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MultiExcerptNamesiteadmin

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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

 

Note
titleSite administrators do not receive system-generated emails automatically

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

  1. On the toolbar, click Administration > Site Administration.
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    The Site Administration page appears, listing Registration users and indicating which ones have previously been granted administrative rights.
    Site Administration page
  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.

      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.

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

  3. Click Save.

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accrualaccesshistory

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

  1. On the toolbar, click Administration > Accrual Access > Assignment History. The Accrual Assignment History page lists all access assignments.
    Accrual Access Assignment History page
  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.

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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.

  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.
    Accrual Access Assignment by Trial page showing trials grouped by trial category
  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.

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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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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.

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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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titleTrial ownership requirements

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.

My Account page showing organization affiliation to M D Anderson Cancer Center

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.

List of organizations

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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

  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, receive system-generated email notifications.
    Display Trial Ownership page listing current owners
  2. 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.

  3. 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.
  4. 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.

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  1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the View icon (View icon, as it appears in the Manage Program Codes Master List page (arrows pointing left and right)). The Manage Program Code Assignment & Targeted Accrual for Your Center page appears.
    The Manage Program Code Assignment and Targeted Accrual for Your Center page
  2. Notice that this page displays information specific to a date range:
    • 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.
  3. Notice that this page displays a list of trials that meet all the following criteria:
    • Trials in which any member of your organization family is a participant.
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      Program Code Administrator - Include v4.4
    • Trials assigned the program code that you selected on the Manage Program Codes Master List page.
    • Trials with any of the following statuses at any time within the reporting period, as specified on this page:
      • In Review

      • Approved

      • Active

      • Enrolling by Invitation

      • Temporarily Closed to Accrual

      • Temporarily Closed to Accrual and Interventions

  4. If you want to adjust the list filter, instructions depend on whether the list is already filtered:
    1. 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.
    2. If the list has not been filtered yet, in the Program Code(s) column header, click the filter icon (Filter icon, as it appears in the Manage Program Codes Master List page (funnel shape)). 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.
  5. Select one or more program codes from the list. (To select all program codes or deselect all program codes, toggle the Select/Deselect All option. To display trials that have not been assigned to program codes, select None.) The system updates the list of trials to reflect your selections.

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.

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  1. 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 v icon.
    Program Code(s) column with v icon
    The Program Code field appears.
    Program Code(s) column code selection field
  2. Click the Program Code field. The list includes all program codes for the organization family, but the ones already assigned to the selected trial are unavailable for selection.
  3. Select the target program code. The Program Code(s) column reflects your changes.

You can also assign a program code to a trial while performing the following tasks:

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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.

Program Code(s) column with x icon

You can also unassign a program code to a trial while performing the following tasks:

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