-2012 12:00:00 CDT</startDate>
<preStudyStartDate>04-Jul-2012 00:00:00 CDT</preStudyStartDate>
<defaultModelingCurrency>JPY</defaultModelingCurrency>
<drugHandlingType>Room Temperature</drugHandlingType>
<radioLabeledDrug>true</radioLabeledDrug>
<studyDifficulty>Normal</studyDifficulty>
<summaryUrl>/cleartrial-ws/plans/54170/summary</summaryUrl>
<locationsUrl>/cleartrial-ws/plans/54170/locations</locationsUrl>
<siteInformationUrl>/cleartrial-ws/plans/54170/siteInformation</siteInformationUrl>
<siteApprovalScheduleUrl>/cleartrial-ws/plans/54170/siteApprovalSchedule</siteApprovalScheduleUrl>
<dataUrl>/cleartrial-ws/plans/54170/data</dataUrl>
<subjectUrl>/cleartrial-ws/plans/54170/subject</subjectUrl>
<subjectEnrollmentScheduleUrl>/cleartrial-ws/plans/54170/subjectEnrollmentSchedule</subjectEnrollmentScheduleUrl>
<treatmentUrl>/cleartrial-ws/plans/54170/treatment</treatmentUrl>
<monitoringInformationUrl>/cleartrial-ws/plans/54170/monitoringInformation</monitoringInformationUrl>
<monitoringScheduleUrl>/cleartrial-ws/plans/54170/monitoringSchedule</monitoringScheduleUrl>
<serviceProviderUrl>/cleartrial-ws/plans/54170/serviceProvider</serviceProviderUrl>
<laborUrl>/cleartrial-ws/plans/54170/labor</laborUrl>
<laborMonthlyByMajorTaskUrl>/cleartrial-ws/plans/54170/labor?view=monthlyByMajorTask</laborMonthlyByMajorTaskUrl>
<laborMonthlyByResourceUrl>/cleartrial-ws/plans/54170/labor?view=monthlyByResource</laborMonthlyByResourceUrl>
<costUrl>/cleartrial-ws/plans/54170/cost</costUrl>
<costMonthlyUrl>/cleartrial-ws/plans/54170/cost?view=monthly</costMonthlyUrl>
<customAssumptionUrl>/cleartrial-ws/plans/54170/customAssumption</customAssumptionUrl>
<url>/cleartrial-ws/plans/54170</url>
</plan>
<plan>
........
</plan>
........
<url>//cleartrial-ws/plans?fetchDeleted=true&dateSinceModified=44-Feb-2016+12:00:00</url>
</plans>
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. |
In the example above:
'pageNumber': 1, specifies that the current contents belong to page 1.
'pageSize': 25, defines the current page size. In this case, the page has 25 plans.
'totalPages': 2, indicates that there are 2 pages available.
'isLastPage': false, indicates that the current page is not the last page.
Continuing with the example, the user can obtain the next page, by issuing the following request:
/cleartrial-ws/plans?page=2
Sample output of the request:
{
"plans": {
'pageNumber': 2,
"pageSize": 25,
"totalPages": 141,
"isLastPage": false,
"plan": [
{
"id": 16303,
……
……
The user does not have to fetch the pages in sequence. The user can specify any page number in the 'pageNumber' field.
If the user asks for a page that does not exist, the ClearTrial application gets the contents of the last page.
For example, if the user asks for page 142, where there are only 141 pages available, with the request:
/cleartrial-ws/plans?page=142
Sample output:
{
"plans": {
"pageNumber": 141,
"pageSize": 25,
"totalPages": 141,
"isLastPage": true,
"plan": [
{
"id": 16303,
……
……
Because the user requested a page number, 142, that fell outside the total number of pages, the application retrieved the last page, 141.
The isLastPage field is set to true to indicate that the current page is the last available page.
The pageSize field is set to 5, indicating that there are only five plans on the last page.
