Site Folder

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

Note:

A site may have multiple addresses added that are used for different purposes (primary address, shipping address, billing address, alternate address), but only one address can and must be configured as the main primary address.
  • Only a site's main primary address is transmitted to Oracle Clinical One Analytics for the address data elements (those starting with ADDRESS_).
  • The shipping address data elements (those staring with SHIPPING_) return the site's shipping address details only if added in Clinical One Cloud Service, otherwise it will return null.

    If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.

Table 3-78 Data elements in the site folder

Data element Description
ADD_SUBJECTS
Setting defined at the study site level to allow site users to add subjects. Values can be:
  • true
  • false
ADDRESS_CITY

The city of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_COUNTRY

The country of the site's main primary address, as entered when the site was created or last modified.

This field displays the country's two-digit ISO code.
ADDRESS_POSTALCODE

The zip postal code of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STATE_OR_PROV_OR_CNTY

The state, province or county of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STREET_1

The first line of the site's main primary address, as entered in the Address Line 1 field when the site was created or last modified.
ADDRESS_STREET_2

The second line of the site's main primary address, as entered in the Address Line 2 field when the site was created or last modified.
DEA_NUMBER

The DEA registration number of the site's contact.
DISPENSE_TO_SUBJECTS
Setting defined at the study site level to allow site users to dispense kits to subjects. Values can be:
  • true
  • false
DRUG_DESTRUCTION_CAPABLE
Indicates if the site has drug destruction capabilities. Values can be:
  • true
  • false
EHR_ENABLED
Indicates if a site is currently enabled for Electronic Health Record (EHR) data import.
  • Displays Y (yes) for sites currently enabled for EHR data import.
  • Displays N (no) if EHR has never been enabled for a site or if a site was disabled for EHR.
EMAIL

The email address associated to the site's main primary address, as entered when the site was created or last modified.
EXPIRATION

The expiration date of the DEA registration number of the site's contact.
FAX

The fax number associated to the site's main primary address, as entered when the site was created or last modified.
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.
INITIAL_SUBJECTS_SDV_TYPE
Type of Source Data Verification (SDV) applied to initial subjects, as defined in the SDV strategy. Values can be:
  • All Questions: meaning all questions must be verified for the subject.
  • Critical Questions Only: meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
INVESTIGATOR

Last name of the principal investigator associated with the site.
PHONE

The phone number associated to the site's main primary address, as entered when the site was created or last modified.
PI_PREFIX
Indicates the prefix for the site's principal investigator. Values can be:
  • First Liutenant
  • Admiral
  • Attorney
  • Brother
  • Captain
  • Chief
  • Commander
  • Colonel
  • University Dean
  • Doctor
  • Elder
  • Father
  • General
  • Fees
  • Honorable
  • Liutenant Colonel
  • Major
  • Major/Master Sergeant
  • Mister
  • Married Woman
  • Single or Married Woman
  • Prince
  • Professor
  • Rabbi
  • Reverend
  • Sister
RANDOMIZE_SUBJECTS
Setting defined at the study site level to allow site users to randomize subjects. Values can be:
  • true
  • false
REMAINING_SUBJECTS_PERCENTAGE

Percentage of remaining subjects in a site, after the initial subjects, that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
REMAINING_SUBJECTS_SDV_TYPE
Type of Source Data Verification (SDV) applied to the remaining subjects, as defined in the SDV strategy. Values can be:
  • All Questions: meaning all questions must be verified for the subject.
  • Critical Questions Only: meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
SCREEN_SUBJECTS
Setting defined at the study site level to allow site users to screen subjects. Values can be:
  • true
  • false
SDV_GROUP_NAME

Name of the SDV strategy that is associated with the site. This name is entered by the user when creating an SDV strategy.
SHIPPING_ADDRESS_1

The first line of the site's shipping address, as entered in the Address Line 1 field when the site was created or last modified.
SHIPPING_ADDRESS_2

The second line of the site's shipping address, as entered in the Address Line 2 field when the site was created or last modified.
SHIPPING_ATTENTION

Indicates the name of the person who will receive shipments at the site, as specified when the site was created or last modified.
SHIPPING_CITY

The city of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_COUNTRY

The country of the site's shipping address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.
SHIPPING_EMAIL

The email address associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_FAX

The fax number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_PHONE

The phone number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_STATE_OR_PROV_OR_CNTY

The state, province, or county of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_ZIP

The zip postal code of the site's shipping address, as entered when the site was created or last modified.
SITE_ID_NAME

The site ID, as entered when the site was created or last modified.
SITE_NAME

Name of the site, as entered when the site was created or last modified.
SITE_STATUS
Indicates the status of the site within the study. Values can be:
  • New: the site is new within the study.
  • Active: the site is currently active within the study.
  • Retired: the site is no longer active in the study.
SITE_STUDY_VERSION

The latest study version associated with the site. This is defined in the Sites & Labs tab of the study's settings.
SITE_TYPE
Indicates the type of organization. Values can be:
  • Site
  • Depot
TIMEZONE

Indicates the time zone for the site, as specified when the site was created or last modified.

Values can be, for example, EST5EDT or America/New_York. Depends on the selected value in Clinical One Cloud Service.

Parent topic: Subject Safety Case dataset