Managing Clinical Training

This chapter covers how to manage clinical training. It includes the following topics:

About Managing Clinical Training

Clinical Trials involve personnel at multiple sites. Companies and CROs (clinical research organizations) that conduct clinical trials must train and certify these people about those trials. This education is an important aspect of risk based monitoring and helps companies and CROs to reduce monitoring costs and expedite the clinical trail process. Companies and CROs are responsible for making sure that site personnel understand:

The ethical aspects of research involving human subjects.
The rules and regulations of regulatory agencies.
Their roles and responsibilities in clinical trials.
The appropriate SOPs (standard operating procedures) and work instructions for clinical trials.
The various aspects of clinical trials, such as their clinical indications.

As part of the planning for clinical trials, administrators create training plans to manage the training of personnel. These training plans include training topics. Users can then track these training topics for themselves and close the topics when they complete them. This tracking provides an audit record of the training for regulatory agencies.

Setting Up Training Topics for Clinical Training

Administrators set up training topics for clinical training so that they can associate the topics with versions of training plans. For more information about associating topics with versions of training plans, see Creating Versions of Training Plans.

Administrators can associate a single topic with multiple training plans. Also, users can manually add to sites the training topics that administrators create. For more information, see Changing Training Topics for Clinical Sites.

After you publish a version of a training plan with associated topics, you cannot change the field values (except for the value in the Obsolete Date field) for those topics in the Training Topics view of the Administration - Clinical screen. If you change the field values for a topic in the Training Topics view of the Administration - Clinical screen after you associate the topic with an unpublished version of a training plan, then the changed values are reflected in the topic for that version of the training plan.

To set up a training topic for clinical training

Navigate to the Administration - Clinical screen, then the Training Topics view.

In the Training Topics list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Name	Type the name of the training topic.
Category	Select the type of training applicable to the training topic.
Role	Select the roles of the users who must complete the training topic. To select a role, click the select button in the field to open the Contact Roles dialog box, click New (the plus (+) icon) to select the Role field in the dialog box, and then select a value from the drop-down list for the Role field. Click OK after you select all of the appropriate roles for the training topic. If you do not select any roles, then all contacts for the clinical sites that are associated with the topic must complete the topic.
Description	Type a description of the training topic.
Mandatory	Select this field to indicate that completing the training topic is mandatory.
Duration	Type an estimate of the numeric value for the time that is needed to complete the training topic.
Duration Unit	Select the units of time that apply to the numeric value that you enter in the Duration field.
Created Date	Displays the date and time that you create the training topic.
Obsolete Date	Select the date and time that the training topic is inactive. If you populate this field for a topic after publication of a training plan that contains this topic, then the topic is deleted from the site to which it is published. Before you can delete a topic, you must populate this field for the topic and then save the topic record. You can delete only the topics that are not yet associated with published plans. If you want to indicate that the training topic is again active, then clear this field. You cannot add an obsolete training topic to a training plan. If you add a training topic to a training plan before the topic is obsolete, then the topic remains on the training plan.

Creating Training Plans

Administrators create training plans and then designate the criteria for those plans and the training topics for versions of those plans. For more information about designating the criteria, see Adding Criteria to Training Plans. For more information about designating the training topics for versions, see Creating Versions of Training Plans.

When administrators publish the plans, the training topics in those plans are automatically associated with the appropriate contacts for the appropriate sites. The Role field value for the training topics in the plans determines the appropriate contacts. The plan criteria determines the appropriate sites.

To create a training plan

Navigate to the Administration - Clinical screen, then the Training Plans view.