Obtains the representation for a specific plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}
Sample output in JSON:
{
"plan": {
"id": 18863,
"name": "TP 1234",
"code": "TP 1234",
"description": "TP 1234",
"createdBy": "Administrator, QA",
"createdDate": "15-Jul-2016 11:25:07 CDT",
"lastModifiedBy": "Administrator, QA",
"lastModifiedDate": "15-Jul-2016 11:37:15 CDT",
"studyId": 10601,
"planState": "Draft",
"outsourcingOption": "Combination",
"startDate": "15-Jul-2016 12:00:00 CDT",
"preStudyStartDate": "15-Apr-2016 00:00:00 CDT",
"defaultModelingCurrency": "EUR",
"defaultReportingCurrency": "INR",
"exchangeRateTable": "Test Table",
"exchangeRate": 68.76184052864313,
"drugHandlingType": "Room Temperature",
"radioLabeledDrug": false,
"studyDifficulty": "Normal",
"summaryUrl": "/cleartrial-ws/plans/18863/summary",
"locationsUrl": "/cleartrial-ws/plans/18863/locations",
"siteInformationUrl": "/cleartrial-ws/plans/18863/siteInformation",
"siteApprovalScheduleUrl": "/cleartrial-ws/plans/18863/siteApprovalSchedule",
"dataUrl": "/cleartrial-ws/plans/18863/data",
"subjectUrl": "/cleartrial-ws/plans/18863/subject",
"subjectEnrollmentScheduleUrl": "/cleartrial-ws/plans/18863/subjectEnrollmentSchedule",
"treatmentUrl": "/cleartrial-ws/plans/18863/treatment",
"monitoringInformationUrl": "/cleartrial-ws/plans/18863/monitoringInformation",
"monitoringScheduleUrl": "/cleartrial-ws/plans/18863/monitoringSchedule",
"serviceProviderUrl": "/cleartrial-ws/plans/18863/serviceProvider",
"laborUrl": "/cleartrial-ws/plans/18863/labor",
"laborMonthlyByMajorTaskUrl": "/cleartrial-ws/plans/18863/labor?view=monthlyByMajorTask",
"laborMonthlyByResourceUrl": "/cleartrial-ws/plans/18863/labor?view=monthlyByResource",
"costUrl": "/cleartrial-ws/plans/18863/cost",
"costMonthlyUrl": "/cleartrial-ws/plans/18863/cost?view=monthly",
"customAssumptionUrl": "/cleartrial-ws/plans/18863/customAssumption",
"url": "/cleartrial-ws/plans/18863"
}
}
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 a summary for a specified plan.
Method: GET
URL: /cleartrial-ws/plans/{planID}/summary
Sample output in JSON:
{
"planSummary": {
"planId": 50027,
"studyStartDate": "30-May-2013",
"earliestActivityDate": "30-May-2013",
"latestActivityDate": "09-Oct-2015",
"finalReportDate": "09-Oct-2015",
"studyDuration": 862.0,
"treatmentPeriodDuration": 602.0,
"subjectsPerMonthPerSite": 0.54,
"costPerCompletedSubject": 18996.44749705476,
"feesHoursFtes": {
"total": {
"fees": 58260.47497054761059320782123904791660606861114501953125,
"hours": 7813.6350025646388530731201171875,
"ftes": 3.9069629
},
"taskSummaryGroup": [
{
"id": 1,
"name": "Startup Fees",
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"fees": 19175.4744262695312500,
"hours": 887.616597175598144531250,
"ftes": 1.2336452
},
{
"id": 16303,
"name": "!! TEST SP",
"fees": 303.10033813642198641247205159743316471576690673828125,
"hours": 600.5966637060046195983886718750,
"ftes": 0.83473337
}
]
},
{
"id": 7,
"name": "Other",
"provider": [
{
"id": 16303,
"name": "!! TEST SP",
"fees": 0,
"hours": 0,
"ftes": 0.0
}
]
},
{
"id": 6,
"name": "Medical Writing / Final Report",
"provider": [
{
"id": 16303,
"name": "!! TEST SP",
"fees": 922.5649221995045081712305545806884765625,
"hours": 304.208537042140960693359375,
"ftes": 0.3787054
}
]
},
{
"id": 3,
"name": "Data Management",
"provider": [
{
"id": 16303,
"name": "!! TEST SP",
"fees": 2437.8518534520990215241909027099609375,
"hours": 806.2866775989532470703125,
"ftes": 0.18980163
}
]
},
{
"id": 2,
"name": "Clinical Monitoring, Closeout, and Site Audit Fees",
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"fees": 455.876678466796875,
"hours": 21.6666660308837890625,
"ftes": 0.0057697217
},
{
"id": 16303,
"name": "!! TEST SP",
"fees": 1565.196786008775234222412109375,
"hours": 704.093476258218288421630859375,
"ftes": 0.1874965
}
]
},
{
"id": 5,
"name": "Project Management / Study Oversight",
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"fees": 27241.733464062213897705078125,
"hours": 1115.1467763446271419525146484375,
"ftes": 0.26250795
},
{
"id": 16303,
"name": "!! TEST SP",
"fees": 577.16983725891225986970312078483402729034423828125,
"hours": 2766.4996128380298614501953125,
"ftes": 0.65124
}
]
},
{
"id": 4,
"name": "Biostatistics",
"provider": [
{
"id": 16303,
