| Oracle® User Management Tool User's Guide Release 12.0.1 E57087-01 |
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PDF · Mobi · ePub |
| Oracle® User Management Tool User's Guide Release 12.0.1 E57087-01 |
|
|
PDF · Mobi · ePub |
This chapter contains the following topics:
The List of Sites page lets you view the list of sites and site details. This page also lets you filter the sites based on the filter criteria.
To view the list of sites:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
To filter the sites, enter the filter criteria in the filter section and click Find. The list of sites that satisfy the specified filter criteria is displayed.
While specifying filter criteria, you can use the full name or part of the name.
For more details on how to filter and view sites, see Section A.31.
To clear the filter criteria, click Clear.
Note:
To navigate through the site 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 sites on a single page, select All from the drop-down list.
Click the column name link to sort the sites in the ascending or descending order, based on the column name. On the first click, the sites are sorted in the ascending order. To sort the sites in descending order, click the column name link again.
The Create Site Details page lets you create sites. Enter the site and user association details to create a new site.
To create sites:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Click the Create Site link. The Create Site Details page is displayed.
Enter the site and user association details.
For more details on how to create sites, see Section A.45.
Click Submit to save the details.
To save the current site details and create another site, click Submit and Add Another.
To discard the changes, click Return.
The Site Details page lets you view and modify site details. When the site 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 trail.
To view and modify site details:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Click the site name link. The Site Details page is displayed, which shows the selected site details.
Modify the site details.
For more details on how to modify site details, see Section A.46.
Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the List of Sites page is displayed.Enter the reason for modifying the site details in the Reason for Change text box and click Submit.
To cancel the changes made to the site details, click Return.
To view the list of audit trails for a particular field, click the corresponding icon.
The List of Sites page lets you approve and reject sites. A site must be approved before you carry out any clinical trials. Once you approve a site, you cannot approve it again unless the site details are modified. You can approve or reject sites depending on your access rights.
To approve or reject sites:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Select the check box corresponding to the site you want to approve or reject.
Select Approve or Reject from the Select drop-down list. If you select Reject, enter the reason for rejection in the Comments text box.
Click Go.
If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. To cancel approval, click Cancel.
The Status for the selected site changes based on the action performed.
Site information is uploaded to the InForm system if the applicable sites are marked as Uploaded to InForm in UMT.
To mark a site as uploaded to InForm:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site you want to mark as uploaded to InForm.
Select Mark Upload to InForm from the Select drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
Sites which no longer participate in a study can be marked as not participating, making them inactive in the study. The site user accounts associated only with the non-participating site are marked as terminated.
To mark sites as non-participating:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site you want to mark as non participating.
Select Mark as Not Participating from the Select drop-down list and enter your comments in the Comments text box.
Click Go.
Click OK on the confirmation dialog box.
You can view the list of not participating sites under the trial of a sponsor company.
To view not participating sites:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Click the View Not Participating Sites link. The List of Not Participating Sites page appears.
The list of not participating sites for the selected sponsor company and trial is displayed.
Note:
To view not participating sites from a different trial of the same sponsor company, select the trial from the Trial drop-down list.To view not participating sites for a different sponsor company, select the sponsor company and the trial from the Current Sponsor Company and Trial lists.
To view the list of sites again, click Back.
You can mark a not participating site as participating again. Users associated with such sites are no longer considered terminated.
To mark a not participating site as participating:
Open the list of not participating sites.
The List of Not Participating Sites page is displayed.
Select the check box corresponding to the site you want to mark as participating.
Click Mark as Participating.
Click OK on the confirmation dialog box.
You can assign a study version to a site or update the study version after you have modified a site.
To assign or update study version:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site whose study version you want to update by specifying at least one search criteria.Select the check box corresponding to the site you want to mark as assigned or update study version.
Select Assign study version from the Select drop-down list.
Select the version from the study version drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
The Export to Excel and Export to File links available on the List of Sites page let you export site details to an Excel spreadsheet or a flat file.
To export sites:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Select the check box corresponding to the site 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.
The List of Sites page lets you mark sites as uploaded to IRT.
To mark a site as uploaded to IRT:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site you want to mark as uploaded to IRT.
Select Mark Upload to IRT from the Select drop-down list.
Click Go.
Click OK on the confirmation dialog box.
The List of Sites page also lets you update the assessment status for a site.
To update the assessment status for a site:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site whose assessment status you want to update.
Select Update Assessment Status from the Select drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
The List of Sites page lets you send an assessment email for a site.
To send an assessment email for a site:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site for which you want to send an assessment email.
Select Send Assessment Email from the Select drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
The List of Sites page lets you stop the assessment process for a site.
To stop the assessment process for a site:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site for which you want to stop the assessment process.
Select Stop Assessment Process from the Select drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
The List of Sites page lets you assign a preferred study locale for a site.
To assign a preferred study locale for a site:
Select Sites from the menu bar. The List of Sites page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.
Note:
You can also search for the site you want to mark by specifying at least one search criteria.Select the check box corresponding to the site for which you want to assign a preferred study locale.
Select Assign Preferred Study Locale from the Select drop-down list.
Enter the reasons in the Comments text box and click Go.
Click OK on the confirmation dialog box.
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