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This page tree provides instructions for Site Administrators. A Site Administrator is a user with administrative privileges who is responsible
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About Site Administration
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Granting and Revoking Administrative Authority
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| MultiExcerptName | siteadmin |
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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
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System-generated emails (including TSRs) are sent to a site administrator only if the site administrator's affiliated organization is the trial's lead organization, or if the site administrator is the trial submitter and/or trial owner. The site administrator can also manage email notification globally on the My Account page. |
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
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To promote the user to site administrator, select the check box in the Allow as Site Admin? column.
Warning As a site administrator you can revoke your own administrative rights. Use caution if you do so because you can not promote yourself thereafter.
To revoke administrative access, clear the check box under the Allow as Site Admin? column.
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Viewing Accrual Assignment History by Trial
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| MultiExcerptName | accrualaccesshistorybytrial |
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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
- 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 .
Assigning and Unassigning Accrual Access
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| MultiExcerptName | accrualaccess |
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- Assigning Site Administrator status to other users in the organization
- Reviewing and updating user access to trials associated with the organization
- Authorizing users to submit subject accrual data for trials that have been fully abstracted and verified
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The table below outlines the access and trial assignment rules for Complete and Abbreviated trials.
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- A registered user logged in as Site Administrator for any trial other than DCP or CTEP trials
- Super Abstractor for DCP and CTEP trials
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Complete trials for which the assigner's organization is the lead organization
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Abbreviated trials for which the assigner's organization is the Lead Organization or participating site
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- By trial
- By Organization
By Organization Family member
The system automatically assigns the Organization Family Accrual Submitter access to any trial registered by new organizations added to an organization family in the future. It withdraws access if the Organization Family Accrual Submitter's organization is removed from the organization family in the future.
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- By trial
- By participating site
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- All complete trials registered by the submitter's organization or family member organization
- Trials currently registered in CTRP
- Trials that the organization registers in CTRP in the future, once abstracted
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- All abbreviated trials registered by the submitter's participating site only
- Trials currently registered in CTRP
- Trials that the organization registers in CTRP in the future, once abstracted
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Assigning and Unassigning Accrual Access by Trial
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| MultiExcerptName | accrualaccessbytrial |
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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
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- 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.
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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.
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To view the entire text of a trial's title, hover your cursor over the part of the title displayed. |
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Trials in the Not Assigned list that have not been validated appear in grey text and are unavailable for selection. |
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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 ( >> ).
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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.
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Optionally, in the Comment box, enter a comment about this assignment, and then click Save.
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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.
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Assigning and Unassigning Accrual Access by Site
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| MultiExcerptName | accrualaccessbysite |
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As a site administrator, you can assign a user Accrual access globally by site.
How to Assign Accrual Access by Site
- On the toolbar, click Administration > Accrual Access > Manage.
The Manage Accrual Access page appears. - Select Make user a Site Submitter.
Select the user from the Select a user drop-down list.
Click Assign/Unassign.
To unassign access, click Assign/Unassign again.
Assigning and Unassigning Accrual Access by Organization Family
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| MultiExcerptName | accrualaccessbyfamily |
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As a site administrator, you can assign a user Accrual access globally by organization family.
How to Assign Accrual Access
- On the toolbar, click Administration > Accrual Access > Manage.
The Manage Accrual Access page appears. - Select Make user an Org Family Submitter.
Select the user from the Select a user drop-down list.
Click Assign/Unassign.
To unassign access, click Assign/Unassign again.
Viewing Accrual Assignment History
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| MultiExcerptName | accrualaccesshistory |
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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
- On the toolbar, click Administration > Accrual Access > Assignment History.
The Accrual Assignment History page lists all access assignments and assignments.
- To navigate the table, refer to Working with Tables and Search Results .
- 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.
Managing Trial Ownership
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| MultiExcerptName | manageownership |
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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.
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The example above is based on Complete trials. The same principals apply to Industrial trials but site record ownership rather than trial ownership is affected by affiliate changes. |
Assigning Trial Ownership
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| MultiExcerptName | trialownershipassign |
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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.)
