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Oracle® Health Sciences ClearTrial Cloud Service Web Services API User Guide Release 5.0 Part Number E39879-01 |
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# 7 Plan Resource API

The ClearTrial Web Service Plan Resource API returns information about plans stored in the ClearTrial application.

## 7.1 Get Plans

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.

## 7.2 Get Plan

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.

## 7.3 Get Locations

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.

## 7.4 Get Site Information

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

## 7.5 Get Site Approval Schedules

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

## 7.6 Get Subject

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

## 7.7 Get Data

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

## 7.8 Get Subject Enrollment Schedule

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.

## 7.9 Get Treatment

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

## 7.10 Get Monitoring Information

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.

## 7.11 Get Service Provider

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.

## 7.12 Get Monitoring Schedule

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

## 7.13 Get Labor

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

## 7.14 Get Labor Monthly View by Major Task

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

## 7.15 Get Labor Monthly View by Resource

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

## 7.16 Get Costs

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

## 7.17 Get Costs Monthly View

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