"name": "!! TEST SP",
"fees": 5581.50666469335556030273437500,
"hours": 607.51999557018280029296875,
"ftes": 0.16306339
}
]
}
]
},
"feesInflation": {
"total": 668.934656583986,
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"inflation": 0.0
},
{
"id": 16303,
"name": "!! TEST SP",
"inflation": 668.934656583986
}
]
},
"costs": {
"total": {
"cost": 131704,
"inflation": 6049.825683116913
},
"cost": [
{
"id": 2,
"name": "Miscellaneous",
"description": "Miscellaneous costs may be marked up by service
providers.",
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"amount": 90,
"inflation": 0.0
},
{
"id": 16303,
"name": "!! TEST SP",
"amount": 2978,
"inflation": 99.13089752197266
}
]
},
{
"id": 1,
"name": "Pass Through",
"description": "Pass through costs that are typically not marked up by
service providers.",
"provider": [
{
"id": 10104,
"name": "Cleartrial Operations",
"amount": 5000,
"inflation": 0.0
},
{
"id": 16303,
"name": "!! TEST SP",
"amount": 123636,
"inflation": 5950.69478559494
}
]
}
]
},
"url": "/cleartrial-ws/plans/50027/summary"
}
}
|
Note: In Phase I Healthy Volunteers studies, the following additional field appears in the Get Summary API: CPU Pass-Through Cost. |
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": 49344,
"locations": [
{
"locationId": 157,
"locationName": "Australia",
"numSites": 300,
"percentSponsorSites": 45.0,
"numSponsorSites": 135,
"percentPreStudySiteVisits": 110.0,
"numPreStudySiteVisits": 330,
"percentPreStudySitePhoneVisits": 0.0,
"numPreStudySitePhoneVisits": 0,
"percentSiteInitVisits": 100.0,
"numSiteInitVisits": 300,
"percentSiteInitPhoneVisits": 0.0,
"numSiteInitPhoneVisits": 0,
"percentSiteCloseoutVisits": 100.0,
"numOnSiteCloseoutVisits": 300,
"percentSiteCloseoutPhoneVisits": 0.0,
"numSiteCloseoutPhoneVisits": 0,
"numGrantPaymentsPerSite": 10,
"percentSitesLocalMonitor": 0.0,
"numSitesLocalMonitor": 0,
"percentSitesOverhead": 0.0,
"numSitesOverhead": 0,
"percentOverhead": 25.0,
"numDrugShips": 1,
"percentSitesAudit": 20.0,
"numSitesAudit": 60,
"pctRegulatoryDocsToCollect": 100.0,
"percentSitesBothIrb": 0.0,
"numSitesBothIrb": 0,
"percentSitesOnlyCentralIrb": 100.0,
"numSitesOnlyCentralIrb": 300,
"percentSitesOnlyLocalIrb": 0.0,
"numSitesOnlyLocalIrb": 0
},
{
"locationId": 101,
"locationName": "Canada",
"numSites": 1212,
"percentSponsorSites": 60.0,
"numSponsorSites": 727,
"percentPreStudySiteVisits": 110.0,
"numPreStudySiteVisits": 1333,
"percentPreStudySitePhoneVisits": 0.0,
"numPreStudySitePhoneVisits": 0,
"percentSiteInitVisits": 100.0,
"numSiteInitVisits": 1212,
"percentSiteInitPhoneVisits": 0.0,
"numSiteInitPhoneVisits": 0,
"percentSiteCloseoutVisits": 100.0,
"numOnSiteCloseoutVisits": 1212,
"percentSiteCloseoutPhoneVisits": 0.0,
"numSiteCloseoutPhoneVisits": 0,
"numGrantPaymentsPerSite": 10,
"percentSitesLocalMonitor": 0.0,
"numSitesLocalMonitor": 0,
"percentSitesOverhead": 0.0,
"numSitesOverhead": 0,
"percentOverhead": 25.0,
"numDrugShips": 1,
"percentSitesAudit": 20.0,
"numSitesAudit": 242,
"pctRegulatoryDocsToCollect": 100.0,
"percentSitesBothIrb": 0.0,
"numSitesBothIrb": 0,
"percentSitesOnlyCentralIrb": 100.0,
"numSitesOnlyCentralIrb": 1212,
"percentSitesOnlyLocalIrb": 0.0,
"numSitesOnlyLocalIrb": 0
}
],
"url": "/cleartrial-ws/plans/49344/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": 49344,
"location": [
{
"locationId": 101,
"locationName": "Canada",
"periods": [
{
"startDate": "08-Feb-2013",
"endDate": "14-Feb-2013",
"numSitesApprovedThisWeek": 0,
"cumulativeNumSitesApproved": 0
},
{
"startDate": "15-Feb-2013",
"endDate": "21-Feb-2013",
"numSitesApprovedThisWeek": 0,
"cumulativeNumSitesApproved": 0
},
{
...
} ] }
],
"url": "/cleartrial-ws/plans/50904/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": 50011,
"enrollmentPeriod": 26,
"indicationEnrollmentType": "Chronic",
"firstSubjectInDate": "31-Dec-2013",
"numCRFPagesPerScreenFailure": 0,
"locations": [
{
"locationId": 157,
"locationName": "Australia",
"numSubjectsToRandomize": 150,
"screenFailureRate": 1.96,
"numSubjectsScreen": 153,
"amountPerScreenFailure": 0.0,
"amountPerScreenFailureCurrency": "USD",
"percentScreenFailuresAllowed": 0.0,
"numScreenFailsAllowed": 0,
"subjectDropRate": 1.0,
"numSubjectsComplete": 148,
"stipendPerScreenFailure": 0.0,
"stipendPerScreenFailureCurrency": "USD"
},
{
...
