System Configuration page

1

Enroll subject with incomplete form

Yes or No (default). Indicates whether the InForm application permits a subject to be enrolled with incomplete screening or enrollment information, after override authorization.

2

Require a comment when entering N/A, Unknown, or Not Done

Yes or No (default). Indicates whether the InForm application requires a user to enter a comment when selecting N/A, Unknown, or Not Done on the Comment page instead of filling in a question on a CRF.

3

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.

4

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.

5

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.

6

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 InForm application.

Note: Before this option can take effect, you must stop and restart the study.

7

Automatically answer manual queries

On (default) or Off. Indicates whether the 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.

8

Maximum length of query text

Maximum number of characters of query text displayed below an item on a CRF. The default is 350 characters.

9

Require unique subject initials and date of birth

Study, Site, or None (default). Indicates whether the 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.

10

Require unique subject ID

Study (default), Site, or None. Indicates whether the 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 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 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.

11

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. For more information, see Frozen and locked forms and batch run calculation rules.

12

Order of UserName in Signature

Order of the names in the signature.

• FirstName,LastName (default)
• LastName,FirstName

13

Execution plan server

Name of the server(s) on which execution plans run.

14

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.

15

Reporting service full url

URL for the Cognos 10 BI Web service.

16

Reporting Internal URI

Cognos parameter that is set when running the CRNConfig installer. It is an internal URI that the 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.

17

Reporting authentication namespace ID

LDAP namespace that is used to authenticate InForm users on the reporting server.

18

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.

19

Date format

The format in which you want the date to appear in the study.

• Month / Day / Year
• Day / Month / Year
• Year / Month / Day

20

Allow subject ordering

Enabled or Disabled (default). Indicates whether to allow use of the subject ordering feature.

21

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.

22

Trial Center Url

Not supported.

23

Form submit notification style

The location and format of the Form submitted successfully message.

• Inline (default)—Message displays in the header of the form.
• Pop-up—Message displays as a pop-up. User must click OK in order to proceed. Default.

This setting is global to all users.

24

Inline notification visible duration

Used when Form submit notification style is Inline.

Specifies the number of seconds that the Form submitted successfully message remains visible in the header of the form before it fades.

Specify a value from 0 to 9 seconds. The default is 3 seconds.

A value of 0 (zero) causes the message to remain visible until the user performs an action on the form, such as changing a value or entering focus to a control.

25

QuerySelection

Specifies whether queries are created in the Opened or Candidate state.

• Create Query in Opened State
• Create Query in Candidate State

26

Re-authentication inactivity period

Number of minutes of inactivity that can pass before the InForm application requires a user to log in again.

27

Password expiration period

Number of days that can pass before the InForm application requires users to change their passwords.

Recommended setting is 90 days.

28

Re-identification period

Number of minutes that a session can be active before the InForm application requires a user to log in again.

29

Minimum password length

Number of characters that must be in the password. 

Recommended setting is 8 characters.

30

Inactivate account after number of failed log-on attempts

Number of times a user can attempt to log in with an incorrect user name and password combination before the account is inactivated and an execution plan is run, if defined, to send an email notification.

Recommended setting is 3.

If an account is inactivated, an administrator must reactivate the account. 

31

Require at least one numerical character in password

Yes (recommended) or No. Indicates whether users are required to use at least one numerical character in their passwords.

32

Require at least one uppercase character in password

Yes (recommended) or No. Indicates whether users are required to use at least one uppercase character in their passwords.

33

Require at least one non-alpha-numeric character in password

Yes (recommended) or No. Indicates whether users are required to use at least one non-alphanumeric character in their passwords. 

34

Allow password reuse

Yes or No (recommended). Indicates whether to allow users to reuse previous passwords.

35

Enable password recovery

Yes (recommended) or No. Indicates whether to allow users to request a password reset if they have forgotten their password.

36

Email address for password recovery notification

The email address of an administrator who receives notification when a user requests a password reset.

37

Email address for new site and user notification

The email address of an administrator who receives notification when a new site or new user is added.

40

Enforce visit date entry (Required before other data can be entered.)

41

Screening number sequence format

42

Subject number sequence format

43

Default randomization source manager

44

Randomization format for simple site

45

Randomization source manager for simple site

46

Randomization format for simple central

47

Randomization source manager for simple central

48

Randomization for central stratified by site

49

Randomization source manager for central stratified by site

50

Randomization format for central stratified

51

UNC download directory (Used only in legacy systems.)

52

Virtual download directory (Used only in legacy systems.)

53

View CRF signature list

54

Display form status with traffic light icons

55

Reporting Database

57

Reporting CAP Admin Database

58

Reporting CAP Admin Database User

59

Reporting User Name

Audit Trail icon

Navigates to the audit history for the item.

Update

Updates system configuration changes to the database.