Creating Risk Assessment Templates

A Risk Assessment and Categorization Tool (RACT) template for the Clinical level of risk assessment is available in the preconfigured Siebel Clinical application. Administrators select a level (or type) of risk assessment in the Type field when they create an assessment template. They can create additional assessment templates with associated attributes using the RACT Templates view of the Administration - Clinical screen.

To create a risk assessment template

1. Navigate to the Administration - Clinical screen, then the RACT Templates view.

2. In the RACT Templates list, create a new record and complete the necessary fields as shown in the following table.

   Field	Comments
   Assessment	Type in the name of the template.
   Type	Select a value that specifies the type of risk assessment template, which can be one of the following: Clinical Clinical Program Clinical Protocol Clinical Protocol Site Clinical Region
   Active	Select this check box to indicate that the risk assessment template is active, otherwise clear the check box.
   Description	Type in a description of the risk assessment template.

3. In the Assessment Questions list, create a new record for each question you want to assess and complete the necessary fields as shown in the following table.

   Field	Comments
   Order	Enter the order number for the assessment question.
   Category	(Mandatory field) Select a category for the assessment question, which can be one of the following: Safety Study Phase Complexity Subject Population Technology Data Collection, CRF source Endpoints Organization Experience Investigational Product/Study Medication IP Logistics/Supply Chain Blinding Operational Complexity Geography
   Questions	Type in the assessment question.
   Weight	Type in the weight for the assessment question. The default value is 1.
   Considerations	Type in any additional information relevant to the assessment question that should also be considered. Any information that you enter in this field automatically appears on screen (for example, as a tool tip) when the user places the mouse over the respective question during an assessment.

4. In the Question Values list, create records to further describe the assessment questions you created in the previous step, and complete the necessary fields as shown in the following table.

   Field	Comments
   Order	Enter the order number that corresponds to the assessment question.
   Type	Select from the following values to describe the assessmenquestion: Impact Probability Detectability
   Value	Select the value that applies to the option that you select in the Type field. For Impact and Probability, the values available are: High (3) Medium (2) Low (1) For Detectability, the values available are: Difficult to detect 3) Medium to detect (2) Easy to detect (1)
   Score	Enter the score for the value that you select.