The relationships between administrators and trials in a single organization are as follows:

• An organization can have the following:
  • One original site administrator
  • Many site administrators appointed by the original administrator
  • Many trials, providing that the organization plays the lead organization role
  • Many users affiliated with the site who can submit and own trials
• A trial can have the following:
  • One submitter
  • One organization affiliation, defined by the lead organization

  • Many trial owners

Site administrators are trial owners by default if the site administrator's affiliated organization is the trial's lead organization. A site administrator can be added explicitly as an owner of any trial. Refer to  Managing Trial Ownership .

• A site administrator can do the following:
  
  • Display trial ownership
  • Manage trial ownership
  • Manage site record ownership 
  • Manage Accrual access
  • Manage the administrative rights of other users in the organization

  • Revoke own administrative rights

As a site site administrator, you can grant and revoke administrative rights to other users in your organization. (You can grant/revoke administrative authority to users who have a CTRP account and whose organizational affiliation is the same as your own.) Site administrators are the only Registration users who can see and access the Site Administration menu.

How to Grant and Revoke Site Administrator Rights

1. On the toolbar, click Administration > Site Administration.
   The Site Administration page appears, listing the administrators to whom administrator rights have previously been granted, if applicable.
   
2. Search for the Registration user for whom you want to adjust administrative rights: specify the user by first name, last name, or email address, and then click Search. The user's name appears in the Search Results list.

   1. To promote the user to site administrator, select the check box in the Allow as Site Admin? column.

      As a site administrator you can revoke your own administrative rights. Use caution if you do so because you can not promote yourself thereafter.

   2. To revoke administrative access, clear the check box under the Allow as Site Admin? column.

3. Click Save.

As a site administrator, you can view a history of your organization's accrual access assignment on a per-trial basis.

How to View Accrual Assignment History by Trial

1. On the toolbar, click Administration > Accrual Access > View.
   The Accrual Access Assignment by Trial page lists all current access assignments by trial, grouped by trial category.
   
   To navigate the table, refer to  Working with Tables and Search Results .

Site Administrators can authorize users to submit subject accrual data for trials that have been fully abstracted and verified. Once assigned, users can submit accrual data for all trials associated with their affiliated organization or organization family members. For Complete trials (National, Externally Peer-Reviewed, or Institutional), the organization must be a lead; for Abbreviated trials (Industrial), the organization must be a participating site.

Assignment at the organization level pertains to trials that the organization has registered in CTRP and extends to those that it will register in the future. Similarly, assignment at the organization family level pertains to trials that any member organization has registered in CTRP and extends to those that it will register in the future.

The table below outlines the access and trial assignment rules for Complete and Abbreviated trials.

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As a site administrator, you can assign a user Accrual access to any trial that the user submitted to the CTRP or currently owns.

How to Assign Accrual Access

1. On the toolbar, click Administration > Accrual Access > Manage.
   The Manage Accrual Access page appears.
   
2. Select an assignment type.
   
   • Select Assign user access to individual trials to assign specific trials to specific users. If you select this option, the Select a trial category list appears where you can narrow the list of trials to a category.
   • Select Make user a Site Submitter to grant users rights to submit accruals for all trials in CTRP that have been submitted or will be submitted by the affiliated site.
   • Select Make user an Org Family Submitter to grant users rights to submit accruals for all trials in CTRP that have been submitted or will be submitted by any site that is a member of the organization family.

3. From the Select a user list, select the user to whom you want to assign or unassign accrual submission privileges.
   The list of trials available for accrual submission for the user you selected appears in the Not Assigned list on the left side of the page, and trials to which access had previously been granted (if any) appear on the right.

   To view the entire text of a trial's title, hover your cursor over the part of the title displayed.

   

   Trials in the Not Assigned list that have not been validated appear in grey text and are unavailable for selection.

4. From the Not Assigned trial list, select the trial to which the user will submit accrual data, and then click the single arrow ( > ) under Assign. Or, to assign all eligible trials, click the double arrow ( >> ).

   You can select multiple trials

   To select multiple trials, click one trial, then press and hold the CTRL (or CMD) key and click one or more others. Then click the single arrow ( > ) under Assign.

   A comment box appears.

   

5. Optionally, in the Comment box, enter a comment about this assignment, and then click Save.

   Comments are optional. You can leave the comment field blank and still save it. To abort the assignment, click Cancel instead.

   A message confirms your assignment. The assigned trial(s) appear in the Assigned list.

6. To unassign access, from the Assigned trial list, select the trial you want to unassign, and then click the single arrow ( < ) under Unassign. Or, to unassign all trials, click the double arrow ( << ).
7. Optionally, enter a comment in the Comments box, and then click Save.
   The trial(s) you selected are moved to the Not Assigned list, and the user will no longer have access to them.

As a site administrator, you can assign a user Accrual access globally by site.

How to Assign Accrual Access by Site

1. On the toolbar, click Administration > Accrual Access > Manage.
   The Manage Accrual Access page appears.
2. Select Make user a Site Submitter.
   

3. Select the user from the Select a user drop-down list.

4. Click Assign/Unassign.

5. To unassign access, click Assign/Unassign again.

As a site administrator, you can assign a user Accrual access globally by organization family.

How to Assign Accrual Access

1. On the toolbar, click Administration > Accrual Access > Manage.
   The Manage Accrual Access page appears.
2. Select Make user an Org Family Submitter.
   

3. Select the user from the Select a user drop-down list.

4. Click Assign/Unassign.

5. To unassign access, click Assign/Unassign again.

As a site administrator, you can view a history of your organization's trials to which users have been assigned/unassigned user access.