In the Training Plans list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Name	Type the name of the training plan.
Description	Type a description of the training plan.
Version Number	Displays the number for the version of the training plan when you select a value of Approved in the Status field for that version, and then save the version record. For more information, see Creating Versions of Training Plans.
Process Status	Displays the status of the publishing process for the training plan as follows: When you create a new record for a training plan, this field value defaults to Not Started. When you click the Publish button to publish the training plan, this field value changes from Not Started to Publishing. After publishing is complete, and publishing is unsuccessful, this field value changes from Publishing to Failed. After publishing is complete, and publishing is successful, this field value changes from Publishing to Published. When you select a value of Approved in the Status field for a new version (but not the first version) of the training plan, and then save the version record, this field value changes from Published to Not Started.
Created Date	Displays the date and time that you create the training plan.
Obsolete Date	Select the date and time that the training plan is inactive. After you populate this field and then save the plan record, you cannot change the field values for the training plan, the criteria for the training plan, or the versions for the training plan. You cannot delete training plans. If you want to indicate that the training plan is again active, then clear this field. After the training plan is again active, you can change it.
Sites Processed/ Total Sites	Displays the number of sites that the publishing process associated with the training plan (sites processed) compared to the number of sites that apply to the training plan (total sites). This field is automatically populated when you publish the training plan. If you successfully publish the training plan, then the number of processed sites equals the number of total sites. If you fail to successfully publish the training plan, then the number of processed sites is not equal to the number of total sites. If you create a new approved version of the training plan, then this field value is cleared.
% Completed	Displays the fraction in the Sites Processed/Total Sites field as a percentage. This field is automatically populated when you publish the training plan. If you successfully publish the training plan, then this field value is 100%. If you fail to successfully publish the training plan, then this field value is less than 100%. If you create a new approved version of the training plan, then this field value is cleared.
Publish Result	Displays the final result of the process to publish the training plan. If you create a new approved version of the training plan, then this field value is cleared.

Adding Criteria to Training Plans

Administrators add criteria to training plans to designate the sites to which the plans apply. When they publish the training plans, the appropriate contacts for these sites are automatically associated with the training topics in those plans. The Role field value for the training topics in the plans determines the appropriate contacts. Also, users can manually add training plans to sites. For more information, see Adding Training Plans to Clinical Sites.

After you publish a version of a training plan, you cannot change or delete the criteria for that training plan.

To add criteria to a training plan

Navigate to the Administration - Clinical screen, then the Training Plans view.
Drill down on the Name field of the training plan for which you want to add criteria.
Navigate to the Criteria view.

In the Training Plan Criteria list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Scope	Select the scope of the training plan as follows: If you select a value of All, then the training plan applies to all sites in Siebel Clinical, and you cannot enter values in the other fields of the Training Plan Criteria list. You cannot create more criteria records for the training plan. If you select a value of Specific, then the training plan applies to specific sites in Siebel Clinical, and you designate these sites in the other fields of the Training Plan Criteria list. You can create more criteria records for the training plan.
Indication	Select the clinical indication that applies to the training plan.
Trial Phase	Select the trial phase that applies to the training plan.
Site Status	Select the site status that applies to the training plan.
Protocol #	Select the protocol number that applies to the training plan. The values that you select for the indication and trial phase determine the values that are available to you for selection in this field. If you select a protocol number and subsequently select a value for an indication or a trial phase that is not associated with that protocol number, then the criteria record that you create has no effect because no protocols meet the criteria.
Region	Select the region that applies to the training plan. The value that you select for the protocol number determines that values that are available to you for selection in this field.

If necessary, create more new records in the Training Plan Criteria list to add more criteria to the training plan.

Creating Versions of Training Plans

Administrators create versions of training plans so that they can associate training topics with those plans. As business needs change over time, they can create new versions of training plans to accommodate those needs.

After you publish a version of a training plan, you cannot change the data in that version. For example, you cannot add training topics to or delete training topics from that version. If you want to change the data in an existing training plan, then you must create a new version of the plan, and publish the plan again.

After you publish a version of a training plan, you cannot delete that version.

To create a version of a training plan

Navigate to the Administration - Clinical screen, then the Training Plans view.
Drill down on the Name field of the training plan for which you want to create a version.
Navigate to the Versions view.

In the Versions list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Version Number	Displays an automatically generated version number. The first version record that you create is automatically populated with a version number of 1, the second version record that you create is automatically populated with a version number of 2, and so on.
Name	Type the name of the version of the training plan.
Status	Select a value of Approved in this field to indicate that this version is the approved version of the training plan. Only one version of a training plan can have an approved status. You must select the Approved value and then save the version record before you can publish the training plan. You are not allowed to select the Approved value until you add at least one training topic to the version. For more information about adding training topics to a version, see Step 5. In addition, this field displays an automatically generated value for the status of the version as follows: When you create a new version record, this field value defaults to Draft. When you click the Publish button to publish the training plan for this version record, this field value does not change from Approved. When you select the Approved value in this field for another version record in the training plan, this field value changes from Approved to Archived for this version record.
Comments	Type appropriate comments about the version of the training plan.
Created Date	Displays the date and time that you create the version of the training plan.
Published Date	Displays the date and time that you publish the version of the training plan.
Archived Date	Displays the date and time that you archive the version of the training plan.