}
],
"url": "/cleartrial-ws/plans/50011/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": [
{
"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,
"numCpyDataTables": 6, "numPdDataListings": 9, "numCpyFigures": 10,
"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": [
"Randomization",
"Drug Distribution",
"Subject Diary"
],
"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,
"numCpyDataTables": 6, "numCpyDataListings": 9, "numCpyFigures": 10,
"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": [
"Randomization",
"Drug Distribution",
"Subject Diary"
],
"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,
"numCpyPkPdDataTables": 6, "numCpyPkPdDataListings": 9, "numCpyPkPdFigures": 10,
"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": [
"Randomization",
"Drug Distribution",
"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": 50011,
"location": [
{
"locationId": 101,
"locationName": "Canada",
"periods": [
{
"startDate": "31-Dec-2013",
"endDate": "07-Jan-2014",
"numSubjectsEnrolled": 8,
"cumulativeSubjectsEnrolled": 8
},
{
"startDate": "07-Jan-2014",
"endDate": "14-Jan-2014",
"numSubjectsEnrolled": 9,
"cumulativeSubjectsEnrolled": 17
},
{
...
},
{
"locationId": 100,
"locationName": "USA",
"periods" : [
{
},
{
},
{
...
...
}
]
},
{
...
}
],
"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, then the representation is similar to the one that follows.
Sample output in JSON:
{
"treatments": {
"planId": 50411,
"trialDesign": "Parallel",
"electronicSubjectDiary": false,
"endpointStudy": false,
"treatment": [
{
"treatmentId": 1,
"duration": 6,
"durationUnit": "week",
"numSubjectVisits": 5,
"standardTreatment": {
"numCrfPagesPerSubject": 100,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"numCohortEscalationReviews": 4,
"numLabDiagnosticTestsPerSubject": 5,
"monitoringMinutesPerCrfPage": 4.33
},
"treatmentLocations": [
{
"locationId": 157,
"locationName": "Australia",
"grantAmountPerSubject": 5632.0,
"grantAmountPerSubjectCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
{
"locationId": 101,
"locationName": "Canada",
"grantAmountPerSubject": 4536.0,
"grantAmountPerSubjectCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 0,
"numCRFPages": 26,
"monitoringTimeMins": 165.98401,
"pctOfGrant": 20.3125
},
{
"periodNum": 2,
"numCRFPages": 17,
"monitoringTimeMins": 99.845764,
"pctOfGrant": 13.28125
},
{
"periodNum": 3,
"numCRFPages": 18,
"monitoringTimeMins": 105.71904,
"pctOfGrant": 14.0625
},
{
"periodNum": 5,
"numCRFPages": 17,
"monitoringTimeMins": 99.845764,
"pctOfGrant": 13.28125
},
{
"periodNum": 6,
"numCRFPages": 22,
"monitoringTimeMins": 129.21216,
"pctOfGrant": 17.1875
}
]
}
],
"url": "/cleartrial-ws/plans/50411/treatment"
}
}
If the study is an endpoint study, then the output is similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 50411,
"trialDesign": "Parallel",
"electronicSubjectDiary": false,
"endpointStudy": true,
"endpointDetails": {
"weeksFromFsiToEndpoint": 54,
"endpointDate": "11-Dec-2014",
"extendedTreatmentFrequencyInWeeks": 4
},
"treatment": [
{
"treatmentId": 1,
"duration": 6,
"durationUnit": "week",
"numSubjectVisits": 5,
"standardTreatment": {
"numCrfPagesPerSubject": 100,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"numCohortEscalationReviews": 4,
"numLabDiagnosticTestsPerSubject": 5,
"monitoringMinutesPerCrfPage": 4.33
},
"extendedTreatment": {
"numCrfPagesPerExtendedVisit": 7,
"numQOLDataPagesPerExtendedVisit": 0,
"numSubjectDiaryPagesPerExtendedVisit": 0,
"numPharmacoDataPagesPerExtendedVisit": 0
},
"treatmentLocations": [
{
"locationId": 157,
"locationName": "Australia",
"grantAmountPerSubject": 5632.0,
"grantAmountPerSubjectCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
{
"locationId": 101,
"locationName": "Canada",
"grantAmountPerSubject": 4536.0,
"grantAmountPerSubjectCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 0,
"numCRFPages": 26,
"monitoringTimeMins": 165.98401,
"pctOfGrant": 14.130434782608695,
"extendedTreatmentSegment": false
},
{
"periodNum": 2,
"numCRFPages": 17,
"monitoringTimeMins": 99.845764,
"pctOfGrant": 9.239130434782608,
"extendedTreatmentSegment": false
},
{
"periodNum": 3,
"numCRFPages": 18,
"monitoringTimeMins": 105.71904,
"pctOfGrant": 9.782608695652174,
"extendedTreatmentSegment": false
},
{
"periodNum": 5,
"numCRFPages": 17,
"monitoringTimeMins": 99.845764,
"pctOfGrant": 9.239130434782608,
"extendedTreatmentSegment": false
},
{
"periodNum": 6,
"numCRFPages": 22,
"monitoringTimeMins": 129.21216,
"pctOfGrant": 11.956521739130435,