How to View Accrual Assignment History

1. On the toolbar, click Administration > Accrual Access > Assignment History.
   The Accrual Assignment History page lists all access assignments and assignments.
   
2. To navigate the table, refer to  Working with Tables and Search Results .
3. To export the assignment history to a file, click CSV (comma-separated values) or Excel in the bottom left corner.
   Your browser prompts you to open or save the file.

Trials are associated with the user who last submitted the trial, and with the last submitter's affiliated organization.

For example, in the figure below, Isabelle Autissier (username = CTRPDOC1) submitted the trial while affiliated with M D Anderson. She is the Last Submitter, and trial owner. And M D Anderson is the last Submitter Organization and trial owner.

The CTRP system identifies the trial by the Last Submitter and the last Submitter Organization. In the figure below, username CTRPDOC1 is affiliated with M D Anderson as per the account information in the figure above.

If Isabelle Autissier changes her organization affiliation to another within the organization family such as U.T. M.D Anderson Cancer Center after having submitted the trial, both she and her original organization retain trial ownership.

However, if Isabelle Autissier changes her organization affiliation to an organization outside the organization family such as Vanderbilt-Ingram Cancer Center, she loses trial ownership of all trials affiliated with M D Anderson. Her trial will not be among the "Search My Trials" results. M D Anderson Cancer Center retains trial ownership; Vanderbilt-Ingram Cancer Center does not assume trial ownership despite the Last Submitter's new organization affiliation.

As a Site Administrator, you can assign and unassign trial ownership rights to multiple users in your affiliated organization and its family member organizations, and multiple trials at the same time. (Trials displayed on the Manage Trial Ownership page are those that you have submitted or those submitted by users if the trial's lead organization is the same as your affiliated organization or its family member organizations.)

For example, you can grant ownership of one trial to three CTRP users within your organization. Or, you can grant one user ownership of three trials.

Additionally, you can indicate which of the owners you assign will receive notifications about the trial(s) via email.

For Abbreviated trials, owners are responsible for updating their affiliated organization's information on trials in which their site is a participant, using the Update My Site action. Owners can update the following information:

• Organization family's program code
• Organization's local trial identifier
• Site principal investigator
• Site recruitment status and dates

Your affiliated organization is stored with your account information on the My Account page. Your affiliation determines which trials and which users you can assign.

You can assign any trial submitted by your affiliated organization or it family member organizations. For example, if you are affiliated with the M D Anderson Cancer Center, you can manage trial assignments for trials that M D Anderson International and UF Cancer Center at Orlando Health own.

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How to Assign and Unassign Trial Ownership

1. On the toolbar, click Administration > Trial Ownership > Manage.
   The Manage Trial Ownership page displays the names of your affiliated organization or it's family member organization(s) users on the top of the page, and trials that your organization owns as a Lead Organization or Participating Site below the list of names.
   

2. Under Manage trial ownership for, select which role your affiliated organization or its family member organization(s) play(s).
   
   1. For Complete trials, select Lead Organization.
   2. For Abbreviated trials, select Participating Site.

3. To indicate which users will have the ability to update and amend selected Complete trials; or update Abbreviated trials, select one or more user names on the list.

   You can select or deselect all names, or filter the list of names

   To select all names, select the check box  on the left side of the column heading. Click it again to deselect all names.

   To filter the list of names, in the Search field, type one or more characters contained in a user's name or email address. The list is filtered as you type subsequent characters.

4. In the list of trials at the bottom of the page, under All Available Trials, or All Abbreviated Trials, select the trials to assign to the user(s), and then click the Assign icon ( > ).

   

5. To unassign trials, under Trial Ownership Assignments, or Site Owner Assignments, select the user(s) you want to unassign, and click the Unassign icon (<).

6. For Complete trials, indicate which trial owners should receive email notifications about the trial(s):

   • In the Email Notifications? column, click the Yes or No button.

     

   • To indicate that all owners should receive/not receive email, in the Email Notification column header, click All > Select Yes/No for all.
     

     The Select No for All and Select Yes for All options apply globally to all trial owners, not just the ones currently visible in the list.

As a site administrator, you can display trial ownership for any trial owned by your site for which your organization or its family member organization is the lead organization. Trial owners can view trial details, update trials, and amend Complete trials. Additionally, you can indicate whether a user would like to receive system notifications, including TSRs and XML files, on a trial-by-trial basis.

How to Display Trial Ownership

1. On the toolbar, click Administration > Trial Ownership > View.
   The Display Trial Ownership page displays the current owner(s) of the trials for which your organization is the lead organization. It also indicates which of the owners, for each of the trials, will receive system-generated email notifications.
   
2. To display all the trials owned by a given user, search for the user by first name, last name, or email address, and then click Search.
   All trials owned by the user are listed in the Search Results list.

3. To display all owners of a given trial, enter the NCI Identifier in the field provided, and then click Search.
   All owners of the selected trial are listed in the Search Results list.

   You can filter the search results and create more space to display the results

   To filter the search results, in the Search field, type one or more characters contained in any of the fields. The list is filtered as you type subsequent characters. For details, refer to Working with Tables and Search Results .

   To create more space on the page, on the upper right corner of the page, select the Hide Search Criteria check box.

4. To indicate whether or not an owner of a trial should receive system-generated email messages, in the Receive Email? column, select Yes or No.

   Selecting Yes indicates that the owner will receive all notifications regarding the specified trial.

   Selecting No indicates that the owner will not receive any notifications regarding the specified trial.

5. To revoke ownership of a trial, locate the user/trial in the Search Results list, and then click Remove.