Registry Help Topics v4.4

• You can create a new NIH grant record only if you can provide all of the following details:
  
  • Funding Mechanism
  • NIH Institution Code
  • Serial Number
  • NCI Division/Program
• You can not change the following existing information:
  
  • NCI trial identifier number
  • NIH grant number
  • IND/IDE serial number
• The following list is the minimum set of required documents that must be submitted with each amendment:
  
  • Protocol document.
  • IRB approval document.

  • A change memo document or protocol highlighted document:

    • A change memo is a document that contains a summary of changes as compared to the original, or last amended, trial submission.

    • A protocol highlighted document is a document that has been marked up, with or without using a Track Changes feature.

  • List of participating sites and contact information (for multi-site trials, if not included in the protocol document).

  • Informed consent (if not included in the protocol document) and only when there are documented changes to the consent.

When you are submitting an amendment, we recommended that you provide any additional documents that you think will be useful to the CTRO for reviewing and processing the amendment document.

• Dose Escalation Amendment (change in the number of patients treated at a given dose level)
• Change in Sites Open to Patient Accrual
• Change in Principal Investigators
• Change in Risk to Participants (new risk identified [new CAEPR], changes made as a result of an updated Severe Adverse Event)
• Scientific Change (opening an arm, adding a new arm, closing an arm, changing objectives, changing statistical analysis, adding correlative studies, increase or decrease in the accrual goal, changing from Phase I to Phase II, additional data points)
• Correction of Typographical Errors which Change Scientific Meaning (mg vs. mcg)
• Eligibility Change (change to the inclusion or exclusion criteria)
• Therapy Change (change in dose, adding another agent, change in administration, change in route)

To open the trial record for amending, refer to Amending Trials.

Trial-related documents uploaded as Microsoft Word (.doc), Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb), and WordPerfect files contain text that abstractors can copy and paste directly. PDFs (portable document format) contain text that abstractors can copy  only if the content was created from other text-based applications such as Word or Excel.

Abstractors can not copy and paste text from scanned documents

Avoid uploading PDFs of scanned documents. They can not be edited, copied, or read with OCR (optical character recognition) applications.

Adobe provides a plug-in for most text-based word processing applications that enables you to convert your files to PDFs. Once you have converted the files, you can read the documents in Adobe Reader. Others can read the content as well but are not able to make changes to your file. You can download the Adobe PDF Reader for free from the Adobe website .

Microsoft provides instructions for converting files to PDFs both on their website and in the Help documentation in each of its applications.

How to Convert Text-Based Files to PDFs in Mac OSX

1. Open your text file in its original format (such as .doc or .xls).
2. Click File > Print.
3. In the Print window, click the PDF button at the bottom-left and select the Save as PDF option.
4. Choose the file location, rename your PDF file, and then click Save.

• 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 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.
   
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.

• 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

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. The Site Administration page appears, listing Registration users and indicating which ones have previously been granted administrative rights.
   
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 in the Allow as Site Admin? column.

3. Click Save.

1. 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 on which your organization is a lead organization or participating site.

     
     

     
     

2. Under Manage trial record 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. 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.

   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.

4. 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 ( > ).

   

   
   

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):

   • 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.
     

     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.

For instructions, refer to the following pages:

1. On the toolbar, click Administration > Manage DT4 Information > Manage Program Code Master List. The Manage Program Codes Master List appears.
   

2. Notice that this page displays information specific to your organization family.

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.

1. On the Manage Program Codes Master List page, in the Program Code field, enter a unique program code. This is likely to be a very short representation of the program.
   
2. (Optional) In the Program Name field, enter a program name.
3. Click Add Program Code. The new program code appears in the list.

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.

1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the Edit icon (). The Edit Program Code dialog box appears.
   
2. Change the program code, program name, or both.
3. Click Save.
   
   • If you have changed only the program name, the list reflects your change.
   • If you have changed the program code, a confirmation message appears. If you want to proceed, click Yes. The list reflects your change.

1. On the Manage Program Codes Master List page, in the row for the program code of interest, click the View icon (). The Manage DT4 Information for Your Center page appears.

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.

   • 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 (). 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.

1. On the Manage DT4 Information for Your Center page, in the row for the trial of interest, in the Program Code(s) column, click the v icon.
   
   The Program Code field appears.
   
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:

• Registering, amending, or updating a Complete trial. For instructions, refer to Registering New Trials, specifically Recording Data Table 4 Information.
• Adding your site after importing a trial. For instructions, refer to Registering Abbreviated (Industrial and Other) Trials.
• Adding a participating site to an Abbreviated trial or updating such a site (as a site affiliate). For instructions, refer to Adding Your Site to Abbreviated Trials.
• Adding participating sites to Abbreviated trials (as a Site Administrator). For instructions, refer to Adding Sites.

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

• Amending or updating a Complete trial. For instructions, refer to Registering New Trials, specifically Recording Data Table 4 Information.
• Adding a participating site to an Abbreviated trial or updating such a site (as a site affiliate). For instructions, refer to Adding Your Site to Abbreviated Trials.
• Adding participating sites to Abbreviated trials (as a Site Administrator). For instructions, refer to Adding Sites.

1. On the toolbar, click Administration > Manage DT4 Information > Manage DT4 Information for Your Center. A page by that name appears.

2. In the row for the trial of interest, in the Targeted Accrual for Your Center column, specify the targeted accrual:
   
   1. Click the existing value (or Empty). A text box appears.
      
   2. Change the value or enter a new one. When done, click the check mark. The system saves your changes.

This value appears in the Your Center Total column of the Data Table 4 report. For instructions on generating that report, refer to Running CTRP Data Table 4 Reports.

1. 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 on which your organization is a lead organization or participating site.

     
     

     
     

2. Under Manage trial record 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. 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.

   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.

4. 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 ( > ).

   

   
   

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):

   • 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.
     

     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.

How to Edit Your Account Information

1. Visit the CTRP Registration home page at https://trials.nci.nih.gov/registration.
2. Log in.
3. On the top right corner of any page, click  Your Username > My Account.
   The My Account page appears, populated with the information you previously supplied for your account.

4. In the Your Account Profile section, make any changes as necessary, and then click Save.

   Keep your account up to date

   The PRS organization name is required for uploading trial records to ClinicalTrials.gov via a system-generated file. The PRS organization name you include in your profile is included in that file. This precludes having to update the PRS name in the file. Therefore it is very important for you to update your account whenever there is a change in PRS.

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.
   
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.

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