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This page provides instructions for Site Administrators. A Site Administrator is a user with administrative privileges who is responsible for:
- Assigning Site Administrator status to other users in the organization
- Reviewing and updating user access to trials owned by the organization
- Authorizing users to submit subject accrual data for trials that have been fully abstracted and verified
- 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 introduces you to site administration management and provides instructions for these tasks.
About Site Administration
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Granting and Revoking Administrative Rights
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| MultiExcerptName | siteadmin |
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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 Site Administrators and trials in a single site are as follows:
- An organization:
- Can have one original Site Administrator.
- Can have many Site Administrators appointed by the original Site Administrator.
- Can be the lead organization for many trials.
- Can be the affiliated organization for many users who can submit and own trials.
- A trial:
- Can have one submitter.
- Can have one organization affiliation, defined by the lead organization.
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 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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The system sends generated emails (including TSRs) 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 Administrator, you can grant and revoke administrative rights to other users in your organization. (You can grant/revoke administrative rights 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 access the Site Administration menu.
How to Grant and Revoke Site Administrative 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 in the Allow as Site Admin? column.
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Assigning and Unassigning Accrual Access
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| MultiExcerptName | accrualaccess |
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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.
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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 anyone removes the organization family Accrual Submitter's organization 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
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. You can assign specific trials to specific users.
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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 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 ( >> ).
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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 additional trials. Then click the single arrow ( > ) under Assign. |
A Comments box appears.
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Optionally, in the Comments 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 the accrual assignment. 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. 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.
- 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.
To assign access, click Assign.
To unassign access, click Unassign.
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. You 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.
- 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.
To assign access, click Assign.
To unassign access, click Unassign.
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.
- On the toolbar, click Administration > Accrual Access > Assignment History. The Accrual Assignment History page lists all access 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.
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.
- 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.
- 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.
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(TBD: Recapture screenshots & revise text to reflect an obviously fake name, such as Jane Doe.) |
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, 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.
- 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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The example above involves Complete trials. The same principles apply to Abbreviated trials, but changes in affiliation affect site record ownership rather than trial ownership. |
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 tell the system to send notifications about the trial(s) via email to the owners you assign.
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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. |
The system stores your affiliated organization 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 its family member organizations. For example, if you are affiliated with the M D Anderson Cancer Center, you can manage trial assignments 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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The organization must be a lead organization for Complete trials, or a participating site for Abbreviated trials. |
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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 following lists:
At the top of the page: The names of users affiliated with your affiliated organization or its family member organization(s).
Below the list of names: Trials that your organization owns as a lead organization or participating site.
- Under Manage trial record ownership for, select which role your affiliated organization or its family member organization(s) play(s).
- For Complete trials, select Lead Organization.
- For Abbreviated trials, select Participating Site.
Indicate which users you want to give the ability to update and amend selected Complete trials; or update Abbreviated trials. To do so, select one or more user names on the list.
Tip title 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 system filters the list as you type each character.
In the list of trials at the bottom of the page, under All Available Trials, or All Available Abbreviated Trials, select the trials to assign to the user(s), and then click the Assign icon ( > ).
To unassign trials, under Trial Ownership Assignments, or Site Owner Assignments, select the user(s) you want to unassign, and click the Unassign icon ( < ).
For Complete trials, indicate which trial owners should receive email notifications about the trial(s):
To indicate that a specific user should or should not receive email, in the Email Notification? column, in the row for that user, click Yes or No.
To indicate that all owners should or should 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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You can perform the following tasks on the trials you own:
- View trial details
- Update trials
- Amend Complete trials
- Access TSR and XML documents
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. 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
- 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, receive system-generated email notifications.
- You have the following search options:
- 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. The system lists all trials owned by the user 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. The system lists all owners of the selected trial in the Search Results list.
- You have the following options to manage trial ownership:
Indicate whether or not an owner of a trial should receive system-generated email messages. To do so, in the Receive Email? column, select Yes or No.
Selecting Yes indicates that you want the owner to receive all notifications regarding the specified trial.
Selecting No indicates that you do not want the owner to 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.
- You have the following additional options:
To filter the search results, in the Search field, type one or more characters contained in any of the fields. The system filters the list as you type each character. 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.
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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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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- If the list has been filtered, in the Program Code(s) column header, click the button that indicates the number of program codes selected. The list includes all program codes for the organization family and other options.
- If the list has not been filtered yet, in the Program Code(s) column header, click the filter icon (
). The Select Program Code(s) button appears. Click Select Program Code(s). The list includes all program codes for the organization family and other options.
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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 Manage 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 Assignment & Targeted Accrual for Your Center 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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Managing Targeted Accrual
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