Study Site Dataset

Track updates in site configuration for sites in a study and across studies.

You can use the Study Site dataset to analyze and visualize study-specific site configuration details and selected site property history across studies.

Modes

Available in all 3 modes: Testing, Training, and Production

What type of data can I include in a custom report or visualization on study site?

The dataset includes study-specific site information, such as study versions, SDV settings, supply settings, and screening limits, helping you understand how a site is configured within a study.

For selected site configuration settings, audit history is available through the PROPERTY_NAME and PROPERTY_VALUE fields. This allows you to track changes to items such as study version, site status, screening and randomization limits, and subject management settings.

Other site details, such as address, investigator, country, SDV settings, and supply settings, display the latest available values only.

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Browse description of data elements included in this dataset:

Note:

Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

• Study Design folder
  This table describes the data elements included in the Study Design folder
• Study Site folder
  This table describes the data elements included in the Study Site folder.
• Organization folder
  This table describes the data elements included in the Organization folder.
• Address folder
  This table describes the data elements included in the Address folder.
• Country folder
  This table describes the data elements included in the Country folder.
• Investigator folder
  This table describes the data elements included in the Investigator folder.
• SDV Setting folder
  This table describes the data elements included in the SDV Setting folder
• Reference folder
  This table describes the data elements included in the Reference folder
• Supply Setting folder
  This table describes the data elements included in the Supply folder
• Audit folder
  This table describes the data elements included in the Audit folder

Study Design folder

This table describes the data elements included in the Study Design folder

Table 3-45 Data elements in the Study Design folder

Data elements	Description
STUDY_MODE	Indicates the study mode used in the referencing data in a custom report. Values can be Testing Training Active
STUDY_ID_NAME	The study ID as specified when the study was created. The study ID typically includes the protocol acronym or protocol number and must be unique within a tenant. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.
STUDY_TITLE	The Study Title as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.
STUDY_REFNAME	Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed.
STUDY_PHASE	The study phase as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The study phase is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.studyPhase codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
THERAPEUTIC_AREA	Indicates the therapeutic area as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The therapeutic area is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.therapeuticArea codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
BLINDING_TYPE	Indicates the blinding type of the study (whether the study is open-label or blinded) as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The blinding type is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.openLableBlinded codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
STUDY_VERSION	Indicates the study version of the referencing data in a custom report. The study version is associated to a subject and corresponds to that on which a subject was added to the study. This value does not change for a subject, regardless of the creation of new study versions for a given mode.

Study Site folder

This table describes the data elements included in the Study Site folder.

Table 3-46 Data elements in the Study Site folder

Data element	Description
PROPERTY_NAME	Name of the property to which the site is associated to.
PROPERTY_VALUE	Value of the property to which the site is associated to.
SITE_ACTIVE_MAX_DATE	Indicates when the site was most recently set to Active.
SITE_ACTIVE_MIN_DATE	Indicates when the site was first set to Active.
SITE_ID_NAME	The site ID, as entered when the site was created or last modified.
SITE_INACTIVE_MAX_DATE	Indicates when the site was most recently set to Inactive.
SITE_INACTIVE_MIN_DATE	Indicates when the site was first set to Inactive.
SITE_IS_ACTIVE	Indicates whether the site is currently active (Yes/No)

Organization folder

This table describes the data elements included in the Organization folder.

Table 3-47 Data elements in the Organization folder

Data element	Description
HAS_MSA	Indicates whether the Master Service Agreement is included for the institution.
MSA_END_DATE	Indicates the end date on which the Master Service Agreement is applied.
MSA_START_DATE	Indicates the date on which the Master Service Agreement is applied.
ORG_CATEGORY	Indicates the category for the institution you are creating (Hospital, Teaching Hospital, Medical Clinic, or Other).
ORG_ID_NAME	Indicates the institution's ID number.
ORG_INT_IDENTIFIER	Indicates the integration ID (if applicable).
ORG_NAME	Indicates the name of the institution
ORG_STATUS	Indicates the status for the institution ( Active by default; Active when ready to begin the study conduct period; Restricted when the institution can no longer be active in a study at your organization
ORG_TAX_IDENTIFIER	Indicates the institution's Tax Identification Number (TIN).
ORG_TIMEZONE	Indicates the time zone of the institution (for example, UTC +5 New York).
VAT NUMBER	Indicates the institution's Value Added Tax identification number.
WEBSITE	Indicates the institution's valid web URL.

Address folder

This table describes the data elements included in the Address folder.

Table 3-48 Data elements in the Address folder

Data element	Description
ADDRESS_1	Indicates the first line of the address (typically building street number, street name, and any unit number).
ADDRESS_2	Indicates the optional or secondary address line.
ADDRESS_TYPE	Indicates the type of address associated with the contact or organization (Primary, Billing, Shipping, or Alternate).
ALT_PHONE	Indicates an alternative phone number of the contact or organization (if needed).
CITY	Indicates the city associated with the contact or organization.
COUNTRY	Indicates the country associated with the contact or organization.
FAX	The fax number associated to the site's main primary address, as entered when the site was created or last modified.
IS_MAIN_PRIMARY	Indicates whether this address is the main primary address associated with the contact or organization.
PHONE	The phone number associated to the site's main primary address, as entered when the site was created or last modified.
STATE_PROVINCE	Indicates the state associated with the contact or organization.
ZIP_POSTAL_CODE	Indicates the ZIP or postal code associated with the contact or organization primary address.

