Risk Assessments for Clinical Trials

You can create risk assessment templates and 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

For more information, see "Creating Risk Assessment Templates" and "Performing Risk Assessments for Clinical Trials".

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.

   Some fields are described 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.

   Some fields are described 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 Step 3, and complete the necessary fields.

   Some fields are described 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 assessment question: 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.

   
   

Performing Risk Assessments for Clinical Trials

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 Clinical Programs screen, then the Program List view and drill down on the Program field of the clinical program that you want to assess.

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

   • To perform a risk assessment of a clinical region, navigate to the Regions 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 # field of the site that you want to assess.

2. Navigate to the RACT 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 Questions list, enter a value for each question to assess the program, protocol, region, or site in the clinical trial.

   Some fields are described in the following table.

   Field	Comments
   Order	(Read-only) Displays the order number for the question when you save the assessment template record. Administrators set up the order number for each question when they set up the template.
   Category	(Read-only) Displays the category for the question, such as Safety, Technology, Operational Complexity, and so on.
   Questions	(Read-only) Displays the assessment question when you save the assessment template record. Administrators set up questions when they set up the template.
   Impact	Select an impact value for the question, which can be one of the following: High (3) Medium (2) Low (1) This value determines the impact of the individual risk on the trial.
   Probability	Select a probability value for the question, which can be one of the following: High (3) Medium (2) Low (1) This value determines the probability of occurrence of the individual risk.
   Detectability	Select a detectability value for the question, which can be one of the following: Difficult to detect 3) Medium to detect (2) Easy to detect (1) The higher the detectability of individual risk, the lower the overall risk to the trial
   Weight	(Read-only) 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. This field is essentially ranks the importance of the category. If all categories have a default value of 1.0, then all categories are of equal importance.
   Risk Score	(Read-only) Displays the risk assessment score for the individual question. Individual risk scores are calculated automatically from the values in the following fields: Impact, Probability, Detectability, Weight. The default formula for calculating individual risk score is product of Impact, Probability, Detectability and Weight.
   Risk Level	Select a value that specifies the type of risk assessment template, which can be one of the following: Program Protocol Program/Protocol
   Rationale	If required, type in any explanatory information to capture the rationale for category risk level assessment.
   Functional Impact	Select a functional impact value for the attribute, which can be one of the following: Medical Monitoring Plan Safety Plan Data Plan Statistical Analysis Plan Monitoring Plan Training Plan Quality Plan Risk Management Log Communication Plan This field highlights the specific functional plans that might be impacted by this assessment.
   Mitigation	If required, type in the mitigation actions or plans for categories with the highest category risk score.