"extendedTreatmentSegment": false
},
{
"periodNum": 10,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 14,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 18,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 22,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 26,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 30,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 34,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 38,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 42,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 46,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 50,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
},
{
"periodNum": 54,
"numCRFPages": 7,
"monitoringTimeMins": 41.11296,
"pctOfGrant": 3.804347826086957,
"extendedTreatmentSegment": true
}
]
}
],
"url": "/cleartrial-ws/plans/50411/treatment"
}
}
If the study is a parallel Phase I Healthy Volunteers study, then the output is similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 51113,
"trialDesign": "Parallel",
"electronicSubjectDiary": false,
"costPerBedNight": 100.0,
"costPerBedNightCurrency": "USD",
"treatment": [
{
"treatmentId": 1,
"duration": 10,
"durationUnit": "day",
"numSubjectVisits": 10,
"numBedNights": 10,
"standardTreatment": {
"numCrfPagesPerSubject": 50,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"monitoringMinutesPerCrfPage": 5.667
},
"treatmentLocations": [
{
"locationId": 103,
"locationName": "Austria",
"procedureCost": 1000.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
{
"locationId": 194,
"locationName": "Puerto Rico",
"procedureCost": 1000.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 0,
"numCRFPages": 11,
"monitoringTimeMins": 49.764,
"pctOfGrant": 22.0
},
{
"periodNum": 1,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 2,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 3,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 5,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 6,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 7,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 8,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 9,
"numCRFPages": 4,
"monitoringTimeMins": 16.648321,
"pctOfGrant": 8.0
},
{
"periodNum": 10,
"numCRFPages": 7,
"monitoringTimeMins": 29.134562,
"pctOfGrant": 14.000000000000002
}
]
}
],
"url": "/cleartrial-ws/plans/51113/treatment"
}
}
If the study is a late-stage crossover study, then the output is similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 50413,
"trialDesign": "Cross-over",
"crossoverDesignType": "Latin Square",
"electronicSubjectDiary": false,
"endpointStudy": false,
"baselineAndWashoutDetails": {
"numCRFPages": 6,
"monitoringTimeMins": 27.456001,
"washoutPeriod": 0,
"washoutPeriodUnit": "week"
},
"treatment": [
{
"treatmentId": 1,
"duration": 250,
"durationUnit": "week",
"numSubjectVisits": 150,
"standardTreatment": {
"numCrfPagesPerSubject": 300,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"numCohortEscalationReviews": 4,
"numLabDiagnosticTestsPerSubject": 5,
"monitoringMinutesPerCrfPage": 4.33
},
"treatmentLocations": [
{
"locationId": 157,
"locationName": "Australia",
"grantAmountPerSubject": 2261.0,
"grantAmountPerSubjectCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 2,
"numCRFPages": 2,
"monitoringTimeMins": 8.32
},
{
"periodNum": 3,
"numCRFPages": 2,
"monitoringTimeMins": 8.32
}, { "periodNum": 100, "numCRFPages": 2, "monitoringTimeMins": 8.32 }, { "periodNum": 247, "numCRFPages": 2, "monitoringTimeMins": 8.32 }, { "periodNum": 248, "numCRFPages": 2, "monitoringTimeMins": 8.32 }, { "periodNum": 250, "numCRFPages": 2, "monitoringTimeMins": 8.32 } ] }, { "treatmentId": 2, "duration": 250, "durationUnit": "week", "numSubjectVisits": 150, "standardTreatment": { "numCrfPagesPerSubject": 300, "numQOLDataPages": 0, "numSubjectDiaryPages": 0, "numPharmacoDataPages": 0.
"monitoringMinutesPerCrfPage": 5.667
}, "treatmentLocations": [ { "locationId": 157, "locationName": "Australia", "grantAmountPerSubject": 2260.0, "grantAmountPerSubjectCurrency": "USD", "stipendPerEnrolledSubject": 0.0, "stipendPerEnrolledSubjectCurrency": "USD" } ], "treatmentSchedule": [ { "periodNum": 2, "numCRFPages": 2, "monitoringTimeMins": 8.32 }, { "periodNum": 3, "numCRFPages": 2, "monitoringTimeMins": 8.32 }, { "periodNum": 250, "numCRFPages": 2, "monitoringTimeMins": 8.32 } ] } ], "url": "/cleartrial-ws/plans/50413/treatment" }}
If the study is a Phase I Healthy Volunteers crossover study, then the output is similar to the representation that follows.
