Operating from the Study-Owning Location

A study-owning location has responsibility for the design and definition of a study. For the tasks involved in designing and defining a study, see Oracle Clinical Creating a Study.

This section describes the following elements of conducting a study that directly relate to replication:

• Changing Ownership and Replicating Patient Positions
  
• Maintaining Investigators and Sites
  
• Constraints at the Study-Owning Location
  
• Replicating Data at a Study-Owning Location
  

Changing Ownership and Replicating Patient Positions

Defining patient positions is part of defining a study. In defining patient positions, the study-owning location declares which location owns each patient position. You can change ownership later to a different location, as long as no data has been associated with the patient and no book has been assigned to the patient.

The process of changing the location of patient positions has two parts:

• The owning location must change the ownership.

• The receiving location must replicate, or retrieve, the patient positions.

For more information , see:

• Changing the Ownership of Patient Positions
  
• Retrieving Patient Positions
  

Changing the Ownership of Patient Positions

When you create patient positions, you can define the patient positions as screening, normal, or replacement.

To change the ownership of any type of patient position:

1. Navigate to Design, Patient Positions, and then select Change Ownership.

   The system displays a list of all studies. Select the study for which you want to change patient positions.

2. Click Change Owning Location.

3. Complete the fields in the Change Patient Position Owner window as follows:

   1. In the Location to own Patients field, enter the name of the location that is to receive ownership of the set of patient positions.

      If you are not the study owner, you can only change ownership back to the study-owning location.

   2. In each Number To Update field, enter the number of patient positions you want to process for each patient type. Note that you can process one, two, or all three types of patient positions (screening, normal, and replacement) by entering a number into the respective Number To Update field.

   3. In the Start patient-position Patient fields, enter the patient number to start with when changing the ownership. You can enter a starting number for each type of patient position (screening, normal, and replacement).

4. Click Change Owning Location to change the ownership.

After the study design is next replicated, the new owner will have control of these patients. The owner will be able to maintain their details, assign them to study sites, and enter data for them.

Retrieving Patient Positions

In a distributed study, the study-owning location controls the assignments of all patient positions. If a patient position currently owned by a sharing location must change ownership, the study-owning location must reclaim, or retrieve, ownership of the patient position first.

The study-owning location can reclaim ownership of a patient position from any sharing location provided no data has been entered for the patient.

To retrieve patient positions:

1. Navigate to Design, Patient Positions, and then select Retrieve Patients.

2. Complete the fields in the Replicate a Clinical Study window as follows:

   1. In the Source Study Code field, select the study that currently owns the patient positions. The list of values includes only those studies that are available for replication and that are owned by the current location. If only one study is available, the system automatically populates the field for you.

      Once you specify the source study code, the system automatically populates the Source Study Title field for you.

   2. In the Retrieve Patient From field, select the source location. The available locations are based on the active locations defined in the SOURCE LOCATION CODE installation codelist.

3. Click Retrieve Patients.

   Oracle Clinical processes and reclaims ownership of the specified patient positions provided no data has been entered for the patients.

Maintaining Investigators and Sites

Each study-sharing location assigns sites to the study and assigns investigators to those study sites. You cannot collect patient data without a study site and an assigned investigator.

Investigator and site names must be unique across all locations in the installation. Investigator and site information is replicated as part of data replication.

Constraints at the Study-Owning Location

Replication imposes constraints on design activity at the study-owning location. Although a few exceptions exist (see sections below), you cannot delete the following once they have been replicated:

• Patient positions

• Clinical study

• Clinical study versions

• Clinical planned events

• Treatment assignments

For more information , see:

• Exceptions for Patient Positions
  
• Exceptions for Study Design Activities
  

Exceptions for Patient Positions

The study-owning location creates patient positions and assigns them to various sharing locations. In general, you cannot alter patient positions after they have been assigned to a sharing location, except in the following circumstances:

• The study-owning location can reclaim ownership of a patient position from any sharing location provided no data has been entered for the patient.

• Sharing locations cannot exchange patient positions with each other directly. However, the study-owning location can retrieve patient positions from one sharing location and then reassign those patients to another sharing location.

• The study-owning location can delete a patient position if it owns the patient position and if no data has been entered for the patient.

• After randomized patient positions have been replicated, you cannot re-randomize them, but you can expand the randomization. After a randomized study has been replicated, you cannot re-randomize the study.

Exceptions for Study Design Activities

The study-owning location can perform all study design activities. Sharing locations can perform only the following study design activities:

• Assign sites and investigators to the study

• Assign patients owned by that sharing location to study sites

• Break the blind for a patient

• Maintain personal details for a patient

These activities are managed by the owning location of the patient position. This location may be a sharing location or the study-owning location, depending on which one owns the patient position.

Replicating Data at a Study-Owning Location

The study-owning location is the only location that can replicate study data directly from all sharing locations. As the study data repository, the study-owning location must schedule replications of data from the sharing locations for the study.

The sharing locations can replicate only from the study-owning location. So, at any point in the conduct of the study, the sharing locations have available to them only the data replicated by the study-owning location from the various sharing locations, plus the data collected at the study-owning location itself.

As a study-owning location, if you receive study data from a lab owned by another location, you must replicate that lab and its ranges into your database.