Creating a Clinical Study

The Maintain Clinical Studies window is the starting point for creating a new clinical study. This window names and describes a clinical study, consolidating many of its details. You can create the new clinical study provided projects, organization units, and regions already exist in Oracle Clinical's Planning subsystem. You can also augment the details of a clinical study originating in the Easy Study Design facility.

Follow these instructions to create a new clinical study:

1. Navigate to Design, Studies, then Clinical Studies.
2. Click the Insert Record icon in the toolbar.
3. In the Study field, select a study code from the list of available codes. (Designers set these values in the Planned Studies window. See Creating Planned Studies.)
4. Enter, modify, or accept the short and long study titles.
   The system populates the Access field according to its designated randomization access. Designers with randomization privileges can set the list's values in the Amend Randomization (from the Design menu, select Randomization, then select Randomization Maintenance, finally choose Randomization Statuses).
5. Select the Pivotal Study? box if this is a pivotal study. Pivotal Study is an industry term indicating that failure terminates development of the drug.
6. Select the FDA? box if you expect to include the study's data in a submission to the FDA.
7. Save. When you exit, the system prompts you to confirm the creation. If you click Yes the system saves the record to the database and closes the window.

For more information, see:

• Maintaining Clinical Study Objectives
  
• Maintaining Enrollment Criteria
  
• Maintaining Study Termination Criteria
  
• Creating Clinical Study Comments
  
• Assigning Clinical Study Regions
  
• Maintaining a Clinical Study's Historical Events
  
• Reviewing Planning Details
  
• Updating Clinical Study Statuses
  
• Deleting a Clinical Study
  

Maintaining Clinical Study Objectives

In the Maintain Clinical Study Objectives window, you can create, update, or delete descriptions of clinical study objectives. A study can have any number of objectives. The study can have more than one objective for an objective type. The system automatically queries the objectives for the selected clinical study when you open the window.

Select an objective to work with or use the Insert Record function to add an objective.

Choose the objective's type. You must choose the type of objective from values set in the OBJECTIVE TYPE CODE codelist.

If you have more than one objective for a type, you can rank their importance by assigning them numbers in the Order field.

Select the Final Analysis? field if the objective should be taken into account during the study's final analysis. Leave it deselected if the objective is for interim analysis.

Describe the objective.

Maintaining Enrollment Criteria

Use the Maintain Enrollment Criteria window to create, update, or delete the enrollment criteria of participants in a study.

A clinical study can have any number of enrollment criteria. Use the multi-record window to view all the enrollment criteria already assigned to a study. The single-record window contains more complete names for the fields. In multi-record mode, the system sorts the list by the criteria flagged as inclusion criteria first.

To create, update, or delete the enrollment criteria:

1. From the Design menu, select Studies, then choose Clinical Studies. The Maintain Clinical Studies window opens.
2. Query for and select a study, then click the Enrollment button. The Enrollment Criteria for Study window opens.
3. Choose an enrollment criterion, or use the Insert Record data function to add a new criterion. Copy or write a description of the criterion in the Criteria Description field.
4. Select the Inclusion? field (labeled Is this one of the Inclusion Criteria? in the single-record window), if you use the criterion as a requirement a patient must meet to be included in the study. Leave the field deselected if you use the criterion to exclude patients from a study. Currently, the system does not use this information.
5. Select the Phone? field (labeled Used by Phone Randomization System? in the single-record window), if the criterion helps define a phone randomization system.
6. Select the Screening? field (labeled Used for Initial Screening? in the single-record window), if you use the criterion as an initial screening of patients. A blank field indicates the criterion applies to final enrollment into the study.
7. Enter a grouping code in the Group? field (Grouping code in the single-record window), if a criterion is an element of a set of criteria.

   The field is optional and accepts any value. The list of values shows the existing values for the study. Grouping criteria creates an OR logic condition. For example, to define a criterion for blood group A or B, you would group a criterion for blood group A, and a second for blood group B. You would join them with a code of A_OR_B.

8. Choose any factors to measure in the enrollment criterion. (A factor is a trait people share that may affect the outcome of a study.)

   To clarify a trait's influence, and to reduce the likelihood of an improperly distributed factor, regulate its distribution to randomization groups with the system's strata forms. Designers with randomization privileges can set the code values for factors in the Maintain Factors window (from the Design menu, select Strata, then choose Factors). Set minimum and maximum values to factors that are part of a range (type R). Set a single value for a single-value factor (type V).

