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This section describes how to ensure that the current trial abstract contains all necessary details. It also provides instructions for correcting any errors that may occur and for viewing abstraction reports.
Main Steps for Validating Trials
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During the process of completing a trial abstraction, the system checks all abstracted data for potential errors and omissions, and all required fields for consistency. For example, it compares the number of arms reported in the interventional trial Design Details with the number of arm records listed on the Arms page.
Major steps for completing an abstraction currently in the "Accepted" or "Abstracted Verified (Response and No Response)" trial processing status are as follows:
- Check the abstract for errors by navigating to the Abstraction Validation page.
- Review any errors/omissions listed on the Abstraction Validation page in order to make corrections as necessary.
- Repeat the validation cycle as many time as necessary.
- View the TSR (Trial Summary Report) and the XML report.
Trial Validation Criteria
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- Brief Title – Brief Titles must be unique for each trial. The system searches all trials with processing status other than Rejected for matching Brief Titles during validation. Brief Titles are case-sensitive but the system does not consider extra spaces in its search for matches.
- Trial Related Documents – Trial must include a single active Protocol document and single active IRB Approval document
- Participating Sites
- Trial must include at least one active participating site in the functional role of participating site
- Each participating site must include at least one active investigator
- Each participating site must have a central or site contact
- Disease/Condition – Trial must include at least one disease/condition
- For studies that have any Trial Status other than "Complete", every linked disease/condition term must be valid and current (not obsolete)
- For trials designated for submission to ClinicalTrials.gov at least one disease/condition must be designated for inclusion in an XML document
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The system displays a warning reminding you to replace an obsolete term with its current equivalent term. |
- Interventions – Interventional trials must have at least one intervention
For studies that have any Trial Status other than Complete, every linked intervention term must be valid and current (not obsolete)
Info The system displays a warning reminding you to replace an obsolete term with its current equivalent term.
- Interventional Trial Design Outcomes – Interventional trials must include at least one primary outcome measure
Person/organization – For studies that have a current Trial Status other than "Complete", each person and organization abstracted must exist in the CTRP system
Info The system displays a warning if a person or organization does not exist in the CTRP system.
- Study Recruitment – Not Yet Recruiting
- Study Start Date can not be in the past
- Site must not be recruiting patients currently
- Review Board Approval correlation with the current Trial Status:
- If the current Trial Status is "In Review", the Board Approval Status must be "Submitted, pending"
- If the current Trial Status is "Disapproved", the Board Approval Status must be "Submitted, denied"
- If the current Site Recruitment Status is "Recruiting", the Board Approval Status can not be "Submitted", "Denied", or "Not Required"
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Additionally, if the trial is designated for submission to ClinicalTrials.gov, the following rules apply:
- The trial must have at least one Responsible Party with contact information
- The trial must have at least one Sponsor or Principal Investigator
- Regulatory information must contain the following:
- FDA Regulated Intervention indicator
- Section 801 Indicator, if applicable
Non-Interventional Trial Groups/Cohorts Criteria
The following rules pertaining to groups/cohorts determine the criteria for completion of non-interventional trials:
- Single-group trials (number of Groups/Cohorts = 1) do not require study group records (on the Groups/Cohorts page) if the trial has either one intervention or no intervention records
- Multi-group trials (number of Groups/Cohorts > 1)
- Require one or more Group/Cohort records (on the Groups/Cohorts page)
- The number of study group records (on the Groups/Cohorts page) must be the same as the number of groups indicated on the Design Details page
- Each intervention must be associated with a group/cohort
Trial Reporting
Upon trial abstraction validation or abstraction update, you can send a trial summary report that includes the summary of the abstraction and an XML file that contains abstracted trial records formatted for submission to ClinicalTrials.gov.
Attached to the message are two system-generated reports as follows:
- Trial Summary Report (TSR) – System-generated report that presents all abstracted data in an easy-to-read format
- XML File – System-generated report that contains abstracted data in the format suitable for submission to ClinicalTrials.gov. This document is sent only to trial submitters who indicated that an XML file is required for submission to ClinicalTrials.gov.
The message instructs the submitter to review the TSR for accuracy and to report any changes to the CTRO staff.
Validating Abstractions
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As soon as you click Abstraction Validation on the main menu, the system scans the abstracted information for errors and omissions automatically. You must correct all errors before completing the abstraction.
How to Validate Abstractions
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The system lists error messages in the order in which they appear in the abstraction workflow. The workflow follows the order of features displayed in the main menu. For example, the system lists Administrative Abstraction errors before Scientific Abstraction errors; and General Trial Detail errors before Participating Sites errors. |
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If the Abstraction Validation page contains error/omission records, correct them according to the instructions in the Comment column and specific instructions included throughout this guide, and then proceed to the next step. For example, if validation failed due to Trial Status errors, navigate to the Administrative Data section on the main menu, click Trial Status, and then click Trial History to make the corrections.
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Optionally, if the Abstraction Validation page does not contain error/omission records, click View TSR or View XML to review the Trial Summary Report (TSR) or XML file.
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