Defining DCIs

A DCI includes one or more DCMs and corresponds to a CRF.

Note:

A DCI's size directly affects how long it takes for end users to open and save CRFs in RDC Onsite. Avoid designing Oracle Clinical DCIs with more than 250 fields. Do not exceed 500 fields per DCI.

For more information, see:

• Creating a DCI
  
• Adding DCMs to DCIs
  
• Defining DCM Pages
  
• Copying a DCI
  
• Marking a DCI as Critical for Source Data Verification
  
• Deleting a DCI
  
• Defining DCI Access at the Study Level
  
• Defining Custom Reviews Required at the DCI Level
  

Creating a DCI

You can create DCIs directly from a DCM definition, by copying a DCI, or "manually" in the DCI window:

• When you make a DCM active, you have the option of creating a DCI that has the DCM subset name. You can choose the Create option to create the DCI as Provisional, or the Create and Activate option to create and activate the DCI.

• From either an Active or a Provisional DCM, choose Create a Default DCI from the Special menu to create a provisional DCM that has the DCM subset name.

  Note:

  If a DCI has already been manually created for a Provisional DCM (and no other DCMs), the system allows you to activate the existing DCI or to create a new one, depending on whether the existing DCI's name or short name is the same as the DCM subset name.

  If either the DCI's name or short name is the same as the DCM subset name, the message says, "Make corresponding DCI active also?" If you choose Yes, the system makes the DCI Active.

  If they are different, the message says, "'Create Default DCI." If you choose Create, the system creates a new provisional DCI. If you choose Create and Activate, the system creates a new active DCI.

• Copy a DCI from the Global Library or from a study; see Copying a DCI.

• If the DCI has many DCMs, create a DCI in the Maintain Study DCIs window:

  1. Navigate to Definition, DCIs, then DCIs. The Maintain Study DCIs window opens.

  2. Refer to the online help for information on each field.

     The Collect Time? setting determines if the DCI Time field appears in the Log-In form.

Adding DCMs to DCIs

In the Maintain Study DCIs window, click the DCI Modules button to reach the Data Collection Modules window. Copy either a Library DCM or a study DCM into the DCI using the Special menu.

Any changes you make apply only to the DCM in the context of this DCI, where it is also known as a DCI Module. Some DCI Module attributes, such as qualifying values and Clinical Planned Events, are available only in the context of a DCI.

Enter values as follows:

• Disp Seq # Controls the order in which the DCMs appear in the Received DCMs window.

• Planned Event If provided, forces the received DCM to be logged in for that clinical planned event and cannot be changed during login. You could use this feature to structure a DCI for a CRF containing multiple predefined visits.

  If you leave the Planned Event field empty, at login you can create received DCMs for as many unique CPEs as there are on the CRFs. You might do this when you have a CRF that collects multiple CPEs, but allows the name of the event to be entered by the Investigator (instead of being preprinted).

• Qualifying Value If provided for a qualified DCM, forces the RDCM to be logged in for that particular qualifying value and cannot be changed during login. You could use this feature to structure a DCI for the particular variant of a CRF that collects information about the particular qualifying value. For instance, with two identical CRFs, one preprinted for information about the right eye and one for the left eye, you could create two DCMs, one with RIGHT as the qualifying value, and one with LEFT.

  If you leave the Qualifying Value field empty, you can create received DCMs at each visit for as many unique qualifying values as are defined for the Qualifying Question. You might do this when you have a CRF that collects a group of Questions about, for example, multiple culture sites, but that allows the name of the culture site to be entered by the Investigator (instead of being predefined on the CRF). At login, you could create a received DCM for each culture site named on the CRF.

• Use DCI Date? Determines whether the received DCM created at login automatically inherits the date and clinical planned event (and time if used) entered for the DCI. If so, the date and clinical planned event (and time) cannot be changed at the received DCM level.

  Note:

  If you have chosen to collect the time, also check this box to collect the DCI Date.

• Collect Time? If checked, the Time field is enterable at login.

