Copying Clinical Studies

You can copy the details of a clinical study. This is limited to the Clinical Studies, Clinical Study Enrollment Criteria, Clinical Study Termination Criteria, Study Comments, Clinical Study History, and Study Regions tables. The copying function does not copy the Study Design. Use the Copy a Clinical Study Version function to copy the actual Design.

This utility is useful for importing the attributes of an existing study into a new study. Use this utility to reduce the effort required to design a new study when a similarly structured study already exists. This differs from copying a study version, where the system copies all attributes of another version exactly as is, including randomization. Before you can copy the attributes of one study to another, the target study must--at least--be at the planned level of development.

Select or query the record you want. You cannot insert, delete, or update in this window. Click the Copy Study button to view the Copy Study window, where you specify information about the new study.

1. From the Design menu, select Studies, then choose Copy Clinical Studies. The Clinical Studies window opens, listing only the studies available for copying attributes.
2. Enter—or query—the study code for the study to copy.
3. Click the Copy Study button.
4. Use the list function to choose a target study--the study to acquire the attributes of the study you selected in the previous window. Note: There is no recourse from the following step. Cancel if you are not certain you are selecting the correct target study.

For more information, see:

• Replicating Clinical Studies
  
• Creating Study Versions
  

Replicating Clinical Studies

A clinical study can be replicated from one location to another. Only one location can maintain a study design but other locations can have read-only copies. Use this function to replicate a study design from its owning location to yourself. See the "Distributed study conduct" chapter in the Oracle Clinical Administrator's Guide for more information about replication.

To replicate clinical studies, from the Design menu, select Studies, and choose Replicate Clinical Study for the Replicate a Clinical Study window. The system stores information from this form in many tables, including Clinical Studies, Clinical Study Objectives, Clinical Study Enrollment Criteria, and Clinical Study Versions. Select the record you want by entering the requested codes. The fields are list-enabled.

Creating Study Versions

A study typically passes through several iterations of refinement and can have several potential designs, depending on the parameters included in its protocol. These iterations of refinement can be modeled in Oracle Clinical as clinical study versions, each of which may be thought of as a potential protocol. The attributes that affect the design are held at the version level. When the protocol is finalized, you choose one of these versions to be the "live" version. Once live, you cannot change it or any other version of the study back to "not live." However, the live version can still be modified and developed.

Note:

RDC does not work with studies that have multiple study versions. Errors include (but are not limited to):

• selecting and using a patient when a patient with the same patient code exists in two or more study versions
• selecting and using a clinical planned event when a clinical planned event with the same name exists in two or more study versions

  To use RDC for a versioned study, delete the clinical study versions that are not live: Delete any associated items (such as patient positions and clinical planned events), associated with the clinical study version.

Setting the live flag on a study makes that version the one to use throughout the study. The study timeline, treatment patterns, stratification, and randomization can all be defined separately for each version of the study design.

From the Design menu, select Studies, then select Study Versions. The Maintain a Clinical Study Version window appears, listing all current clinical study versions appropriate for your privileges. The system displays the clinical study and version, if any, of your current session. You can select another, and you can query to modify the list.

For more information, see:

• Copy Logic for Clinical Study Versions
  

Copy Logic for Clinical Study Versions

Oracle Clinical's copy logic distinguishes between copying a clinical study version within a clinical study and copying from one clinical study to another. When you copy a version within a study, you are usually creating a new version, a checkpoint in the study design process, or recording a change to the protocol. Oracle Clinical produces an exact copy of all attributes of the version, including randomization.

However, when you copy a version from one study to another, you are usually designing a new study. For this reason, Oracle Clinical performs the copy so that it looks as if the data is new. The system resets the creation user and timestamp to the current user and date, and the modified user and timestamp values are set to null. The system also sets the blinded attributes of a randomization to their default values.