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Additionally, you can indicate which of the owners you assign will receive notifications about the trial(s) via email.
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| Users must have a CTRP account, complete with organizational affiliation, in order for you to grant them trial ownership. |
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
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You may not be able to change trial ownership using the Manage Trial Ownership functionality in certain circumstances. For example, you may not be able to change trial ownership if the trial status is Complete rather than Active, and the lead organization is not the trial submitter's affiliated organization. (Refer to Recording Site Recruitment Statuses and Dates .) However, you can request trial ownership changes by contacting the CTRO. When requesting trial ownership changes, include the new owner's first name, last name, and email address. Ensure that the user has registered in CTRP or has a valid CTRO account. |
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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The organization must be a lead organization for Complete trials, or a participating site for Abbreviated trials. |
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| Footnotes Display |
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| MultiExcerptName | trialownershipmanage |
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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.
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- For Complete trials, select Lead Organization.
- For Abbreviated trials, select Participating Site.
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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.
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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. |
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To unassign trials, under Trial Ownership Assignments, or Site Owner Assignments, select the user(s) you want to unassign, and click the Unassign icon (<).
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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.
Note 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.
Displaying Trial Ownership
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| MultiExcerptName | trialownershipdisplay |
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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.
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Trial owners can access TSR and XML documents. |
How to Display Trial Ownership
- 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.
- 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. 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.Tip title 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.
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.
Info 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.
- To revoke ownership of a trial, locate the user/trial in the Search Results list, and then click Remove.
Adding Sites
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| MultiExcerptName | addingsites |
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Managing Program Codes
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| MultiExcerptName | managingprogramcodes |
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- Adding participating sites to Abbreviated trials
Managing the set of program codes and program code assignments for the organization family
- Managing targeted accrual, the total number of participants expected to accrue at all of the sites within your organization family participating on a study.
This page tree introduces you to site administration management and provides instructions for these tasks.
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Each cancer center family uses program codes to group its clinical trials. As a site administrator, you can manage the set of program codes and program code assignments for your organization family. You can assign program codes to trials that meet all of the following criteria:
- Complete trials with a lead organization as a member of your cancer center family of organizations, or Abbreviated trials where such a member is a participant.
- Trials with status other than Withdrawn.
- Trials with processing status other than Rejected or Submission Terminated.
- Trials that were active during the cancer center reporting period.
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Viewing Program Codes
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| MultiExcerptName | viewingprogramcodes |
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You can navigate through the list of program codes just like any other list of search results in the CTRP Registration application. For instructions, refer to Working with Tables and Search Results.
Adding Program Codes
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For each organization family, active program codes must be unique. The list may contain two entries with the same program code, if one is active and the other is inactive. |
Editing Program Codes
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When you change a program code, the system re-assigns to the new program code all trials (including closed trials) currently assigned to the old program code.
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Deleting or Inactivating Program Codes
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Viewing the Assignments for a Program Code
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| MultiExcerptName | viewingprogramcodeassignments |
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- The default end date is 12/31/2015. In the Reporting Period End Date field, consider specifying a different date.
- The default reporting period length is 12 months. In the Reporting Period Length field, consider specifying a different number.
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In Review
Approved
Active
Enrolling by Invitation
Temporarily Closed to Accrual
Temporarily Closed to Accrual and Interventions
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You can navigate through the list of trials just like any other list of search results in the CTRP Registration application. For instructions, refer to Working with Tables and Search Results. On the Program Code Assignments page, in the search box, if you include the search term in double quote marks (for example "cancer"), the search results include trials that have an exact match in any of the first five columns.
Assigning a Program Code to a Single Trial
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You can also assign a program code to a trial while performing the following tasks:
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Unassigning a Program Code from a Single Trial
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On the Manage Program Code Assignments page, in the row for the trial of interest, in the Program Code(s) column, click the x for the program code you want to unassign. The Program Code(s) column reflects your changes. You can also unassign a program code to a trial while performing the following tasks:
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Assigning Program Codes to Multiple Trials
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Unassigning Program Codes from Multiple Trials
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Replacing a Program Code
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Viewing Your Participation
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