• Optional? Invokes a special behavior during login. You can only specify that a DCM is optional in a DCI if there is a single DCM in the DCI. At login, you can enter as many received DCMs for an optional DCM as are allowed by the study definition.

• Start Page and End Page Display only; see Defining DCM Pages.

• DCM Available The system checks this value if the DCM Graphic Layout is available. This field is read-only.

• Show Qual Value? Select this setting if the DCM has a Qualifying Question and you want to display the Question and text. If selected, the system includes the Qualifying Question in the DCM Header. If there is no Qualifying Question for the DCM, you cannot select this field. If there is a Qualifying Question, but no value for the qualifying value on the DCI Modules window, the system selects this field and prevents you from changing it.

• Show Lab? Select this setting if the DCM has a lab Question and you want to collect the name of the lab for the DCM. If selected, the system includes the lab Question in the DCM Header. You cannot select this field if there is no lab Question.

• Visit Display This field controls the display of Visit Name and Subevent Number. Here is a description of the available values:

  • NAME ONLY The system displays only the Visit Name on the DCI Form.

  • NAME+SUB# The system displays the Visit Name and Subevent Number as one field with a period separator (for instance, CHECKUP.1).

  • NAME/SUB# The system displays the Visit Name and Subevent Number as separate fields.

  • HIDDEN The system hides the Visit Name and Subevent Number in the DCM Header. If there is no defined CPE, or the Use DCI Date setting is deselected, you cannot select value HIDDEN for the Visit Display.

• Show Blank? If this box is selected, the system generates a Blank box in the DCM Header.

• Show Data Comment? If selected, the system includes the Data Comment in the DCM Header. You can only enter data through the Oracle Clinical Data Entry subsystem. Select this field if you want the data comment to show in the PDR.

• Show Comment? If selected, the system includes the Comment in the DCM Header. You can only enter data through the Oracle Clinical Data Entry subsystem. Select this field if you want the comment to show in the PDR.

Defining DCM Pages

Use this window only if you are using the Page Tracking feature for a paper-based trial. See Using CRF Page Tracking.

If a DCI spans multiple pages, specify which questions go on which page by defining the final Question on each page in the Data Collection Module Pages window.

From the DCI Modules page, select the DCM and click the DCI Modules Pages button.

Copying a DCI

If there is a DCI in the Global Library or in another study that suits your needs, you can copy it into the current study—rather than creating it from scratch—by selecting one of two copy options. To copy a Global Library DCI:

1. Navigate to Definition, then DCIs, and DCIs.

2. Select either Copy Lib DCI or Copy Study from the Special menu. Either the Locate Library DCIs or the Locate Study DCIs form appears, according to your selection.

3. Query for the DCI you want to copy.

4. Click either:

   • OK button to perform the copy

   • Cancel to return to the Maintain Study DCIs form without making a copy

Follow this procedure to copy an existing study DCI:

1. Navigate to Definition, then DCIs, and DCIs.
2. Select Copy Study from the Special menu. The Locate Study DCIs form appears.
3. Enter the study name to copy from.
4. Click the OK button to perform the copy, or Cancel to return to the Maintain Study DCIs form without making a copy.

Marking a DCI as Critical for Source Data Verification

Critical CRFs must be verified against source data for all patients. You can designate a CRF as critical by marking the DCI on which it is based as critical, either in the global library or in a study.

• To mark a DCI as critical at the study level, go to Definition, DCIs and then select DCIs. Mark the SDV? check box for the critical DCI.

• To define the DCI critical at the Global Library level, select Glib, then DCIs DCMs Procedures, and then select DCIs. Mark the SDV? check box for the critical DCI.

See Setting Up Partial Source Data Verification for more information.

Deleting a DCI

Under some circumstances you can delete a DCI by selecting it and then selecting Delete Record from the Data menu.

The system gives a warning if you delete a DCI that is associated with a Rule in an enhanced DCI Book for the study. If you proceed with the deletion you must delete the Rule or delete the DCI from the Rule before you can validate the DCI Book.

