Fields—Optional System Configuration

Field Description
Enroll subject with incomplete form Yes or No (default). Indicates whether the Oracle InForm application permits a subject to be enrolled with incomplete screening or enrollment information, after override authorization.
Require a comment when entering N/A, Unknown, or Not Done Yes or No (default). Indicates whether the Oracle InForm application requires a user to enter a comment when selecting Not Applicable, Unknown, or Not Done on the Comment page instead of filling in a question on a form.
Display Comment Text Boxes

Yes (default) or No. Indicates whether to enable a text box where users can enter a comment for a form or item. If you select Yes for Require a comment when entering N/A, Unknown, or Not Done, you can't select No for FreeCommentTextBox.

If you select No, existing comments appear as read-only text, and the option to select Not Applicable, Unknown, or Not Done in the Reason incomplete field is available only for items without data.

Show Unscheduled Yes (default) or No. Indicates whether to show the word Unscheduled in the visit title of unscheduled visits.
Post a query for conflict resolution Yes or No (default). Indicates whether to create a query when, during communication with the Central Coding application, data is found to be entered into a data item by the two different servers.
Number of execution plan listener threads Number of threads running in the background to process pending execution plans. The default is 4; at least 1 is required for any execution plans to run.

Number of Workflow Update threads

Number of threads running in the background to process the workflow update. This value is set during study setup, and typically only needs to be set one time per study. The default value is 2.

Caution:

You should not adjust this setting without input from Oracle Global Support. If the performance of your study deployment or study migration is too slow (for example, timeouts happen), contact Oracle Global Support for assistance.
Number of execution plan re-submits Maximum number of times to retry submission of a failed execution plan before it is logged as an error in the event log and removed from the queue of execution plans to be run. The default is 2.
Enable SSL On or Off (default). Indicates whether Secure Sockets Layer should be enabled to provide encryption of data. Secure Sockets Layer is an encryption protocol that is provided with the browser software used to run the Oracle InForm application.

Note:

Before this option can take effect, you must stop and restart the study.
Automatically answer manual queries On (default) or Off. Indicates whether the Oracle InForm application automatically changes a manual query state to Answered when a data item is updated.

Note:

Regardless of this setting, the query workflow always performs an auto-answer when the Update Data and Answer option is used.
Maximum length of query text Maximum number of characters of query text displayed below an item on a CRF. The default is 350 characters.
Require unique subject initials and date of birth Study, Site, or None (default). Indicates whether the Oracle InForm application requires a unique combination of subject initials and date of birth for a study, a site, or not at all.

Note:

If you specify that unique initials and date of birth are not required, and subjects with duplicate initials and date of birth are entered, and later you specify that unique IDs are required, the duplicate information that was entered previously will not be reported.
Subject record transfer consideration: If you plan to allow the transfer of subjects from one site to another, set the UniqueIntIDOBSwitch attribute to require unique initials and DOB across the study. This prevents the following situation:
  • If a study does not require unique initials and date of birth, or only requires site uniqueness, and a user transfers a subject to a site where another subject exists who has the same initials and date of birth, the subject transfer fails.
  • To transfer the subject, the user must change the subject initials to make the combination unique.
Require unique subject ID Study (default), Site, or None. Indicates whether the Oracle InForm application requires a unique subject number for a study, a site, or not at all.

Note:

If you specify that a unique subject number is not required and subjects with identical numbers are entered, and later you specify that unique subject numbers are required, the duplicate information that was previously entered will not be reported.

Subject record transfer consideration: If you plan to allow the transfer of a subject from one site to another, set this option to require subject numbers to be unique across the entire study. The Oracle InForm application does not allow a subject to be transferred to another site in which a subject exists with the same subject number. If a conflict arises, the Oracle InForm application rejects the transfer, and you must manually change the subject number of the transferring subject to a value that is not duplicated at the target site.

Partial SV consideration: If you plan to use partial source verification, set this option to Study or Site.

Allow sponsor users to edit frozen forms

Yes or No (default). Indicates whether sponsors will be able to edit a CRF after it has been marked as frozen.

Batch run calculation rule consideration: If you plan to run calculation batch rules on case report books that are unfrozen and unlocked, but that have individually frozen forms, set this option to Yes to prevent errors.

Order of UserName in Signature
Order of the names in the signature.
  • FirstName,LastName (default)
  • LastName,FirstName
Visit Calculator Enabled or Disabled (default). Indicates whether you want the Visit Calculator to appear after a successful enrollment.
Execution plan server Name of the server(s) on which execution plans run.
MedML installation server/reporting administration server Name of the server that is defined as the server on which all MedML, including changes to a study, is installed.
Reporting service full url URL for the Cognos Analytics 11 Web service.
Reporting Internal URI Cognos parameter that is set when running the CRNConfig installer. It is an internal URI that the Oracle InForm server uses to communicate to the Cognos server. The information can be found in cogstartup.xml. Example: http://appsru02.north.pf.com:9300/p2pd/servlet/dispatch.
Reporting authentication namespace ID LDAP namespace that is used to authenticate Oracle InForm users on the reporting server.
Reporting user root

The top-level reporting folder for the company. Use this field only if you are hosting several companies on one reporting server and have set up reporting folders for each company.

Leave this field blank if you are not hosting studies for different companies, or if you have not set up separate reporting folders for each company.

Date format The format in which you want the date to appear in the study.
Allow subject ordering Enabled or Disabled (default). Indicates whether to allow use of the subject ordering feature.
Server friendly name

User-friendly server name to display on the Queries details and Signature Status Details pages.

Note:

You can set this option only through the Admin user interface; there is no equivalent MedML tag.
Trial Center Url Not supported.
Allowed Rule Objects The object names that are in the allowed rule objects list. READ-ONLY
Set itemset to Not Verified
When to set a Verified itemset to Not Verified in Oracle InForm.
  • When any SV Required item is changed—A Verified itemset is set to Not Verified any time an item in the itemset that is marked SV Required is modified.
  • When any item is changed (Default)—A Verified itemset is set to Not Verified any time an item in the itemset is modified.