Specify study settings
Configure study-level settings to control study behavior across modes. Some options are mode-specific (Testing, Training, and Production), while others apply to all modes. Note that not all settings can be edited at any time.
Caution:
We recommend configuring and verifying them in Testing mode first.- Configure your study's settings appropriately and select Apply Changes. Refer to the table below for details about each setting.
- Select Apply to Production to apply the study settings only for your approved study.
- Select Apply to All Modes to apply the study settings in all three modes: Testing, Training and Production.
Note:
Not applicable for settings that can only be configured for an individual study mode, such as Assign Subject Number or Replace Subject Number with Randomization Number.In particular, for the Assign Subject Number setting, if you select Apply to All Modes, the system displays an error message, and prevents you from applying the setting change across all study modes.
Tip:
To view tips for completing a field, click into the field or choose an option.Table 4-2 Subject Management
Setting Can be changed anytime during the study conduct period Description Allow Subjects to be Manually Added Yes - Choose Yes to let site users manually add subjects to your study.
- Choose No to prevent site users from manually adding any subjects to your study.
By default, this setting is set to Yes.
Screen Failed Subjects Yes Note: Allow Withdrawal and Allow Completion are deselected by default.
If the Assign Subject Number setting is set to When subject is screened, the Allow Screen Fail before Screening option is unavailable.
- Select Allow Screen Fail before Screened to allow manual screen failure if subjects have not yet been screened.
- Select Allow Withdrawal to allow subjects that have failed screening to withdraw from the study.
- Select Allow Completion to allow subjects that have failed screening to complete the study.
Withdraw Subjects After Code Break Yes - Choose Yes if subjects are withdrawn from the study after a code break.
- Choose No if subjects shouldn't be withdrawn after a code break.
A code break is the unblinding of a subject's treatment arm.
Allow Withdrawal for Subjects before Enrollment Yes - Choose Yes to let site users withdraw subjects before they're enrolled.
- Choose No to prevent site users from withdrawing subjects before their enrollment.
Allow Rescreening Yes Note: A Rescreening visit must be present in the study's design.
Select Yes if you would like to allow and define the number of times a subject can be rescreened.
By default, this setting is set to No.
Maximum Rescreening Attempts Yes Note: This setting is only available when Allow Rescreening is set to Yes.
Enter the number of times a subject can be rescreened. If this field is left blank, the subject will be allowed unlimited rescreen attempts.
Lock All Screening/Rescreening Data after Screen Failure Yes Note: This setting is only available when Allow Rescreening is set to Yes.
Select this option if you would like all questions in the visit to be locked in the Screening/Rescreening visit if the subject is auto or manually screen failed.
Table 4-3 Subject Numbering Configuration
Setting Can be changed anytime during the study conduct period Description Assign Subject Number You can update this setting only if the study version and design meet the prerequisites for the selected study mode (Testing, Training, Production). To switch from When subject is added to When subject is screened, the following prerequisites must be met: - The Allow Subjects to be Manually Added setting is set to Yes.
- The study version assigned to the site in the selected mode must include a required Screening visit as the first visit in the schedule.
- The study must not include any subjects with a status of Active.
If these prerequisites are not met, the setting cannot be changed.
Note - You must configure this setting for each study mode individually.
- Choose When subject is added to assign a subject number when a subject is added into the study.
- Choose When subject is screened to assign a subject number after screening forms are submitted.
By default, this setting is set to When subject is added.
For more information about this setting and its impact, see Understand impact of subject number assignments on study data and Workflow for configuring a study to assign subject numbers after screening.
Allow Site to Select Subject Number Yes - Choose Yes to let site users select subject numbers.
- Choose No if subject numbers should be automatically generated.
By default, this setting is set to No.
Subject Number Format Yes Note: This setting is only available when Allow Site to Select Subject Number is set to Yes.
Specify the characters allowed at each position of the subject number, moving from left to right.For instance, you can use the expression [0-9] to indicate that in the first position only a single digit between 0 and 9 is allowed. For more details on how to define a subject number format, see What are my options for defining a subject's number format?
Subject Numbering Yes Note: This setting is only available when Allow Site to Select Subject Number is set to No.
- Choose Sequential in Study for sequential subject numbers across sites. For example, subject 1 at Site A, subject 2 at Site B, and subject 3 back at Site A.
- Choose Sequential at Sites if subject numbers are sequential within each site. For example, Sites A and B both have subjects 1, 2, 3, and so on.
First Subject Number Yes Note: This setting is only available when Allow Site to Select Subject Number is set to No.
Enter the number assigned to the first subject in either the study (if subject numbering is sequential in the study) or at each site (if subject numbering is sequential at each site).
Leading Zeros in First Subject Number Yes Enter the number of zeros to include at the beginning of the first subject number. Note that the number of leading zeros decreases as the number of digits in the subject number increases. For example, if you enter 3, the first subject number might be 0001, the 99th subject might be 0099, and the 100th subject might be 0100.
Include Hyphen Between Site and Subject Number Yes - Choose Yes to separate the site ID and subject number with a hyphen (for example, 001-001).
- Choose No for no hyphen (for example, 001001).
Replace Subject Number with Randomization Number You can only change this setting before the first subject is screened or enrolled in a specific study mode. If the setting is unavailable, a subject has already been screened in that mode. Note - You can only configure this setting for each study mode individually.
This setting is only visible when you're assigned the Manage Subject Number Configuration permission.
-
Choose Yes to automatically replace the subject number with the randomization number.
- Choose No to prevent the application from replacing the subject number with the randomization number.
By default, this setting is set to No.
For more information about this setting, see Study impact when replacing a subject number with the randomization number.
Blind Randomization Number Yes. This setting is only active if Replace Subject Number with Randomization Number is set to No.
- Choose Yes to hide subject randomization numbers in the system's user interface (UI) for your study. Blinded Randomization Number displays in place of the randomization number.
- Choose No to display subject randomization numbers in the UI for your study.
By default, this setting is set to No.
Note: Setting the Blind Randomization Number option to Yes, disables the Replace Subject Number with Randomization Number option.
Table 4-4 Display and Data Options
Setting Can be changed anytime during the study conduct period Description Hide the Visit Window Projection Yes - Choose Yes to hide the time frame for scheduled visits under the visit title on the Subjects page.
- Choose No to display the time frame for scheduled visits.
By default, this setting is set to No.
Display signature elements for site staff and sponsors No. Warning: Once you turn this setting on, you cannot turn it off, even if you haven't saved your change yet.
Note - You can only configure this setting for each study mode individually.
Choose Yes to allow the Signature widget (
) and Signature Request sidebar to appear in the UI for the corresponding study mode.
By default, this setting is set to No. If you change it to Yes, you can no longer change it back to No.
Code data for new and screen failed subjects Yes. You can change this setting at any time, even after data collection has started. Note: If a subject with the status of New or Screened is moved to Withdrawn or Complete, the verbatim terms entered under those statuses are sent to Oracle Central Coding, even though the subject never reached the status of Enrolled or Active.
That is because this setting, when set to No, does not prevent terms for subjects with the status of Withdrawn or Complete from being sent to Oracle Central Coding; it only blocks terms for Screen Failed subjects.
- Choose Yes to send all verbatim terms to Oracle Central Coding, regardless of the subject status. For more information, see Available subject statuses.
- Choose No to send verbatim terms to Oracle Central Coding once a subject reaches the status of Enrolled or Active.
Once a subject reaches one of those statuses, Oracle Central Coding also receives any verbatim terms entered before the subject reached that status.
By default, this setting is set to Yes.