Defining DCI Access at the Study Level

You can define access to particular DCIs at the study level by overriding the default user role access settings. Here are two example situations:

• A local laboratory's personnel require RDC access so they can enter their lab results directly. However, lab personnel must only have access to the specific laboratory CRF and no others. An administrator can create a user role for the local laboratory personnel and you can restrict access for that role to the DCIs relevant to the lab's CRFs.

• The Patient Data Report includes only data in DCIs to which the user who runs the report has access. If the role of the user who runs the report does not have access to a particular DCI, the report does not include any data for the patient for that DCI.

The default user role settings, defined at the installation level, are either completely restricted or completely unrestricted. At the study level, you can override these settings and for any user role, specify either a list of DCIs that this role can see (an Inclusion list), or cannot see (an Exclusion list).

Note:

If a user does not have access to a study based on the defined study-level or site-level access, the study DCI access cannot provide the user with access to the DCI or to the study.

To specify DCI access at the study level:

1. Create the default user roles. (See the Oracle Clinical Remote Data Capture Administrator's Guidefor more information.)
2. In Oracle Clinical, navigate to Definition, then DCIs, and then DCI Access. (Users with Maintain privileges can see both the DCI Access and Query DCI Access navigation options. Users with Browse privileges can see the Query DCI Access option.)
3. Choose a study and click OK. The DCI Access window opens with the current study displayed in the title bar. (You can click the Change Study button at the bottom of the DCI Access window to select another study. You can also select Special, then Select Study.)
4. In the User Role section, select the first empty row and enter a valid user role name. You can also open the list of user role values, and choose a user role.
5. In the DCI List Type section, open the list of values in the same row as the User Role row you selected in the previous step. You have two choices:

   • Select EXCLUSION to allow the user to see everything except the listed DCIs.

   • Select INCLUSION to allow the user to see only the listed DCIs.

   The administrator sets default value for the DCI List Type field.

6. In the DCI Name section, enter a DCI name, or select a DCI from the list of values. The list of values includes all DCIs defined in the study.

   You can also leave the DCI Name field empty. An empty DCI list is interpreted differently:

   • EXCLUSION: The user has access to all DCIs. This approach may be taken when the default DCI access for the role is Restricted, but for a specific study the user role has access to all DCIs.

   • INCLUSION: The user has access to no DCIs for this study. This approach may be taken when the default DCI access for the role is Unrestricted, but for a specific study the user role has access to no DCIs.

     Note that for individual users, you can accomplish the same access with study security.

7. In the Access section, select the type of access to allow for this DCI. Your options vary depending on whether you are including or excluding access to the DCI.

   If the DCI List Type is set to INCLUSION you can select:

   • Default study/site privileges: Indicates that the DCI is accessed according to the user's study or site privileges.

   • Browse: Indicates that the user role can open and view the DCI only in browse mode.

   If the DCI List Type is set to EXCLUSION, you can select:

   • None: The user role cannot access the DCI.

   • Browse: The user role can open and view the DCI only in browse mode.

8. Continue to define the DCIs that this user role can access (include and exclude).
9. Save.

Defining Custom Reviews Required at the DCI Level

1. Expand the Definition node, then expand DCIs, and then select DCIs.
2. Select or switch to the study to which the DCI belongs.
3. Select the Review Requirements tab.

   Tip:

   The checkbox Allow CRF status change to RN when review is required? at the top of the tab is read-only and indicates the inherited installation or study setting, if one is defined. You can specify a different setting for individual custom review types in step 7.

4. Query in the DCI Name field for the DCI for which you want to set the custom review requirements.
5. Click in the Custom Reviews Required field for that DCI to open the Reviews Required dialog box.
6. Select (highlight) all the review types that should be required for this DCI.

   Tip:

   Clicking a single review type drops the current selection and selects only that review type. Use Shift+click, Ctrl+click, or the controls below the list to select or deselect multiple review types.

7. Make sure that Allow Override RN Status is checked for only those selected (required) review types for which you want to allow reviewers to set the review status to Review not Required (RN).
8. Click Save.

For information about custom review types, see chapter "Configuring Custom Review Types" in the Oracle Clinical Remote Data Capture Administrator's Guide.