This section provides instructions for creating CTRP accounts and requesting authorization to abstract trials.
About CTRP Protocol Abstraction
The NCI CTRP Protocol Abstraction web application enables authorized users to query, access, validate, and abstract trials submitted for registration in the Clinical Trials Reporting Program (CTRP). By abstracting trial data in the application, users ensure data integrity within trials and standardization of data across clinical trials.
What's New in this Release of Protocol Abstraction
This version of the CTRP Protocol Abstraction application has the following new features and improvements:
| Issue Type | Development # | Documentation # | Description | Link to Content in this User Guide | Comments |
|---|---|---|---|---|---|
| Bug | PO-8884 | PO-9452 | Validate the logic used to close participating sites when a trial is closed | Closure of Participating Sites When Trial Closes - Include v4.4 | CTRP was using different rules for closing participating sites when a trial was closed for Complete and Abbreviated trials. Now CTRP uses a single set of rules. |
| Improvement | PO-9059 | PO-9449 | Move the trial count panels from the [Workload] tab to a new [Counts] Tab in the SuperAbstractor Dashboard | Tracking and Managing Trial Records v4.4 | This is an Abstraction Dashboard issue. |
| New Feature | PO-9192 | PO-9450 | Allow users in Registry to easily manage Program Codes list for their centers | NA | |
| Bug | PO-9244 | NA | Firefox only: Results Reporting & Tracking Dashboard has unnecessary extra wide spaces in search criteria. | NA | This is a Results Reporting Dashboard issue. |
| Improvement | PO-9282 | PO-9455 | Changes to the "CCCT Review Complete?" section for TCD | Tracking and Managing Trial Results v4.4 | This is a Results Reporting Dashboard issue. |
| Bug | PO-9290 | NA | DW: Duplicate entries in dw_study_other_identifier | NA | NA |
| Bug | PO-9295 | NA | Email and Phone number data validation missing on the "Results Reporting & Tracking - Trial View" page | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9312 | NA | Some NCI-CCR trials are being shown in Results Dashboard search results even though not expected | NA | This is a Results Reporting Dashboard issue. |
| Improvement | PO-9313 | PO-9455 | Results Designee Access Revoked Question in Final Record Cleanup and release section should be redesigned | Tracking and Managing Trial Results v4.4 | This is a Results Reporting Dashboard issue. |
| Bug | PO-9325 | PO-9455 | CTEP/DCP ID column in Results Reporting Dashboard should list the CTEP or DCP trial ID | Tracking and Managing Trial Results v4.4 | This is a Results Reporting Dashboard issue. |
| Bug | PO-9336 | NA | Results Designees added are not reflected in the Dashboard Search Results page | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9338 | NA | Investigate why some NCI Sponsored studies have the Send To CTGov flag NULL in the db | NA | The value of CTRO_OVERRIDE field in the Study_protocol table was NULL and was not handled properly in the code. |
| Bug | PO-9343 | NA | Results TCD review: Typed name does not appear with date | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9361 | NA | Unable to delete TCD document records | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9362 | NA | Unable to update results designee contact phone | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9364 | NA | No validation done to check if 11 digit phone number is valid on "Results Reporting & Tracking - Trial View" page | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9373 | NA | Fax Number is appearing instead of Main Phone Number on Contacts page | NA | NA |
| Bug | PO-9388 | NA | Ensure that all Results Designee names are listed in the table on the Reports Results Dashboard | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9389 | NA | Ensure that the name of the CCCT Reviewer is saved correctly to the database on the Trial Comparison Document results reporting page | NA | This is a Results Reporting Dashboard issue. |
| Bug | PO-9393 | NA | Ensure the user is able to add a date value to “All Changes Made in CTRP and ClinicalTrials.gov” field | NA | This is a Results Reporting Dashboard issue. |
