Operating from a Sharing Location

A sharing location takes its design and definition for the study from the study-owning location. It can conduct a study, but cannot modify the study design or definition. It can replicate, from the study-owning location, copies of data collected at other sharing locations for the study.

For more information , see:

• Study Design at a Sharing Location
  
• Study Definition at a Sharing Location
  
• Study Conduct at a Study-Sharing Location
  
• Data Replication at a Study-Sharing Location
  
• Replication of Labs and Lab Ranges at a Sharing Location
  
• Error if Flexible Study Setting Mismatch Between Locations
  

Study Design at a Sharing Location

Sharing locations receive their study design from the study-owning location. Every replication results in a fresh copy of the study design, including all new patient positions assigned to the sharing location.

A location that shares a study may also own studies itself. Every location can see the creation and maintenance screens in study design, however; a location cannot access studies it does not own via those screens, only via the query screens.

In general, a sharing location cannot modify the study design. However, a few exceptions to modifying the study design exist. At a sharing location, you can alter the study design as follows:

• You can:

  • Assign sites to the study

  • Assign investigators to study sites

  • Assign patients owned by your sharing location to the appropriate study site

  To perform any of these tasks, navigate to Design, Investigators and Sites, and then select Study Sites.

• You can locally disclose the treatment pattern assigned to a patient and create a blind break.

  To do this, navigate to Design, Randomization, Randomization Maintenance, and then select Disclose Patient Treatment Assignments.

• You can locally maintain patient details using either of the following options:

  • Navigate to Design, Patient Positions, and then select Patients.

  • Navigate to Data Entry, and then select Patient Enrollment.

• You can create and amend site plans for local study sites. To do this, navigate to Design, Studies, and then select Study and Site Plans.

Note:

When performing any of these study design activities at a sharing location, you see only the patient positions assigned to your location since the last time you replicated the study design.

Study Definition at a Sharing Location

The study-owning location defines all the core elements of a study—DCMs, DCM question groups, DCIs, and so on. A sharing location receives these definitions by replicating the study design and definition from the study-owning location. Study definition replicated from the study-owning location is available to view read-only from the study-sharing locations.

If the study-owning location changes any definitions, a study-sharing location must perform an incremental replication of the study definition. Once the study-sharing location completes the replication, Oracle Clinical ensures that all changes to the study definition are automatically applied to the study data during the next batch validation. The same automatic re-validation and re-derivation that occur at the study-owning location occur at each study-sharing location.

Note:

After the first full replication of a study definition at a study-sharing location, the study-sharing location must insert a record into the CLINICAL_STUDY_STATES table for the study-sharing location.

Study Conduct at a Study-Sharing Location

The study-sharing location can perform all study conduct activities, including:

• Log in documents for those patients that it owns.

• Do pass 1 entry, pass 2 entry, and update for its patients.

• Run Batch Validation against locally collected data.

• Do discrepancy management for locally collected data.

Data Replication at a Study-Sharing Location

At a study-sharing location, you can replicate study data from the study-owning location, but you cannot replicate study data directly from other sharing locations. Therefore, at any point in the conduct of a study, you have available only the data that the study-owning location has replicated from the various study-sharing locations, plus the data that the study-owning location has collected itself.

At a study-sharing location, when you replicate study data, you can elect to replicate the available data from one participating location (either another study-sharing location or the study-owning location) or from all participating locations (all study-sharing locations plus the study-owning location).

Replication of Labs and Lab Ranges at a Sharing Location

The options for replicating labs and lab ranges at a study-sharing location are the same as those at the study-owning location.

Error if Flexible Study Setting Mismatch Between Locations

The value of the Flex Study Enabled? setting at the source location must match the value of the Flex Study Enabled? setting at the target location. If a mismatch occurs, the replication job fails. Oracle Clinical reports the errors as follows:

• If a mismatch occurs during either a full or an incremental replication of a single study, the replication job completes with FAILURE. The output file contains the following error message:

  Error: Flex Study Enabled flags do not match between source and target for study: study_name

• When you submit a replication job, you can use the % wildcard character to replicate all studies. If a mismatch occurs during either a full or an incremental replication of multiple studies and if the mismatch occurs with more than one study, the replication job completes with SUCCESS. The failure text in the Batch Jobs window displays the following message:

  COMPLETED WITH WARNING DUE TO FLEXSTUDY FLAG MISMATCH

  In addition, the output file contains the following warning message:

  Warning: Flex Study Enabled flags do not match between source and target for one or more studies. Please check Clinical Study States form. The Job completed with Warnings.

• If a mismatch occurs during data replication of a study, the replication job completes with FAILURE. The output file contains the following error message:

  Error: Flex Study Enabled flags do not match between source and target for study: study_name

To resolve these issues:

1. Log in to Oracle Clinical at the source location.

2. Navigate to Conduct, Security, and then select Clinical Study States.

3. Verify the value of the Flex Study Enabled setting.

4. Update the value at each target location accordingly.

5. Save your changes.