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Event Types

v1.patient.created

Logged when a patient is created by a referral.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "patientStatus": patientStatus
    "referralReceivedTime": timestamp
}

patientStatus = "potentialCandidate"
              | "preScreening"
              | "firstVisitScheduled"
              | "inScreening"
              | "enrolled"
              | "preScreenFailure"
              | "screenFailure"
              | "discontinued"
              | "archive"
              | "completed"

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "patientStatus": "preScreening",
    "referralReceivedTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • patientStatus: the status of the patient. For v1.patient.created, this will always be potentialCandidate.
  • referralReceivedTime: when the referral was received in StudyTeam

Optional Fields

None

v1.patient.referralAcknowledged

Logged when a patient is acknowledged by the site.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "referralAcknowledgedTime": timestamp
}

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "referralAcknowledgedTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • referralAcknowledgedTime: when the referral was acknowledged by the site

Optional Fields

None

v1.patient.statusChanged

Logged when a patient's status is changed.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "patientStatus": patientStatus
    "statusChangedTime": timestamp
}

patientStatus = "potentialCandidate"
              | "preScreening"
              | "firstVisitScheduled"
              | "inScreening"
              | "enrolled"
              | "preScreenFailure"
              | "screenFailure"
              | "discontinued"
              | "archive"
              | "completed"

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "patientStatus": "preScreening",
    "statusChangedTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • patientStatus: the new status of the patient
  • statusChangedTime: when the patient's status was changed by the site

Optional Fields

None

v1.contactAttempt.created

Logged when a contact attempt is entered into StudyTeam.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "contactAttemptId": string
    "contactAttemptDate": string
    "contactAttemptOutcomes": [contactAttemptOutcome]
}

contactAttemptOutcome = "leftVoicemail"
                      | "noAnswer"
                      | "noLongerInterested"
                      | "phoneScreenFail"
                      | "phoneScreenPass"
                      | "phoneScreenScheduled"
                      | "sentEmail"
                      | "sentText"
                      | "reminderSent"
                      | "wrongNumberOrEmail"

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "contactAttemptId": "ee762d3c-c9b2-4f06-b405-813f283c53a7",
    "contactAttemptDate": "2020-01-01",
    "contactAttemptOutcomes": ["sentEmail", "leftVoicemail"]
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • contactAttemptId: unique StudyTeam ID for the contact attempt
  • contactAttemptDate: the site-provided date when the contact attempt was performed
  • contactAttemptOutcomes: collection of contact outcomes marked by the site

Optional Fields

None

v1.contactAttempt.changed

Logged when a contact attempt is edited in StudyTeam. contactAttemptDate and contactAttemptOutcomes are the only two fields that can be edited; only the fields that were edited and the fields needed to identify the entity are included in the event.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "contactAttemptId": string
    "contactAttemptDate": string | missing
    "contactAttemptOutcomes": [contactAttemptOutcome] | missing
}

contactAttemptOutcome = "leftVoicemail"
                      | "noAnswer"
                      | "noLongerInterested"
                      | "phoneScreenFail"
                      | "phoneScreenPass"
                      | "phoneScreenScheduled"
                      | "sentEmail"
                      | "sentText"
                      | "reminderSent"
                      | "wrongNumberOrEmail"

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "contactAttemptId": "ee762d3c-c9b2-4f06-b405-813f283c53a7",
    "contactAttemptOutcomes": ["sentEmail", "leftVoicemail"]
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • contactAttemptId: unique StudyTeam ID for the contact attempt

Optional Fields

  • contactAttemptOutcomes: collection of contact outcomes marked by the site. Included in the event when outcomes were added or removed in an edit. When included, contains the entire set of new outcomes.
  • contactAttemptDate: the site-provided date when the contact attempt was performed. Included in the event when edited.

v1.contactAttempt.deleted

Logged when a contact attempt is deleted from StudyTeam.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "contactAttemptId": string
}

