How to Abstract Trial Descriptions, Titles, and Identifiers
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, click General Trial Details.
The General Trials Details page appears.
General Trial Details Page, Upper Section – Complete Trial
General Trial Details Page, Upper Section – Abbreviated Trial
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.
You can expand text fields and table cells to reveal all of their content
To increase the size of a text field or table cell, click and drag the lower right corner handle.
Section Field Label
Trial Category (Study Source)
Description/Instructions
NA ClinicalTrials.gov XML required?
Complete
Select the appropriate option to indicate whether an XML document is required to register the trial with ClinicalTrials.gov.
Title Acronym
Complete and Abbreviated
Type the abbreviation (initial letters) by which the trial is known.
Title Official Title*
Complete and Abbreviated
Ensure that the title is accurate and complete (as it appears in the Protocol document). Make any necessary changes or additions.
Alternate Titles Category Complete and Abbreviated
If you discover that there is a spelling or format error in the title as registered in the CTRP, next to Category, select Spelling/Format, enter the corrected title, and then click Add Alternate Title.
If you discover an error that does not fall into the Spelling/Format category, next to Category, select Other, enter the corrected title, and then click Add Alternate Title.
Trial Description Keywords
Complete and Abbreviated
Trial descriptions can contain a keyword or series of keywords that can help to classify the trial. You can enter up to 4,000 characters.
Although Keywords are included in Administrative abstraction, any changes to them (e.g., via an update from ClinicalTrials.gov or the CTRP Registration user interface) require Scientific Acknowledgement.
Other Trial Identifiers Lead Organization Trial Identifier*
Complete and Abbreviated
Enter the ID exactly as it appears in the Protocol document. For Inter-Group trials, type the Lead Group’s trial number. For multi-site trials that have no assigned single center, use the protocol ID.
Example: NSABP-B-40Other Trial Identifiers ClinicalTrials.gov Identifier
Complete and Abbreviated
Enter the trial identifier assigned by ClinicalTrials.gov.
Provide the exact number, including the ClinicalTrials.gov prefix. Example: NCT00012345Other Trial Identifiers CTEP Identifier
Complete
Optionally, in the CTEP Identifier field, type the trial identifier assigned by the Clinical Therapy Evaluation Program.
Other Trial Identifiers DCP Identifier
Complete
Optionally, in the DCP Identifier fields, type the trial identifier assigned by the Division of Cancer Prevention.
Other Trial Identifiers Other Trial Identifier
Complete and Abbreviated
- If appropriate, select either the Obsolete ClinicalTrials.gov Identifier or Duplicate ClinicalTrials.gov Identifier type from the Other drop-down list.
- Enter the trial identifier for the ID type you chose above, or enter another ID, such as a unique identifier from other registries, NIH grant number, or protocol number assigned by the Review Board.
- Click Add Other Identifier. Repeat this step for each additional identifier.
The ID you added is displayed in the Other Identifier list. - To delete an existing identifier, in the Action column, click Delete.
- To edit an existing identifier, in the Action column, click Edit.
Make changes as necessary, and then click Done.
When you save changes to the trial, the system checks the ClinicalTrials.gov Identifier you entered to ensure that no other registered trial has the same one. The system displays an error message if it finds another trial with the same ClinicalTrials.gov Identifier. If this occurs, check the number you entered and try again.
Do one of the following to continue:
If the trial that you are abstracting is an Abbreviated trial, click Save
- or -
If the trial that you are abstracting requires an XML document for submission to ClinicalTrials.gov, complete the Sponsor and Responsible Party and Central Contact sections.
- or -
If the trial that you are abstracting does not require an XML document for submission to ClinicalTrials.gov, complete the Central Contact section.