Complete the following steps to select the training topics for the version:
1. In the Training Topics list, click Add Topics.
2. In the Training Topics dialog box that appears, select the training topics for the version.
  To select multiple topics, hold down the CTRL key and click each topic record. Topics that have a value in the Obsolete Date field are not available for selection. For information about setting up the training topics that appear in this dialog box, see Setting Up Training Topics for Clinical Training.
3. Click OK.
  The selected topics appear in the Training Topics list. You cannot change the field values in these selected topic records. However, you can delete the topic for which you want to change the field values, change the field values for the topic in the Training Topics view of the Administration - Clinical screen (if the topic is not associated with another published training plan), and then add the changed topic to the version again.

About Publishing Training Plans

After administrators create training plans, they publish the training plans so that the training topics in those plans are automatically associated with the appropriate contacts for the appropriate sites. The Role field value for the training topics in the plans determines the appropriate contacts. The plan criteria determines the appropriate sites.

The publishing process for a training plan is a batch job that runs in the background. Consequently, users are not prevented from using other functionality in Siebel Clinical while this batch job runs. To optimally run this batch job, administrators can set the Clinical_Training_Commit_Freq system preference. For more information about this system preference, see System Preferences in Siebel Clinical.

The duration of the publishing process for a training plan is determined by the following factors:

The number of training topics in the plan
The number of site records to associate with the training topics in the plan
The number of contact records to associate with the training topics in the plan

When a user creates a site record after an administrator publishes a training plan that applies to that site, the topics in that plan are automatically associated with the new site. Likewise, the topics in that plan are automatically associated with the contacts for the new site if the Role field in the topics is blank or a Role field value in the topics is the same as the Role field value in the contact records. If the administrator populates the Obsolete Date field (in the Training Topics view of the Administration - Clinical screen) for some topics in a plan after the plan publication, then those topics are not automatically associated with a new site even though the topics exist in the training plan.

When a user creates a new contact record for an existing site after an administrator publishes a training plan that applies to that site, the topics in that plan are automatically associated with the new contact if the Role field in the topics is blank or a Role field value in the topics is the same as the Role field value in the new contact record. If the administrator populates the Obsolete Date field (in the Training Topics view of the Administration - Clinical screen) for some topics in a plan after the plan publication, then those topics are not automatically associated with a new contact even though the topics exist in the training plan.

Publishing Training Plans

Administrators can publish only training plans that have a version with a Status field value of Approved. Also, users can manually add to sites the training plans that administrators publish. During the process to publish a training plan, no one can change any of the data associated with that plan. For more information, see About Publishing Training Plans.

If the publishing process is unsuccessful, then possibly the server is not operating. For more information about unsuccessful publishing processes, contact your system administrator.

To publish a training plan

Navigate to the Administration - Clinical screen, then the Training Plans view.
Drill down on the Name field of the training plan that you want to publish.
If necessary, change the Status field for the version of the plan from Draft to Approved, and save the version record.
Click Publish.
The publishing process is initiated, and the value in the Process Status field for the training plan changes from Not Started to Publishing.
Navigate back to the Administration - Clinical screen, then the Training Plans view to see the final status of the publishing process.
After the process is complete, the Process Status field changes to Published if the process is successful or to Failed if the process is unsuccessful.

Adding Training Plans to Clinical Sites

When administrators publish training plans, the training topics in those plans are automatically associated with the clinical sites that meet the criteria in the plans. When a clinical site does not meet the criteria in a training plan, but the training plan applies to the site, you can manually add the training plan to the site. When you manually add a training plan to a site, its associated training topics are automatically added to the site. However, if the administrator populates the Obsolete Date field (in the Training Topics view of the Administration - Clinical screen) for some topics in that plan, then those topics are not automatically added to the site even though the topics exist in the training plan.

