Performing Risk Assessments for Clinical Trials

You can perform risk assessments for clinical trials at the following levels:

• Clinical (for generic assessment of a program, protocol, region, or protocol site)

• Clinical Program

• Clinical Protocol

• Clinical Region

• Clinical Protocol Site

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 Sales Assessment Templates view of the Administration - Data screen. For more information about creating assessment templates, see Siebel Applications Administration Guide.

To perform a risk assessment for a clinical trial, you select an appropriate risk assessment template for a program, protocol, region, or site in that clinical trial. This template facilitates uniformity in the assessment process.

After you save the selected risk assessment template, a list of attributes that you must evaluate appears in the Assessment Attributes list. Attributes are frequently questions that you answer to evaluate the risk of adverse outcomes or the integrity of data for the program, protocol, region, or site. To evaluate an attribute, you enter an appropriate value for the attribute. In the Assessment Attributes list, you cannot add attributes to or delete attributes from the risk assessment template.

To perform a risk assessment for a clinical trail 

1. Complete one of the following steps:

   • To perform a risk assessment of a clinical program, navigate to the Administration - Clinical screen, then the Program List view, and drill down on the Program field of the program that you want to assess.

   • To perform a risk assessment of a clinical protocol, navigate to the Administration - Clinical screen, then the Protocol List view, and drill down on the protocol number field of the protocol that you want to assess.

   • To perform a risk assessment of a clinical region, navigate to the Administration - Clinical screen, then the Region List view, and drill down on the Region field of the region that you want to assess.

   • To perform a risk assessment of a site, navigate to the Site Management screen, then the Protocol Site List view, and drill down on the site number field of the site that you want to assess.

2. Navigate to the Assessment view.

3. In the Assessment Templates list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Name	When you save the record, displays the name of the template that you select followed by an automatically generated number that uniquely identifies the assessment, but you can change this name.
   Template Name	Select a template that includes the appropriate attributes to assess the program, protocol, region, or site.
   Description	Displays the description of the template that you select.
   Updated	Displays the date and time that you last updated the record.
   Score	Displays the sum of the Weight field multiplied by the Score field for the assessment attributes that are associated with the template. This field is populated after you assign values to assessment attributes.
   Percent	Displays as a percentage the result of the Score field for the template divided by the Maximum Score field for the template. This field is populated after you assign values to assessment attributes.
   Maximum Score	Displays the highest score possible for the template that you select. For each assessment attribute in the template, the Weight field is multiplied by the highest value possible in the Score field. The sum of these results is the maximum score for the template.

   
   

4. In the Assessment Attributes list, enter a value for each attribute to assess the program, protocol, region, or site in the clinical trial.

   Some fields are described in the following table.

   Field	Comments
   Order #	Displays the order number for the attribute when you save the assessment template record. Administrators set up the order number for each attribute when they set up the template.
   Attribute Name	Displays the attribute name when you save the assessment template record. Administrators set up the name for each attribute when they set up the template.
   Value	Select the value that is applicable to the attribute name.
   Comment	Type more information about the Value field, if necessary.
   Weight	Displays the weight for the attribute when you save the assessment template record. Administrators set up the weight for each attribute when they set up the template.
   Score	Displays the score for the value that you select. Administrators set up the score for each value when they set up the template.