Maintaining Investigator Records

As with sites, you can create general records to represent the Investigators who are responsible for collecting data at the sites in any study.

For more information, see:

• Creating Investigator Records
  
• Assigning Investigators to Study Sites
  

Creating Investigator Records

To create and maintain an Investigator record, work in the Maintain Investigators window. From the Design menu, select Investigators and Sites, then choose Investigators. In the Investigators window you can create, update, or delete Investigator records. See the next section for assigning an Investigator to a study site—a site assigned to a particular study.

Note:

If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to define Investigators. The definitions are populated automatically from Siebel Clinical.

Assigning Investigators to Study Sites

Note:

If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to assign Investigators to study sites. The assignment is imported automatically from Siebel Clinical.

A study site has exactly one Investigator in charge; however, that assignment can change over time, and a single Investigator might be responsible for several sites. To assign an Investigator to a site:

1. From the Design menu, select Investigators and Sites, then choose Study Sites. The system displays all sites associated with the selected study.
2. Select a site.
3. Click the Assignments button. The system displays a history of Investigator assignments to the selected site, if any. Use the list function to select an Investigator record.
4. Enter an Investigator code. You can use the list function to locate a particular Investigator.
5. Enter information regarding the assignment like start and end dates, and the number of patients required.
6. Save. The system designates the new Investigator as current, removing that designation from the Investigator previously in that position.

To view details about a particular Investigator, click the Investigator Details button. (See Creating Investigator Records for more information).