| Improvement | PO-9394 | PO-9449 | Add a Yes/No field to filter by on the Dashboard-Workload tab | Tracking and Managing Trial Records v4.4 | This is an Abstraction Dashboard issue. |
| Improvement | PO-9397 | PO-9449 | Update the calculation of the "Business Days Since Submitted" value on the Dashboard-Workload tab | Tracking and Managing Trial Records v4.4 | This is an Abstraction Dashboard issue. |
| Improvement | PO-9398 | NA | Correct the calculation of the Days on Hold (Submitter and CTRP) field | NA | This is an Abstraction Dashboard issue. |
| Improvement | PO-9399 | PO-9449 | Correct the calculation of the Expected Abstraction Abstraction Completion Date value on the Dashboard-Workload tab | Tracking and Managing Trial Records v4.4 | This is an Abstraction Dashboard issue. |
| Improvement | PO-9400 | PO-9449 | Update the calculation of the "Submission Plus 10 Business Days" date on the Dashboard-Workload tab | Tracking and Managing Trial Records v4.4 | This is an Abstraction Dashboard issue. |
| Improvement | PO-9418 | NA | Make the initial sort order by Expected Abstraction Completion Date ASCENDING. It is currently in descending order | NA | This is an Abstraction Dashboard issue. |
| Bug | PO-9421 | PO-9456 | Update the abstraction validation rule for unique Brief Title to exclude rejected trials from the comparison | Validating Abstractions v4.3 | NA |
| Bug | PO-9433 | NA | Major: Amendment Registration "Cancel" order for NCI-2013-01655 resulted in trial update submission of documents (EW#46745) | NA | CTRP was not handling an empty document properly. |
| Bug | PO-9438 | NA | Major: Request to update "Last Submitter Organization" for NCI-2013-00701 (EW#48231) | NA | NA |
| Improvement | PO-9445 | PO-9455 | Add download to XLS or CSV file to Results Reporting Dashboard | Tracking and Managing Trial Results v4.4 | This is a Results Reporting Dashboard issue. |
| Bug | PO-9446 | NA | Database upgrade (Liquibase) must be moved out of the Ant build process and must be embedded into PA instead | NA | NA |
| Improvement | PO-9457 | NA | A progress indicator for Trial Counts by Date might be useful to indicate the panel is loading | NA | This is an Abstraction Dashboard issue. |
| Bug | PO-9458 | NA | Dashboard: TypeError: 'undefined' is not a function (evaluating '$("#dashboardForm").attr('action').contains('searchByDistribution')') | NA | This is an Abstraction Dashboard issue. |
| Bug | PO-9459 | NA | Major: Incorrect "Last Submitter Organization" Listed and then changed (EW#48521) | NA | NA |
| Bug | PO-9501 | NA | DCP trial (NCI-2014-01311) does not have 'Send to ctgov' flag set | NA | NA |
| Bug | PO-9504 | NA | Blocker: Receiving validation error regarding NCI grant record that is non-existent (EW#49197) | NA | The Trial Funding page in PA would not display the "Is this trial funded by an NCI grant" option if there were no grants on the trial. When the REST service was used to submit a particular amendment, this option was set to true/yes. It is unknown whether any grants were specified as part of the amendment, but this trial no longer had any grants, so the option was not available. Now the option is available even if there are no grants on the trial. |
| Bug | PO-9538 | NA | In specific situations both restful calls and web application allow entries that appear to display as multiple participating sites | NA | NA |
| Bug | PO-9660 | NA | FTP Upload to ClinicalTrials.gov | NA | Some trials were failing to load and one trial had duplicate sites. |
| Improvement | PO-9666 | PO-9455 | Changes to Results Reporting Dashboard - Clinicaltrials.gov checkin meeting on 2/25 | Tracking and Managing Trial Results v4.4 | This is a Results Reporting Dashboard issue:
|
Role-based Tasks in PA
The CTRO links each PA user's CTRP account with one of the following roles:
- Administrative Abstractor
- Scientific Abstractor
- Admin/Scientific Abstractor
- Super Abstractor
- Results Abstractor
Users can perform only those tasks that are associated with their assigned roles. In some cases the ability to perform a task depends on certain conditions, for example, whether or not the user has checked out the trial.