Sample output in JSON:
{
"treatments": {
"planId": 51113,
"trialDesign": "Cross-over",
"crossoverDesignType": "Latin Square",
"electronicSubjectDiary": false,
"costPerBedNight": 100.0,
"costPerBedNightCurrency": "USD",
"baselineAndWashoutDetails": {
"numCRFPages": 77,
"monitoringTimeMins": 348.34802,
"washoutPeriod": 10,
"washoutPeriodUnit": "day",
"washoutPeriodBedNights": 10
},
"treatment": [
{
"treatmentId": 1,
"duration": 10,
"durationUnit": "day",
"numSubjectVisits": 10,
"numBedNights": 10,
"standardTreatment": {
"numCrfPagesPerSubject": 50,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"monitoringMinutesPerCrfPage": 5.667
},
"treatmentLocations": [
{
"locationId": 103,
"locationName": "Austria",
"procedureCost": 500.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
{
"locationId": 194,
"locationName": "Puerto Rico",
"procedureCost": 500.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 1,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 2,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 3,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 4,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 5,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 6,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 7,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 8,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 9,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 10,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
}
]
},
{
"treatmentId": 2,
"duration": 10,
"durationUnit": "day",
"numSubjectVisits": 10,
"numBedNights": 10,
"standardTreatment": {
"numCrfPagesPerSubject": 50,
"numQOLDataPages": 0,
"numSubjectDiaryPages": 0,
"numPharmacoDataPages": 0,
"monitoringMinutesPerCrfPage": 5.667
},
"treatmentLocations": [
{
"locationId": 103,
"locationName": "Austria",
"procedureCost": 500.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
},
{
"locationId": 194,
"locationName": "Puerto Rico",
"procedureCost": 500.0,
"procedureCostCurrency": "USD",
"specialProcedureCost": 0.0,
"specialProcedureCostCurrency": "USD",
"stipendPerEnrolledSubject": 0.0,
"stipendPerEnrolledSubjectCurrency": "USD"
}
],
"treatmentSchedule": [
{
"periodNum": 1,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 2,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 3,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 4,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 5,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 6,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 7,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 8,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 9,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
},
{
"periodNum": 10,
"numCRFPages": 5,
"monitoringTimeMins": 20.810402
}
]
}
],
"url": "/cleartrial-ws/plans/51113/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 output differs subtly based on whether the monitoring is performed globally or at a per-location level. Both variations are shown in the samples below.
Method: GET
URL: /cleartrial-ws/plans/{planID}/monitoringInformation
Sample output in JSON showing monitoring per location and without phone-based monitoring:
{
"monitoringInformation": {
"planId": 50011,
"scheduleManagedPerLocation": true,
"numCRFPages": 42900.0,
"numCRFPagesWithDrops": 42692,
"twentyFourBySevenCoverage":true,
"numMedicalDataListingReviews":4567,
"separateDrugAccountability": false,
"staffPositionForDrugAccountability": "Not Applicable",
"numAdditionalDrugAccountabilityPerSite": 0,
"onSiteMonitoringFrequency": [
{
"locationId": 101,
"locationName": "Canada",
"intervals": [
{
"frequency": 2,
"startDate": "31-Dec-2013",
"endDate": "21-Jan-2014"
},
{
"frequency": 5,
"startDate": "21-Jan-2014",
"endDate": "07-Oct-2014"
}
]
},
{
"locationId": 157,
"locationName": "Australia",
"intervals": [
{
"frequency": 2,
"startDate": "11-Feb-2014",
"endDate": "04-Mar-2014"
},
{
"frequency": 5,
"startDate": "04-Mar-2014",
"endDate": "15-Apr-2014"
},
{
"frequency": 5,
"startDate": "15-Apr-2014",
"endDate": "20-May-2014"
},
{
"frequency": 5,
"startDate": "20-May-2014",
"endDate": "18-Nov-2014"
}
]
}
],
"locationMonitoringDetails": [
{
"locationId": 101,
"locationName": "Canada",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": false,
"monitoringTravelStrategy": "Loop",
"numMonitorTrips": 900
},
{
"locationId": 157,
"locationName": "Australia",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": false,
"monitoringTravelStrategy": "Loop",
"numMonitorTrips": 900
}
],
"url": "/cleartrial-ws/plans/50011/monitoringInformation"
}
}
Sample output in JSON showing monitoring globally and without phone-based monitoring:
{
"monitoringInformation": {
"planId": 50011,
"scheduleManagedPerLocation": false,
