The Site Administrator for a site is the CTRP user with the following qualities:

• The CTRO or another Site Administrator has granted the user profile the administrative rights.
• The user profile is affiliated with that site (an organization family or a single organization that does not belong to an organization family).

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

• An organization can have the following:
  • One original site administrator
  • Can have one original Site Administrator.
  • Can have many Site Administrators Many site administrators appointed by the original administrator
  • Many trials, providing that the organization plays the lead organization role
  • Site Administrator.
  • Can be the lead organization for many trials.
  • Can be the affiliated organization for many users Many users affiliated with the site who can submit and own trials.
• A trial can have the following:
  • One Can have one submitter.
  • One Can have one organization affiliation, defined by the lead organization.

  • Many Can have many trial owners.

• Trial ownership:
  • Can be implicit. By default, if a Site Administrator's affiliated organization is the

• • lead organization for a trial, that Site Administrator is an implicit owner of that trial.
  • Can be explicit. By default, the trial submitter is the only explicit trial owner. A Site Administrator can grant ownership of a trial to more users and can remove trial ownership from the original submitter and other users. (Refer to Managing Trial Ownership.) If you add a Site Administrator as an owner of a trial, that Site Administrator has explicit ownership of that trial, rather than just implicit ownership.
• A Site Administrator A site administrator can do the following:
  
  • Display trial ownership
  • Manage trial ownership
  • Manage site record ownership 
  • Manage Accrual accrual access
  • Manage the administrative rights of other users in the organization

  • Revoke own administrative rights

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

How to Grant and Revoke Site Administrator Administrative Rights

1. On the toolbar, click Administration > Site Administration.

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   The Site Administration page appears, listing the administrators to whom administrator rights Registration users and indicating which ones have previously been granted , if applicableadministrative rights.
   
2. Search for the Registration user for whom you want to adjust administrative rights: specify 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 administratorSite Administrator, select the check box in the Allow as Site Admin? column.

      Warning
      As a site administrator 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 in the Allow as Site Admin? column.

3. Click Save.

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 or Other), 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.

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 Site Administrator, you can assign a user Accrual accrual access to any trial that the user submitted to the CTRP or currently owns. How to Assign Accrual AccessYou can assign specific trials to specific users.

1. On the toolbar, click Administration > Accrual Access > Manage.

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   The Manage Accrual Access page appears.
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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.
3. 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.
4. 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.
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5. 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.

   Tip
   To view the entire text of a

   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.

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

   

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

6. In the Select a trial category list, consider narrowing the list of trials to a category.

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

   Tip
   title 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 othersadditional trials. Then click the single arrow ( > ) under Assign.

   A comment Comments box appears.

   

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

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

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

9. 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 ( << ).
10. Optionally, enter a comment in the Comments comment box, and then click Save.
    The system moves the trial(s) you selected are moved to the Not Assigned list, and the user will no longer have has access to them.

As a site administratorSite Administrator, you can assign a user Accrual accrual access globally by site. You can grant users rights to submit accruals for all trials in CTRP that have been submitted or will be submitted by the affiliated 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/UnassignTo assign access, click Assign.

5. To unassign access, click Assign/click Unassignagain.

As a site administratorSite Administrator, you can assign a user Accrual accrual access globally by organization family. How to Assign Accrual AccessYou can 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.

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/UnassignTo assign access, click Assign.

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

Trials are associated The system associates trials 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, last submitter and trial owner. And M D Anderson is the last Submitter Organization submitter organization and trial owner.

The CTRP system identifies the trial by the Last Submitter last submitter and the last Submitter Organizationsubmitter 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, the results depend on the extent of the change:

• If she 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.
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• If she 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.
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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 tell the system to send notifications about the trial(s) via email to the owners you assign.

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 The system stores 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 its 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.for trials owned by the M D Anderson International and UF Cancer Center at Orlando Health organizations. The following image lists the organizations in the M.D. Anderson Cancer Center organization family. 

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