The following table is a matrix of roles and tasks. A Yes or No in each table cell indicates whether someone with a given role can perform the task.
Role-based Tasks | Admin Abstractor Role / Conditions | Scientific Abstractor Role / Conditions | Admin/Sci Abstractor Role / Conditions | Super Abstractor Role / Conditions | Results Abstractor Role / Conditions |
|---|---|---|---|---|---|
| Perform Scientific Abstraction | No | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Perform Administrative Abstraction | Yes Only when the user has checked out the trial | No | Yes Only when the user has checked out the trial | Yes | No |
Perform Administrative and Scientific Abstraction (simultaneously) | No | No | Yes Only when the user has checked out the trial | Yes | No |
| Validate Trials | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Complete Abstractions | Yes
| Yes
| Yes Only when the user has checked out the trial | Yes | No |
| Manage Accrual Access | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes
| No |
| Process Pending Accruals | No | No | No | Yes | Yes |
| View Audit Trails | Yes | Yes | Yes | Yes | Yes |
| View Check-out History | Yes | Yes | Yes | Yes | Yes |
| View TSRs | Yes | Yes | Yes | Yes | Yes |
| Access Registered User Details | Yes | Yes | Yes | Yes | Yes |
| Process Requests for Admin Rights in the Inbox | Yes | Yes | Yes | Yes | Yes |
| Abstract Trial History | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| View Trial Status | Yes | Yes | Yes | Yes | Yes |
| Update Trial Status | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| View Trial Status History | Yes | Yes | Yes | Yes | Yes |
| Update Trial Status History | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
View Participating Site Status | Yes | Yes | Yes | Yes | Yes |
| View Participating Site Status History | Yes | Yes | Yes | Yes | No |
| Process On-Hold Information | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Process New Marker Requests | No | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | Yes |
| Import Trials from ClinicalTrials.gov | Yes | Yes | Yes | Yes | Yes |
| Associate Trials | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Assign Trial Ownership | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Add Administrative/Scientific Milestones | Yes
| Yes
| Yes Only when the user has checked out the trial | Yes | No |
| Manage Email Notifications | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes Only when the user has checked out the trial | Yes | No |
| Manage Trial Priority | No | No | No | Yes | No |
| Assign Trial for Processing | No | No | No | Yes | No |
| Access the Results Reporting Dashboard | No | No | No | No | Yes |
Creating New CTRP Accounts
Before you request authorization to abstract trials from the CTRO, register for a CTRP account via the NCI CTRP Registration account feature. There are two ways to register for a CTRP account, as follows:
- Via your email address . If you are new to Protocol Abstraction and you do not have an NCI account, you can request one via your email address using the Registration account creation feature.
- Via your NCI credentials. If you are new to Protocol Abstraction and you have an NCI account, create a CTRP account via your NCI credential using the Registration account feature.
Creating New CTRP Accounts via Email
Creating New CTRP Accounts Using NIH or NCI Credentials
Requesting Authorization to Abstract Trials
Contact the CTRO to request a role.
If you have not done so already, contact the CTRO to request authorization to abstract trials, and to request an Administrative, Scientific, Administrative/Scientific, Super, or Results Abstractor role. The CTRO will associate your requested role with your account.
To increase security for the site, you must have a valid NIH LDAP account.
Gather your protocol information before you begin
The system logs you out if it detects that you have not used the application for 30 minutes at any point in the abstraction workflow. The system also locks you out after three unsuccessful attempts to log in within 24 hours. In the event that you cannot remember your password, or have been locked out of your account, contact Application Support at ncicbiit@mail.nih.gov.
Use the CTRP Protocol Abstraction User's Guide to get started
On the menu, click Quick Links > User's Guide.