"numMonitorTrips": 1800,
"numCRFPages": 42900.0,
"numCRFPagesWithDrops": 42692,
"twentyFourBySevenCoverage":true,
"numMedicalDataListingReviews":4567,
"separateDrugAccountability": false,
"staffPositionForDrugAccountability": "Not Applicable",
"numAdditionalDrugAccountabilityPerSite": 0,
"onSiteMonitoringFrequency": [
{
"locationId": 101,
"locationName": "Canada",
"intervals": [
{
"frequency": 2,
"startDate": "31-Dec-2013",
"endDate": "21-Jan-2014"
},
{
"frequency": 5,
"startDate": "21-Jan-2014",
"endDate": "07-Oct-2014"
}
]
},
{
"locationId": 157,
"locationName": "Australia",
"intervals": [
{
"frequency": 2,
"startDate": "11-Feb-2014",
"endDate": "04-Mar-2014"
},
{
"frequency": 5,
"startDate": "04-Mar-2014",
"endDate": "18-Nov-2014"
}
]
}
],
"locationMonitoringDetails": [
{
"locationId": 101,
"locationName": "Canada",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": false,
"monitoringTravelStrategy": "Loop"
},
{
"locationId": 157,
"locationName": "Australia",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": false,
"monitoringTravelStrategy": "Loop"
}
],
"url": "/cleartrial-ws/plans/50011/monitoringInformation"
}
}
Sample output in JSON showing monitoring globally and with phone-based monitoring:
{
"monitoringInformation": {
"planId": 50011,
"scheduleManagedPerLocation": false,
"numMonitorTrips": 1800,
"numDefaultPhoneBasedMonitoringVisits": 1600,
"numCRFPages": 42900.0,
"numCRFPagesWithDrops": 42692,
"twentyFourBySevenCoverage":true,
"numMedicalDataListingReviews":4567,
"separateDrugAccountability": false,
"staffPositionForDrugAccountability": "Not Applicable",
"numAdditionalDrugAccountabilityPerSite": 0,
"onSiteMonitoringFrequency": [
{
"locationId": 101,
"locationName": "Canada",
"intervals": [
{
"frequency": 2,
"startDate": "31-Dec-2013",
"endDate": "21-Jan-2014"
},
{
"frequency": 5,
"startDate": "21-Jan-2014",
"endDate": "07-Oct-2014"
}
]
},
{
"locationId": 157,
"locationName": "Australia",
"intervals": [
{
"frequency": 2,
"startDate": "11-Feb-2014",
"endDate": "04-Mar-2014"
},
{
"frequency": 5,
"startDate": "04-Mar-2014",
"endDate": "18-Nov-2014"
}
]
}
],
"phoneMonitoringFrequency": [
{
"locationId": 101,
"locationName": "Canada",
"intervals": [
{
"frequency": 5,
"startDate": "31-Dec-2013",
"endDate": "07-Oct-2014"
}
]
},
{
"locationId": 157,
"locationName": "Australia",
"intervals": [
{
"frequency": 5,
"startDate": "11-Feb-2014",
"endDate": "18-Nov-2014"
}
]
}
],
"locationMonitoringDetails": [
{
"locationId": 101,
"locationName": "Canada",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": true,
"monitoringTravelStrategy": "Loop",
"avgHoursPerPhoneBasedVisit": 4.0
},
{
"locationId": 157,
"locationName": "Australia",
"pctCRAFieldTime": 65.0,
"pctMonTimeByCRA": 100.0,
"percentRegionalMonitoring": 0.0,
"pctDataChecked": 100.0,
"timeToReviewPrevData": 7.168,
"avgTravelTime": 5.0,
"useOnSiteMonitoring": true,
"usePhoneBasedMonitoring": true,
"monitoringTravelStrategy": "Loop",
"avgHoursPerPhoneBasedVisit": 4.0
}
],
"url": "/cleartrial-ws/plans/50011/monitoringInformation"
}
}
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":[
{
"periodDate":"23-Sep-2010",
"crfPagesWithDrop":180.0,
"totalTimePerSiteVisit":1.0,
"monitoringDays":0.0
},
{
...
...
},
...
...
}
]
},
{
"locationId":101,
...
},
{
...
...
}
],
"url":"/cleartrial-ws/plans/10802/monitoringSchedule"
}
}
Sub-Resources: None
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,
"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,
"useCompoundInflation":true,
"discountRate":0.0,
"pmUtilizationPrior":160.545,
"pmUtilizationPost":160.545,
"staffUtilization":80.0,
"numAffiliates":0,
"manageCtms":false
},
...
...
],
"url":"/cleartrial-ws/plans/10802/serviceProvider"
}
}
Sample output in XML, including exchange rate data. The exchangeRateDate field is added only if the As-Of option has been selected.
<provider>
<id>10201</id>
<name>QA</name>
<defaultBillingRateLocation>USA</defaultBillingRateLocation>
<effectiveRateYear>2012</effectiveRateYear>
<useCompoundInflation>true</useCompoundInflation>
<discountRate>0.0</discountRate>
<exchangeRates>
<billingRateCurrency>USD</billingRateCurrency>
<exchangeRateDate>07-Mar-2011</exchangeRateDate>
<exchangeRate>
<destinationCurrency>ARS</destinationCurrency>
<value>3.8314499855041495</value>
</exchangeRate>
</exchangeRates>
<lineItemDiscount>0.0</lineItemDiscount>
<lineItemDiscountCurrency>USD</lineItemDiscountCurrency>
<pmUtilizationPrior>0.0</pmUtilizationPrior>
<pmUtilizationPost>0.0</pmUtilizationPost>
<staffUtilization>60.0</staffUtilization>
<numAffiliates>0</numAffiliates>
<manageCtms>false</manageCtms>
</provider>
Sub-Resources: None
Provides details about the service provider for whose scope of work the RFP was created.