Maintaining Study Termination Criteria

1. From the Design menu, select Studies, then select Clinical Studies, and click the Termination button.
2. Select a termination criterion to work with, or use the Insert Record function to add one.
3. Describe the conditions that constitute an early termination.
4. Select the Early Term? box (Is Criteria for Early Termination?, in the single-record window), if the termination criterion disqualifies a terminated patient's data from being part of the study's final analysis. Leave the field deselected if an early termination does not remove any of the patient's collected data from final analysis.
5. Select the Incl In Safety? (Include in Safety Analysis?, in the single-record window), box if the termination criterion disqualifies an early-termination patient's data from being included in the study's safety analysis. Leave this field deselected if an early termination does not remove any of the patient's data from the safety analysis.
6. Select the Incl In Efficacy? (Include in Efficacy Analysis?, in the single-record window), box if the termination criterion disqualifies an early-termination patient's data from being included in the study's efficacy analysis. Leave this field unchecked if an early termination does not remove any of the patient's data from the efficacy analysis.
7. Choose any factors to measure in the termination criterion. Designers with randomization privileges can set the code values for factors in the Maintain Factors window (from the Design menu, select Strata, then choose Factors). Set minimum and maximum values to factors that are part of a range (type R). Set a single value for a single-value factor (type V).

Creating Clinical Study Comments

A study can have any number of comments, and the system displays all comments for a study after you select it. You cannot update or delete a study comment. From the Design menu, select Studies, then choose Clinical Studies, and click the Comment button. Use the Insert Record function to add a comment. Create comments to record information that have no specific attributes. The system does not use the comments.

Assigning Clinical Study Regions

You can assign the regions to a study in this window. Study planners can create the values for regions in the Maintain Regions window (from the Plan menu, select Regions), or, from the Design menu, select Studies, choose Clinical Studies, and then click the Region button. The regions display by region code sequence. You can assign a region to a particular clinical study only once; however, a study can be conducted in more than one region and be expanded to include other regions than originally designated.

To maintain the regions for a clinical study, follow these steps:

1. Choose an assigned region, or use the Insert Record data function to add a new region.
2. Select the Regulatory? box if you include a region for regulatory reasons.
3. Select the Marketing? box if you include a region for marketing reasons.
4. Select the Reporting? box if this region is the region that appears in reports. Only one region can be the reporting region for a study.

Maintaining a Clinical Study's Historical Events

Historical events may be one of two kinds: event recording triggered by the system, or a user-defined event. Historical events triggered by the system include:

• Creation of this study

  Creation of a study version

• Setting or changing the randomization access codes for a study

• Setting or changing the randomization access codes for a study phase

• Setting or changing the study status

• Setting the live study flag

Examples of possible user-defined historical events are producing a first draft of a study, or sending a first draft to another location for review. You can create or display clinical study history records, but you cannot delete or change a history entry. You can record dates for events you expect to occur in the future. The system populates the Type field, assigning user-generated records the value USERDEF.

To create or maintain historical event information, from the Design menu, select Studies, then select Clinical Studies, and click the History button.

Reviewing Planning Details

Open this window to display planning data about a clinical study. From the Design menu, select Studies, then select Clinical Studies, and click the Planning button. These details are all set in the Planning subsystem. The system sorts and displays phases in chronological sequence.

The buttons along the bottom of this window open several Design utilities. The following section describes these utilities and some of the main fields.

Updating Clinical Study Statuses

Set the study status to classify the study according to its developmental maturity. The timestamp for each change in status appears in the study's history. Use the list function to set a study's status. Your company maintains study status values on the STUDY STATUS TYPE CODE codelist (from the Admin menu, select Reference Codelists, then choose Design Installation Codelists, and query STUDY STATUS CODE LIST). You can also set randomization access in this window.

The information you enter provides a basis for creating clinical study history records.

To update clinical study statuses:

1. From the Design menu, select Studies, then select Study Statuses.
2. Select the study of interest.

   Use the list and query functions, if necessary, to locate the study.

3. Enter the study status code.

Deleting a Clinical Study

Deleting a clinical study also deletes these elements associated with the study:

• enrollment criteria

• termination criteria

• objectives

• history

• regions

• comments

• versions and related records

To delete a clinical study, from the Design menu, select Studies, then select Delete Study. The Delete Clinical Studies window appears with a Clinical Studies window. The system displays all the current studies. Select the study you want to delete and click the Delete button. The clinical study disappears from the listing.

Note:

You receive an error message if you attempt to delete a clinical study with existing received DCIs; also, your company might place local safeguards.