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "contactAttemptId": "ee762d3c-c9b2-4f06-b405-813f283c53a7"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was referred
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • contactAttemptId: unique StudyTeam ID for the contact attempt

Optional Fields

None

v1.patient.addedTrial

Logged when the patient is assigned to an additional trial.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "patientStatus": patientStatus
    "addedTrialTime": timestamp
}

patientStatus = "potentialCandidate"
              | "preScreening"
              | "firstVisitScheduled"
              | "inScreening"
              | "enrolled"
              | "preScreenFailure"
              | "screenFailure"
              | "discontinued"
              | "archive"
              | "completed"

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "patientStatus": "preScreening",
    "addedTrialTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • patientStatus: the status of the patient.
  • addedTrialTime: when the trial was assigned in StudyTeam

Optional Fields

None

v1.patient.inclusionExclusionCriteriaUpdated

Logged when the patient's inclusion/exclusion criteria is updated. The response contains the current state of
all I/E criteria, and not only the updated criteria.

Schema

"siteId": {
    "type": "string"
},
"trialId": {
    "type": "string"
},
"protocolVersion": {
    "type": "string"
},
"sponsorSiteId": {
    "type": "string"
},
"inclusionExclusionCriteria":
{
  "type": "array",
  "items": {
    "type": "object",
    "properties": {
      "criterionType": {
        "type": {
          "enum": ["inclusion", "exclusion"]
        }
      },
      "passing": {
        "type": {
          "enum": [true, false, null]
        }
      },
      "id": {
        "type": "string"
      },
      "criterionText": {
        "type": "string"
      }
    }
  }
},
"referralSubjectId": {
  "type": "string"
}

Example

{
    "siteId": "cedf4df1-3e66-4989-8fba-303745d16d40",
    "trialId": "d0748312-c2d0-4a91-8769-74c8d9829d03",
    "protocolVersion": "Version 1",
    "sponsorSiteId": "Site 1",
    "inclusionExclusionCriteria": [
        {
            "criterionType": "inclusion",
            "passing": null,
            "id": "1",
            "criterionText": "The subject is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator."
        },
        {
            "criterionType": "inclusion",
            "passing": true,
            "id": "2",
            "criterionText": "The subject has a systolic blood pressure less than 130."
        },
        {
            "criterionType": "exclusion",
            "passing": true,
            "id": "1",
            "criterionText": "The subject has an inability to swallow the study drug tablet."
        },
        {
            "criterionType": "exclusion",
            "passing": true,
            "id": "2",
            "criterionText": "The subject has a history of heart disease."
        }
    ],
    "referralSubjectId": "asdf"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • protocolVersion: the version of the protocol associated with the updated I/E criteria.
  • inclusionExclusionCriteria: an array of objects. each object represents an inclusion or exclusion criterion for the patient, reflecting the current state after the update. passing indicates whether the criterion is passing (i.e. Yes for inclusion or No for exclusion). passing can also be null, indicating that the site has removed their response. criterionText is the text of the inclusion or exclusion criterion. criterionType is either "inclusion" or "exclusion". id is the I/E criterion number, e.g. "1" or "5".

Optional Fields

None

v1.patient.subjectIdUpdated

Logged when the patient's subject ID is updated. This includes when it is removed.

Schema

{
  "subjectId": {
    "type": string
  },
  "siteId": {
    "type": string,
    "format": uuid
  },
  "trialId": {
    "type": string,
    "format": uuid
  },
  "sponsorSiteId": {
    "type": string
  },
  "referralSubjectId": {
    "type": string
  }
  "subjectIdUpdatedTime": {
    "type": timestamp
  }
}

Example

{
    "siteId": "e48aaa06-85ad-484b-9fe7-bd3e95678dcf",
    "subjectId": "zyx",
    "trialId": "2c5e4855-8293-423e-815a-3798d3085295",
    "sponsorSiteId": "1234",
    "subjectIdUpdatedTime": "2023-09-27T15:14:27.745Z",
    "referralSubjectId": "abcde"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • subjectIdUpdatedTime: the timestamp when the subject ID was updated
  • subjectId: the subject ID added to the patient. May be null when the subject ID was removed.

