Abstracting NCI-Specific Information - Include 20170828

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. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. 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.  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.

5. On the NCI Specific Information page, in the various fields, specify 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 This field does not reflect the trial category, even though it uses similar terminology.
   Data Table 4 Funding Category	Select one of the following trial types based on the role/responsibility/participation in the study. Trials are categorized by type of Data Table 4 Funding Sponsorship or Trial Submission Category (study source).   Complete Trials: National: NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks. Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or organizations on this list: Organizations with Peer Review Funding Systems. Institutional: In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer review solely by the Protocol Review and Monitoring System of the Cancer Center. The Cancer Center investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results. It is acceptable for industry and other entities to provide support (such as drug, device, or other funding), but the trial should clearly be the intellectual product of the center investigator. This category may also include: Institutional studies authored and implemented by investigators at another Center in which your Center is participating. Multi-Institutional studies authored and implemented by investigators at your Center. (Note: National and externally peer-reviewed studies should be listed with those categories, not as Institutional studies.) Abbreviated Trials: Industrial: A pharmaceutical company controls the design and implementation of these clinical research studies. 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 .) A trial can have multiple sponsors. The system ensures that you don't duplicate an existing sponsor. 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. 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. 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.
   NIH/NCI Division/Department Identifier	Select the division or department that is managing the trial.
   NIH/NCI Program Identifier	Select  the relevant program.

6. Optionally, to view the details of the Data Table 4 Funding Sponsor/Source (if already recorded), click the Details icon ().

   Displaying Organization and Person Details

   You can display the details of any organization or person, including their CTEP and PO IDs, that appears on abstraction pages by clicking the Details icon () located next to an organization or person name field.

7. 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.