The Clinical Trials Reporting Office (CTRO) reviews each trial submitted to the system in order to validate submitted information. During the validation process, the reviewers check for duplicate records and ensure that the submitter has provided all required information. CTRO does one of the following as part of the validation/abstraction process:
- If all data is complete and accurate, the reviewers assign the trial the status "Accepted," and the system notifies the submitter by email.
- If information is missing, or there are discrepancies in the information provided, the reviewers can place a trial on hold. The CTRO contacts the submitter for clarification and/or to request missing documents, and resumes processing once the trial is validated.
- If the trial is a duplicate (i.e., another user has submitted the same trial), the reviewers assign the trial the status "Rejected," and the system sends the submitter an email message indicating the status and reason for the rejection. Reviewers may also reject a trial if CTEP/DCP/CCR has approved the trial. NCI transfers these trials internally.
If you have questions about a rejected trial, contact the CTRO at ncictro@mail.nih.gov.
The trials that match your search criteria are listed in search results tables. Which of the search results are displayed is determined by the following criteria:
- Processing status of the trial at the time of the search. Trial statuses are listed and defined in Trial Processing Statuses.
- Submitted - Original trial submitted but not validated
- Amendment Submitted - Amendment submitted but not validated
- Accepted - Trial passed validation
- Rejected - Trial did not pass validation. These trials are not displayed.
- Abstracted - Trial has been abstracted
- Verification Pending - Trial has been abstracted, and the Trial Summary Report (TSR) has been sent to the trial submitter for abstraction verification
- Abstraction Verified Response - Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days after receiving the TSR
- Abstraction Verified No Response - Submitter has not responded or returned verification feedback to the CTRO within five business days after receiving the TSR
- User's role with respect to the trial. User roles include the following:
- Site Administrator - Has full access to the trials led by the organization (plays lead organization role)
- Trial Submitter/Owner - Has full access to the trials they own or submitted
- Other user - Any user other than the trial submitter, owner, or trial's lead organization system administrator
- Trial ownership. Trial ownership types are as follows:
- Private trials - Trials submitted or owned by the user who is currently logged in to Registration
- Public trials - Trials submitted by other registered users
To navigate the search results table, see Working with Tables and Search Results.
Trial records returned from "Search My Trials" and "Search All Trials" options display the following details and actions you can take for each trial when applicable.
No data are displayed for Private trials with a processing status of Rejected nor for Public trials with a processing status of Submitted or Rejected.
The following table describes the columns in the search results table:
Column | Displayed for Public trials? | Description |
|---|---|---|
NCI Trial Identifier | Yes | Unique identifier assigned to the trial by the CTRP |
Title | Yes | Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document) |
Lead Organization | Yes | Organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial |
Lead Org (Organization) Trial Identifier | Yes | Unique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number. |
Principal Investigator | Yes | Appointed investigator responsible for conducting the clinical trial, or, for multi-site trials, the study chair |
ClinicalTrials.gov Identifier | Yes | unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678). |
Other Identifiers | Yes | Identifiers other than Lead Organization Trial Identifier or ClinicalTrials.gov Identifier |
Current Trial Status | Yes | Code that represents the status of a trial in relation to the ability to enroll participants/patients |
Current (Trial) Processing Status | No | Stage in the trial processing work flow |
Available Actions | Yes | Actions that are applicable to the trial according to the processing rules
|
| Accrual Disease Terminology | No | The disease terminology currently in use for accruals. You can select a new terminology from the drop-down list only if the trial has not accrued patients. Additionally, you can change accrual disease terminology at any time for trials currently recording accruals at the summary level only. |
(Participating) Sites | Yes | One or more organizations participating in the trial. Click View in the Sites column to view participating site details. |
Phase | No | Phase of the investigation, as defined by the US FDA for trials involving investigational new drug |
Primary Purpose | No | Main purpose of the trial |
Category | No | Data Table 4 Funding Sponsorship or Trial Submission Category |
Trial Start Date | No | Date on which the trial starts |
Responsible Party | No | Responsible party, as defined by FDAAA |
Sponsor | No | Primary organization that oversees the implementation of the study and is responsible for data analysis as defined in 21 CFR 50.3 |
Data Table 4 Funding Sponsor Type | No | Trial category selected for trial submission |
Record Verification Date | No | Date on which the CTRO validated the trial submission |
Submitter | No | Name of person who submitted the trial |
Primary Completion Date | No | Date on which the trial reaches/reached its primary completion date |
Last Update Submitted | No | Date on which the trial was last updated |
| Last Updater Name | No | Name of the person who last updated the trial |
Last Amendment Submitted | No | Date on which the trial was last amended |
Last Amender Name | No | Name of person who amended the trial |
On-Hold Reason | No | Reason why the trial was placed on hold |
Trial records returned from "Search Saved Drafts" display the following details and actions you can take for each trial when applicable:
| Column | Description |
|---|---|
| Temporary Trial Identifier | Unique identifier that the system assigned to the saved draft |
| Title | Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document) |
| Lead Organization | Organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial |
| Lead Organization Trial Identifier | Unique identification assigned to the protocol by the sponsoring organization. Multiple studies conducted under the same grant must each have a unique number |
| Action |
|
Trial ownership and current processing status determine which of the trial details and actions listed above are displayed in the Search Results table. Refer to Trial Processing Statuses.