Method: GET
URL: /cleartrial-ws/plans/<planID>/serviceProvider/<serviceProviderId>
Sample output in JSON:
{
"serviceProvider": {
"planId": 32610,
"provider": [
{
"name": "2.4.1_CRO",
"defaultBillingRateLocation": "UK",
"effectiveRateYear": 2008,
"useCompoundInflation": false,
"discountRate": 0,
'lineItemDiscount': 99999999.99,
'lineItemDiscountCurrency': USD, "pmUtilizationPrior": 186.89998,
"pmUtilizationPost": 186.89998,
"staffUtilization": 80,
"numAffiliates": 0,
"manageCtms": false
}
],
"url": "/cleartrial-ws/plans/32610/serviceProvider/200" [<= where 200 is service provider id]
}
}
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,
"currency": "USD"
"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,
'billingRateLocationId': 157,
'billingRateLocation': 'Australia',
"unitCost": 0.0,
'InflatedUnitCost': 0.0,
"unitHours": 0.0,
"cost": 0.0,
"hours": 0.0,
'InflatedTotalCost': 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,
'billingRateLocationId': 157,
'billingRateLocation': 'Australia',
"unitCost": 0.0,
'InflatedUnitCost': 0.0,
"unitHours": 0.0,
"cost": 0.0,
"hours": 0.0,
'InflatedTotalCost': 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,
"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",
"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
Obtains a list of all custom assumptions for a specified plan. The custom assumptions are grouped into "studyScopedCustomAssumptions" and "locationScopedCustomAssumptions."
The custom field Label is returned to the custom field endpoint to integrate with an internal system or to be used to generate ad hoc reports using the same field names that users see in the ClearTrial application.
Method: GET
URL: /cleartrial-ws/plans/{planID}/customAssumption
Sample output in JSON:
{
"customAssumptions":
{
"planId": 18608,
"costModel": "5.4",
"customAssumptionModel": 7,
"customAssumptionModelDescription": "Different Label",
"studyScopedCustomAssumptions":
[
{
{
"tab": "Overview",
"name": "customAssumption",
"label": "Label for custom assumption",
"sortOrderRank": 7460,
"workUnitName": "customAssumption",
"dataType": "positive whole number",
"value": 230
}
},
{
"studyScopedCustomAssumption":
{
"tab": "Subject",
"name": "StudyScopedAssumption",
"label": "Study Scoped Assumption",
"sortOrderRank": 3420,
"workUnitName": "StudyScopedAssumption",
"dataType": "positive whole number",
"value": 0
}
},
{
"studyScopedCustomAssumption":
{
"tab": "Data",
"name": "DataStudyScopedAssumption2",
"label": "Data Study Scoped Assumption 2",
"sortOrderRank": 2145,
"workUnitName": "DataStudyScopedAssumption2",
"dataType": "positive whole number",
"value": 0
}
},
{
"studyScopedCustomAssumption":
{
"tab": "Data",
"name": "NewStudyScopedAssumption",
"label": "New Study Scoped Assumption",
"sortOrderRank": 4430,
"workUnitName": "NewStudyScopedAssumption",
"dataType": "positive whole number",
"value": 0
}
},
{
"studyScopedCustomAssumption":
{
"tab": "Data",
"name": "DataTabStudyScopedAssumption",
"label": "Data Tab Study Scoped Assumption",
"sortOrderRank": 7450,
"workUnitName": "DataTabStudyScopedAssumption",
"dataType": "positive whole number",
"value": 0
}
}
],
"locationScopedCustomAssumptions":
[
{
"tab": "Site",
"name": "LocationScopedAssumption",
"label": "Location Scoped Assumption",
"sortOrderRank": 20,
"workUnitName": "LocationScopedAssumption",
"dataType": "positive whole number",
"locations":
[
{
"location":
{
"locationId": 101,
"locationName": "Canada",
"value": 0
}
},
{
"location":
{
"locationId": 158,
"locationName": "New Zealand",
"value": 0
}
}
]
},
{ "tab": "Monitoring", "name": "NewLocationScopedAssumption", "label": "New Location Scoped Assumption", "sortOrderRank": 7440, "workUnitName": "NewLocationScopedAssumption", "dataType": "positive whole number", "locations": [ { "location": { "locationId": 101, "locationName": "Canada", "value": 0 } }, { "location": { "locationId": 158, "locationName": "New Zealand", "value": 0 } } ] } ], "url": "/cleartrial-ws/plans/18608/customAssumption" }}
Sub-Resources: None