The contacts for a clinical site are automatically associated with the training topics in the training plans that you add to the site if a Role field value in the topics is the same as the Role field value in the contact records. If the Role field in a topic of an added plan has no value, then all of the contacts for the clinical site are automatically associated with that topic.

You can add to clinical sites only the versions of training plans for which:

The Obsolete Date field of the training plan has no value.
The Status field for the version of the training plan has a value of Approved.

To add training plans to a clinical site

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to add training plans.
Navigate to the Training view.
To add training plans, complete the following steps:
1. Click Add Plans.
2. In the Training Plans dialog box that appears, select the training plans to add.
  To select multiple plans, hold down the CTRL key and click each plan record. For information about setting up the training plans that appear in this dialog box, see Creating Training Plans.
3. Click OK.
  The training topics associated with the selected training plans appear in the Site Training Status list.

Changing Training Topics for Clinical Sites

When administrators publish training plans, the training topics in those plans are automatically associated with the clinical sites that meet the criteria in the plans. When additional training topics apply to a site, you can manually add these topics to the automatically-added topics.

The contacts for a clinical site are automatically associated with the training topics that you add to the site if a Role field value in the topics is the same as the Role field value in the contact records. If the Role field in an added topic has no value, then all of the contacts for the clinical site are automatically associated with that topic.

You can add to clinical sites only the training topics for which the Obsolete Date field of the training topic has no value.

When training topics no longer apply to a site, you can delete the topics if the Mandatory field is not selected for the topics. You cannot change the field values in training topic records for clinical sites.

To change training topics for a clinical site

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to change training topics.
Navigate to the Training view.
To add training topics, complete the following steps:
1. Click Add Topics.
2. In the Training Topics dialog box that appears, select the training topics to add.
  To select multiple topics, hold down the CTRL key and click each topic record. For information about setting up the training topics that appear in this dialog box, see Setting Up Training Topics for Clinical Training.
3. Click OK.
  The selected topics appear in the Site Training Status list.
To delete a training topic, select the topic in the Site Training Status list, and delete it.

Designating Completed Training for Training Topics

In Siebel Clinical, you can access the training topics for clinical sites, and then designate when the contacts who are associated with those topics complete those topics. A contact is associated with only the topics that have no value in the Role field or a Role field value that is the same as the Role field value in the contact record. If you change the Role field value for a contact after the contact is associated with training topics, then the incomplete training topics for the contact can automatically change to accommodate the new role.

To designate completed training for training topics

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to designate completed training for training topics.
Navigate to the Training view.
In the Site Training Status list, select the appropriate training topic.
Complete one of the following steps:
- If you want to designate that training is complete for all contacts associated with the training topic, then in the Site Training Status list click Complete All.
  In the Site Training Status list, the Contacts Completed field and the Contacts Not Completed field are automatically updated for the training topic. Also, for all contacts in the Contacts list, the Completed field is selected and the Completed Date field is populated with the current date and time.
- If you want to designate that training is complete for selected contacts associated with the training topic, then in the Contacts list select the Completed field for those contacts.
  In the Site Training Status list, the Contacts Completed field and the Contacts Not Completed field are automatically updated for the training topic. Also, in the Contacts list, the Completed Date field is populated with the current date and time for those contacts for which you select the Completed field and save the contact record.
If you want to reverse your designation of completed training for a contact, then clear the Completed field for the contact.
(Optional) In the Contacts list, complete the following steps for the appropriate contacts:
1. Enter comments about the completed training.
2. Change the value in the Completed Date field from the date and time when you designate that training is complete to the date and time that the contact actually completed the training.

Designating Completed Training for Contacts

In Siebel Clinical, you can access the contacts for clinical sites, and then designate when the contacts complete the training topics assigned to them. A contact is associated with only the topics that have no value in the Role field or a Role field value that is the same as the Role field value in the contact record. If you change the Role field value for a contact after the contact is associated with training topics, then the incomplete training topics for the contact can automatically change to accommodate the new role.

