4 Managing Trials

This chapter contains the following sections:

Section 4.1, "Viewing the List of Trials"
Section 4.2, "Creating Trials"
Section 4.3, "Viewing and Modifying Trial Details"
Section 4.4, "Viewing and Resolving Duplicate Items"
Section 4.5, "Bulk Copying"
Section 4.6, "Selective Copying"
Section 4.7, "Archiving Trials"
Section 4.8, "Viewing Archived Trials"
Section 4.9, "Exporting Trial Details"
Section 4.10, "Exporting Trials"
Section 4.11, "Importing Trials"
Section 4.12, "Generating InForm XML"

4.1 Viewing the List of Trials

The List of Trials page lets you view the list of trials and their details. It also lets you filter the trials based on the filter criteria.

To view the list of trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
To filter trials, enter the filter criteria in the filter section and click Find. The list of trials that satisfy the specified filter criteria is displayed.

When you specify the filter criteria, you can use the full name or part of the name.

For more details on how to filter and view trials, see Section A.66.
To clear the filter criteria, click Clear.

Note:

To navigate through the trial list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the trials on a single page, select All from the drop-down list.

Click the column name link to sort the trials in the ascending or descending order, based on the column name. On the first click, the trials are sorted in the ascending order. To sort the trials in descending order, click the column name link again.

4.2 Creating Trials

The Create Trial Details page lets you create a main trial, training trial, and UAT trial. Enter the trial and association details to create a trial. You can also copy the sites, roles, groups, and configuration settings from another trial. You cannot create production trials.

To create trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the Create Trial link. The Create Trial Details page is displayed.
Enter the trial details.

For more details on how to create trials, see Section A.41.
To copy the details of an existing trial, click Copy From. In the confirmation dialog box that appears, click OK to continue. In the pop-up window that appears, select the sites, roles, groups, users, and configuration that you want to copy and click Copy.
Click Submit to save the trial details.

Note:
To save the current trial details and create another trial, click Submit and Add Another.
To discard the changes, click Cancel.

4.3 Viewing and Modifying Trial Details

The Trial Details page lets you view and modify the trial details. If the trial details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify trial details:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the trial name link in the grid. The Trial Details page is displayed, which shows the selected trial details.
Modify the trial details.

For more details on how to modify trial details, see Section A.41.

Note:
If you modify the current sponsor company displayed in the Current Sponsor Company drop-down list, the List of Trials page is displayed.
Enter the reason for modifying the trial details in the Reason for Change text box and click Save.
To cancel the changes made to the trial details, click Cancel.
To view the list of audit trails for a particular field, click the corresponding icon.

4.4 Viewing and Resolving Duplicate Items

When you import trials, records or trial items may be duplicated. The List of Duplicate Items page displays the list of duplicate items and lets you resolve the duplicate trial items.

To view and resolve duplicate items:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the icon corresponding to a trial.

The List of Duplicate Items page is displayed, which shows the list of duplicate trial items.
Select the check box corresponding to the item you want to resolve and click Resolve.
On the confirmation dialog box that appears, select OK. All unchecked items are deleted.

4.5 Bulk Copying

You can copy all or selected modules entirely (such as sites, users, and so on) from a trial to another.

To bulk copy trial details:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the icon corresponding to a trial.
On the page that appears, click the Bulk Copy link. The Bulk Copy page is displayed.

For more details on selective trials copy, see Section A.22.
Select the source trial from the Source Trial drop-down list.
Select the check boxes of the modules you want to copy.
Click Submit to create a copy of the trial.

4.6 Selective Copying

You can selectively copy trial details from a module onto another trial.

To copy selective trial details:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the icon corresponding to a trial. The Selective Copy page is displayed.
Select the source trial and type of detail from the Source Trial and Select Type drop-down lists. The Selective Copy page displays the details according to the selected type in the Available text box.

For more details on selective trials copy, see Section A.29.

Note:
Depending on the details type you select from the Select Type drop-down list, the User Management Tool gives you an option to copy additional details. For instance, if you select Roles, you can copy the details of all associated sponsor users and associated site users, in addition to the regular details of the roles.
Use >> or > to move all or selected details to the Selected field.

Note:
Press and hold the Ctrl key to select multiple choices.
Use the << or < button to move all or selected details back to the Available field.
Click Submit to create a copy of the trial.

4.7 Archiving Trials

The Archive option available on the List of Trials page lets you archive inactive trials.

To archive trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Select the check box corresponding to the trial you want to archive.
Select Archive from the Select drop-down list.
Enter the reason for archival in the Comments text box and click Go.
To view the archived sponsors, click the View Archive of Trials link.

4.8 Viewing Archived Trials

The List of Archived Trials page lets you view the archived trials. You can view the trial name, reference, protocol number, therapeutic area, and status. This page also displays the date and time of archival.

To view archived trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click the Archived Trials link. The List of Archived Trials page is displayed, which shows the list of archived trials.

For more details on archived trials, see Section A.67.

Note:

To navigate through the trial list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the trials on a single page, select All from the drop-down list.

To go back to the list of trials, click Back.

4.9 Exporting Trial Details

The Export to Excel and Export to File links available on the List of Trials page let you export trial details. You can export the trial details either to an Excel spreadsheet or to a flat file.

To export trial details:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Select the check box corresponding to the trial you want to export.
Click the Export to Excel or Export to File link. On the dialog box that appears, click Open to open the file or click Save to save the file.

4.10 Exporting Trials

Clicking Export on the List of Trials page lets you export trials and their associated sites, site users, sponsor users, roles, and groups.

To export trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click Export. The Export page is displayed.
Select the trial name from the Trial Name drop-down list.
Select the modules to be exported by clicking the corresponding check boxes.
Click the Export to Excel or Export to File links to export the file to an Excel spreadsheet or to a flat file or Export IRT CSV (which exports only the IRT trial in CSV format).
To cancel the export, click Return.

4.11 Importing Trials

Clicking Import on the List of Trials page lets you import trial details and their associated sites, site users, sponsor users, roles, and groups. This facility is available only to users having the Import Data right.

To import trials:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Click Import. The Import page is displayed.
Enter the path of the file in the Filename text box or click Browse to select the path of the file.

Note:
The selected path is copied in the Filename text box.
Select the trial name from the Trial Name drop-down list.
Select the modules to be imported by clicking the corresponding check boxes.
Select the import template from the Excel Template For All Products and Version drop-down list.

Note:
Composite Template is the default import template.
Click Validate and Import.
To cancel import, click Cancel.

For Import Error Information and Trouble shooting, see Section A.47.

4.12 Generating InForm XML

You can export the details of a trial to an XML file. However, you can export the details of only one trial to an XML file at a time.

To generate InForm XML:

Select Trials from the menu bar. The List of Trials page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.
Select the check box corresponding to the trial you want to generate.
Click the Generate InFormXML link. On the dialog box that appears, click Open to open the file or click Save to save the file.