Optional Fields

None

v1.patient.subjectIdAdded (DEPRECATED)

Note: this field was deprecated as of 2023-09-27 and has been replaced by v1.patient.subjectIdUpdated

Logged when the patient's subject id was changed. The events will continue to return the original referralSubjectId.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "subjectIdAddedTime": timestamp
}

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "subjectIdAddedTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • subjectIdAddedTime: when the subject id was added in StudyTeam

Optional Fields

None

v1.patient.subjectIdRemoved (DEPRECATED)

Note: this field was deprecated as of 2023-09-27 and has been replaced by v1.patient.subjectIdUpdated

Logged when the patient's subject id was removed. The events will continue to return the original referralSubjectId.

Schema

{
    "siteId": string
    "trialId": string
    "sponsorSiteId": string
    "referralSubjectId": string
    "subjectIdRemovedTime": timestamp
}

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "subjectIdRemovedTime": "2021-01-15T03:21:35.195Z"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • subjectIdRemovedTime: when the subject id was removed in StudyTeam

Optional Fields

None

v1.patient.plannedScreeningDateUpdated

Logged when the patient's planned screening date is changed.

Schema

{
  "siteId": {
    "type": string,
    "format": uuid
  },
  "trialId": {
    "type": string,
    "format": uuid
  },
  "sponsorSiteId": {
    "type": string
  },
  "referralSubjectId": {
    "type": string
  },
  "plannedScreeningDate": {
    "type": string,
    "format": date
  }
}

Example

{
    "plannedScreeningDate": "2023-09-21",
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • plannedScreeningDate: new date after the planned screening date was updated

Optional Fields

None

v1.patient.patientLogCommentsUpdated

Logged when the patient's log comments is changed.

Schema

{
  "siteId": {
    "type": string,
    "format": uuid
  },
  "trialId": {
    "type": string,
    "format": uuid
  },
  "sponsorSiteId": {
    "type": string
  },
  "referralSubjectId": {
    "type": string
  },
  "patientLogComments": {
    "type": string,
  }
}

Example

{
    "patientLogComments": "An example of patient log comments",
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123"
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • patientLogComments: additional patient comments are added / modified. Can be null when the field is cleared.

Optional Fields

None

v1.patient.reasonsNotScreenedUpdated

Logged when a patient's reasons for not being screened is updated.

Schema

{
  "siteId": {
    "type": string,
    "format": uuid
  },
  "trialId": {
    "type": string,
    "format": uuid
  },
  "sponsorSiteId": {
    "type": string
  },
  "referralSubjectId": {
    "type": string
  },
  "reasonsNotScreened": {
    "type": array,
    "items": {
      "type": string
    }
  }
}

Reasons not screened can include, but is not limited to, the following values

[
    "too-burdensome",
    "too-risky",
    "travel",
    "time-commitment",
    "disinterested",
    "placebo",
    "unreachable",
    "ineligible",
    "other"
]

Example

{
    "siteId": "f3d0ac8e-8005-4d15-af0d-67b0c2ebc759",
    "trialId": "528d1eef-37f6-4f11-965f-5d7fe385ecbb",
    "sponsorSiteId": "1234",
    "referralSubjectId": "abc123",
    "reasonsNotScreened": ["travel","not-screened-reason-001"]
}

Required Fields

  • siteId: unique StudyTeam ID for the clinical research site to which the patient was referred
  • trialId: unique StudyTeam ID for the clinical trial to which the patient was added
  • sponsorSiteId: sponsor-issued identification of the site trial to which the patient was referred
  • referralSubjectId: unique identifier of referred patient
  • reasonsNotScreened: one or more standard or custom reasons a patient was not screened. To remove all reasons not screened, this field can be set to null.

Optional Fields

None

Updated 4 months ago