To designate completed training for contacts

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to designate completed training for contacts.
Navigate to the Contacts view.
In Contacts list, select the appropriate contact.
Complete one of the following steps:
- If you want to designate that training is complete for all training topics associated with the contact, then in the Training Topics list click Complete All.
  In the Contacts list, the Trainings Completed field is automatically updated to show the number of training topics that the contact completed. Also, for all topics in the Training Topics list, the Completed field is selected and the Completed Date field is populated with the current date and time.
- If you want to designate that training is complete for selected training topics associated with the contact, then in the Training Topics list select the Completed field for those training topics.
  In the Contacts list, the Trainings Completed field is automatically updated to show the number of training topics that the contact completed. Also, in the Training Topics list, the Completed Date field is populated with the current date and time for those topics for which you select the Completed field and save the contact record.
- If you want to designate that training is complete for most training topics associated with the contact, then in the Training Topics list click Complete All, and clear the Completed field for the few training topics that the contact did not complete.
  In the Contacts list, the Trainings Completed field is automatically updated to show the number of training topics that the contact completed. Also, in the Training Topics list, the Completed Date field is populated with the current date and time for the topics in which the Completed field is selected.
(Optional) In the Training Topics list, complete the following steps for the appropriate training topics:
1. Enter comments about the completed training.
2. Change the value in the Completed Date field from the date and time when you designate that training is complete to the date and time that the contact actually completed the training.

Viewing Training Information for Clinical Protocols

When administrators publish training plans, the training topics in those plans are automatically associated with the clinical sites that meet the criteria in the plans. Each site is associated with a clinical protocol. When users designate completed training for the training topics or for the contacts of a clinical site, the training completion details are summarized and rolled up to the associated clinical protocol. Complete the procedure in this topic to view the progress of site training for a clinical protocol.

To view the training information for a clinical protocol

Navigate to the Protocols screen, then the Protocol List view.
In the Protocol list, drill down on the protocol number field of the protocol for which you want to view training information.
Navigate to the Training view.
Click Refresh to update the view with the latest information about completed training.

Review the training information in the training overview applet.

Some fields are described in the following table.

Field	Comments
Total Trainings	Displays the total number of training topics for the protocol. Each of these topics appears in the training details applet.
Trainings Completed	Displays the number of training topics that all associated contacts completed for all the sites in the protocol.
Sites Completed	Displays the number of sites in the protocol for which all associated contacts completed all the training topics.

Review the training information in the training details applet.

Some fields are described in the following table.

Field	Comments
Topic Name	Displays the training topic name for the protocol. If a topic associated with a site record for the protocol does not apply to any contacts for the protocol, then that topic does not appear in the training details applet.
Sites Completed	Displays the number of sites in the protocol for which all associated contacts completed the training topic.
Sites Not Completed	Displays the number of sites in the protocol for which all associated contacts have not completed the training topic.

Viewing Training Information for Clinical Regions

When administrators publish training plans, the training topics in those plans are automatically associated with the clinical sites that meet the criteria in the plans. Each site can be associated with a clinical region. When users designate completed training for the training topics or for the contacts of a clinical site, the training completion details are summarized and rolled up to the associated clinical region if such a region exists. Complete the procedure in this topic to view the progress of site training for a clinical region.

To view the training information for a clinical region

Navigate to the Regions screen, then the Region List view.
In the Region list, drill down on the Region field of the region for which you want to view training information.
Navigate to the Training view.
Click Refresh to update the view with the latest information about completed training.

Review the training information in the training overview applet.

Some fields are described in the following table.

Field	Comments
Total Trainings	Displays the total number of training topics for the region. Each of these topics appears in the training details applet.
Trainings Completed	Displays the number of training topics that all associated contacts completed for all the sites in the region.
Sites Completed	Displays the number of sites in the region for which all associated contacts completed all the training topics.

Review the training information in the training details applet.

Some fields are described in the following table.

Field	Comments
Topic Name	Displays the training topic name for the region. If a topic associated with a site record for the region does not apply to any contacts for the region, then that topic does not appear in the training details applet.
Sites Completed	Displays the number of sites in the region for which all associated contacts completed the training topic.
Sites Not Completed	Displays the number of sites in the region for which all associated contacts have not completed the training topic.