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Submitted trials that are ready for validation are listed in search results tables along with trials in other stages of the processing life cycle (Processing Status). You can list only those trials that require validation by limiting your search to trials that have the processing status, Submitted Or, you can sort an existing list of trials by the Action column.

How to Search for Trials that Require Validation

  1. Follow the instructions in Searching for Trials, using only the Processing Status criterion, Submitted.
  2. Select one of the following trial categories from the Search by Trial Category drop-down list on the Trial Search page:
    • To limit your search to Complete trials, select Complete.
      -or-
    • To limit your trial search to Abbreviated trials, select Abbreviated.
      Trials that require validation are listed in the search results table.
  3. In the Action column for the trial you want to validate, click Validate. Or, click the NCI Trial Identifier link.
    The Trial Identification page appears with information about the selected trial. The Validation menu appears with different options depending on whether the trial is Complete or Abbreviated.

    Section
    Column

    Validation menu for Complete trials 

    Validation Menu for Complete Trials

    Column

    Validation menu for Abbreviated trials

    Validation Menu for Abbreviated Trials

How to Sort Search Results by Validation Status

  1. In a search results table from any search, sort the trials by Action. To do so, click the Action column heading.
    The trials are sorted by Action, in ascending order.

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    Search Results table sorted by the Action column
    Search Results – Sorted by Action

  2. Click the Action column heading again to reverse the sort order to display validation-ready trials at the top of the table.

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The final step before accepting or rejecting a trial is to validate the trial details.

How to Validate Trial Details

  1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
  2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.
  3. On the Validation menu, click Trial Validation.

  4. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label

    Instructions

    ClinicalTrials.gov XML required?

    See Abstracting General Trial Details .

    Lead Organization Trial ID*

    Ensure that the ID matches the one provided in the protocol. Make changes as necessary.
    See Abstracting General Trial Details .

    ClinicalTrials.gov Identifier Number

    See Abstracting General Trial Details .

    Official Title*

    Type or correct the trial title as necessary. You can use a maximum of 4000 characters.
    See Abstracting General Trial Details .

    Trial Phase*

    See Abstracting Interventional Trial Design.

    Phase Additional Qualifier

    See Abstracting Interventional Trial Design.

    Primary Purpose*

    See Abstracting Interventional Trial Design.

    Primary Purpose Other Text (available if Primary Purpose = Other)

    See Abstracting Interventional Trial Design.

    Other Identifiers

    See Abstracting Interventional Trial Design.

    Lead Organization*

    See Searching for Organizations.

    Principal Investigator*

    See Searching for Persons.

    Sponsor*

    Validate this section if the trial submitter has indicated that an XML document is required to register the trial with ClinicalTrials.gov.

    Info

    The ClinicalTrials.gov XML Required indicator (true/false) is displayed on the Validate Trial page. To get there, on the Trial Overview menu, click Trial Identification. See Abstracting General Trial Details .

    Responsible Party*

    See Abstracting General Trial Details .

    Responsible Party Email Address*

    See Abstracting General Trial Details.

    Responsible Party Phone Number*

    See Abstracting General Trial Details .

    Data Table 4 Funding Category

    See Abstracting NCI-Specific Information.

    Data Table 4 Funding Source

    See Abstracting NCI-Specific Information.

    Program Code

    See Abstracting NCI-Specific Information.

  5. Do one of the following to continue:
    • To save the trial information so that you can continue to validate the trial at a later time, click Save.
      - or -
    • To put the trial on hold, for example, when you require further information from the submitter, click Place on Hold. See Processing On-hold Information.
      - or -
    • To accept or reject the trial, follow the instructions in Accepting and Rejecting Trials.

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