Country folder

This table describes the data elements included in the Country folder.

Table 3-49 Data elements in the Country folder

Data element	Description
SITE_COUNTRY	Indicates the country associated with the site.

Investigator folder

This table describes the data elements included in the Investigator folder.

Table 3-50 Data elements in the Investigator

Data element	Description
DEGREE	Indicates the Investigator’s degree as entered (for example, PhD).
FIRST_NAME	Indicates the Investigator’s first (given) name as entered when the contact record was created or last updated.
INV_DEA_EXP	Indicates the expiration date selected for the investigator’s DEA registration.
INV_DEA_NUM	Indicates the investigator’s Drug Enforcement Administration (DEA) registration number as entered.
INV_EXEMPTION_NUM	Indicates the investigator’s exemption number as entered.
INV_IDENTIFIER	Indicates the investigator’s unique identifier as entered (letters and numbers allowed).
INV_INT_IDENTIFIER	Indicates the investigator’s internal identifier as entered, if used by the organization (letters and numbers allowed).
INV_LISC_NUM	Indicates the investigator’s licensed research number as entered.
INV_MED_IDENTIFIER	Indicates the investigator’s medical identifier as entered (letters and numbers allowed).
INV_NPI	Indicates the investigator’s National Provider Identifier (NPI) as entered.
INV_SPECIALTY	Indicates the investigator’s primary medical specialty selected from the available list.
INV_STATUS	Indicates whether the contact is set to Active (can work at a site and enter data) or Restricted (cannot be associated with a site or enter data).
INV_SUB_SPECIALTY	Indicates the investigator’s sub-specialty selected from the available list (if applicable).
INV_TAX_IDENTIFIER	Indicates the investigator’s Tax Identification Number (TIN) as entered.
INV_TIMEZONE	Indicates the Investigator’s time zone selected from the available list; daylight saving time adjustments are applied automatically where applicable.
LAST_NAME	Indicates the Investigator’s last (family) name as entered when the contact record was created or last updated.
MIDDLE_NAME	Indicates the Investigator’s middle name as entered when the contact record was created or last updated (if provided).
PREFIX	Indicates the Investigator’s name prefix selected from the available list (for example, Mr., Ms., Dr.).
SUFFIX	Indicates the Investigator’s name suffix selected from the available list (if applicable).

SDV Setting folder

This table describes the data elements included in the SDV Setting folder

Table 3-51 Data elements in the SDV Setting folder

Data element	Description
SDV_STRATEGY_NAME	Name of the SDV Strategy, as entered by the study manager.
INIT_SUBJ_COUNT	Indicates the number of initial subjects whose data must be verified at a site, as configured in the SDV strategy.
INITIAL_SUBJECTS_COUNT	Total count of initial subjects in a site that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
REMAIN_SDV_TYPE	Indicates the SDV type applied to the remaining subjects selected for verification (either 100% SDV or SDV for All Subjects & Critical Variables).
REMAIN_SUBJ_PERC	Indicates the percentage of remaining subjects to be randomly selected for verification after the initial subject count is reached, as configured in the SDV strategy.

Reference folder

This table describes the data elements included in the Reference folder

Table 3-52 Data elements in the Reference folder

Data element	Description
COUNT	Represents the count of sites.
DH_TIMESTAMP	A timestamp that indicates when the data became available in the dataset.
SITE_WID	A number that represents the unique identifier of a site.
SOFTWARE_VERSION_NUMBER	A number that increases incrementally every time a data point is modified.
STUDY_WID	A number that represents the unique identifier of the study.
USER_WID	Indicates a user's numeric identifier.
CURRENT_STUDY_ROLE_WID	Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user.

Supply Setting folder

This table describes the data elements included in the Supply folder

Table 3-53 Data elements in the Supply Setting folder

Data element	Description
RESUPPLY_TYPE	Indicates the type of the resupply strategy (either Dynamic or MinMax)
SUPPLY_STRATEGY_NAME	Indicates the name of the supply strategy.

Audit folder

This table describes the data elements included in the Audit folder

Table 3-54 Data elements in the Audit folder

Data elements	Description
COMMENTS	Required comment in a reason for change if ‘Other’ is selected. Populated as Rule Execution for calculated values. Default is null.
CURRENT_STUDY_ROLE_NAME	Specifies of the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user.
IS_CURRENT	Audit trail field to display either current status or full audit trail of the data. Note: For repeating forms, 2-section, and lab forms, this element is associated with both form-level records and row-level records. For form records in skipped visits, forms are not current and IS_CURRENT is set to N.
OBJECT_VERSION_NUMBER	Audit trail field that represents the version number of the data.
OPERATION_TYPE	Audit trail field that represents the type of operation performed on the record: CREATED MODIFIED REMOVED CLEARED Note: For form records in skipped visits, OPERATION_TYPE is set to CLEARED.
REASON	Indicates a reason for changes in a subject's data. Populated by drop-down list. Default is null.
USER_NAME	Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS.
VERSION_END	Indicates when the record became non-current. Current records use a far-future placeholder end date, for example, year 3099.
VERSION_START	Indicates the date and time when the site study version was first applied (for example, when the site was updated to this study version.