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NCI-Specific Information applies to Complete and Abbreviated trials. For Abbreviated trials, indicate whether or not the trial is Industrial.

Included in this section is the option, for certain trials, to include them in, or exclude them from, the batch of trials that CTRP sends to ClinicalTrials.gov via FTP nightly.

How to Abstract NCI-Specific Information

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

2. On the Administrative Data menu, click NCI Specific Information. The NCI Specific Information page appears. It displays different fields according to the trial's Data Table 4 category (study source) and the criteria described in the matrix in Conditions for Sending Trial Information to ClinicalTrials.gov. 
   

   Include Page
   Display Organization and Person Details - Include v4.4 Display Organization and Person Details - Include v4.4

   
   

    

   The following factors determine which fields appear on this dialog box:

   • If the lead organization for the trial belongs to an organization family, the Program Code field is available. The Program Code field lists all program codes available for that organization family.
   • CTRP does not send Abbreviated trials in the batch files, and therefore does not display the option to indicate whether to send the trial.
   • For a Complete trial that has been sent to ClinicalTrials.gov in the batch files previously, CTRP does not display the option to indicate whether to send the trial in the future.
   • For a Complete, NCI-sponsored trial, CTRP displays the option to indicate whether to send the trial in the future and the Comments field. The default setting for this option depends on whether the trial has been sent to ClinicalTrials.gov previously:
     
     • For an original submission (which therefore has not been sent to ClinicalTrials.gov previously), the option to indicate whether to send the trial defaults to Yes, but CTRP displays the option to exclude the trial in the future.
     • For a trial that may have been updated and that had not been sent to ClinicalTrials.gov when submitted originally, it defaults to No, but CTRP displays the option to send the trial in the future.

3. 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	Description/Instructions
   Reporting Data Set Method*	Specifies how CDUS accruals are submitted to CTEP. Select one of the following methods used for the principal investigator summary report:  Abbreviated - Requires minimal subset of data for reporting (for example, demographics) Complete - Larger set of data (for example, includes outcomes) AE (Adverse Events). Adverse events statistics are reported Info This field does not reflect the trial category, even though it uses similar terminology.
   Data Table 4 Funding Category	Select one of the following types of external sponsor or funding source (study source) trial types based on the role/responsibility/participation in the study:. Include Page Trial Categories - Include v4.4 Trial Categories - Include v4.4 Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 and For more information, refer to http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information.
   Data Table 4 Funding Sponsor/Source	To add a sponsor, click Add Sponsor and search for the name of the external sponsor or funding source as defined by the Data Table 4 report. (See Searching for Organizations .) Info A trial can have multiple sponsors. The system ensures that you don't duplicate an existing sponsor. Anchor 5424 5424 Anchor 7098 7098 To delete an existing sponsor, click Delete Sponsor. You can not "undo" the deletion but you can add the sponsor back if necessary. Refer to http://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4 and http://cancercenters.cancer.gov/GrantsFunding/eData#dt4 for further information about specific Funding Sponsors.
   Industrial?	For Abbreviated trials, indicate whether the trial is an Industrial trial, or other category, according to the matrix in Industrial? Values. Anchor PO-5365 PO-5365 Because most Abbreviated trials are Industrial, the default value during trial registration is "YES". For Consortia trials, select one of the other values.
   Program Code	The Program Code field lists all program codes available for the organization family of the lead organization. Select one or more program codes. The program codes are generally entered by the trial submitter. To view or modify a different family's program codes, refer to the Registration Site Administration chapter of the Registration User's Guide.
   Send Trial Information to ClinicalTrials.gov?	For Complete trials, select one of the following to indicate whether to send the trial information to ClinicalTrials.gov in the automated nightly batch updates (via FTP): Yes. Trial will be sent. No. Trial will not be sent. Anchor 8120 8120 Info If you select Yes, the CTRP system sends the information to ClinicalTrials.gov. If PRS indicates to the CTRP system that it processed the trial successfully, the CTRP system does not display this option in the future for this trial. For further information about this field, see Conditions for Sending Trial Information to ClinicalTrials.gov.
   Comments	Enter a comment about your selection.

4. Optionally, to view the details of the Data Table 4 Funding Sponsor/Source (if already recorded), click the Details icon ().
5. To save the details you have abstracted, click Save.

Industrial? Values

For Abbreviated trials, indicate whether the trial is an Industrial trial or other category, according to the Data Table 4 Category values below. The Consortia Trial Indicator is internal to the CTRP system.

Conditions for Sending Trial Information to ClinicalTrials.gov

Following are the inclusion criteria the system uses to determine the set of CTRP trials to send to ClinicalTrials.gov:

1. The trial is NCI Sponsored. Trials are funded under an N01/N02 contract or have an IND held by CTEP, where NCI is listed as the sponsor.
   AND

2. Has been fully abstracted.
   AND
3. The Send Trial Information to ClinicalTrials.gov field is set to Yes. 

The System will exclude from sending all trials that meet one or more of the following criteria:

1. Observational trials.
   OR
2. Industrial trials.
   OR
3. Trials with the Send Trial Information to ClinicalTrials.gov field set to No.
   OR
4. CCR trials.