Page History

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 General Trial Details. The General Trials Details page appears.

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

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   Section Field Label Trial Category (Study Source) Description/Instructions 09 Title Acronym Complete and Abbreviated Type the abbreviation (initial letters) by which the trial is known. 10 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. 11 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. Anchor 6780 6780 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. 12 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.

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   Info 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. 01 Other Trial Identifiers Lead Organization Trial Identifier* Complete and Abbreviated

   Enter

   For instructions on adding or editing an identifier, refer to the steps below this table. Specify 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-40 02 Other Trial Identifiers ClinicalTrials.gov Identifier Complete and Abbreviated For instructions on adding or editing an identifier, refer to the steps below this table. Enter the trial identifier assigned by ClinicalTrials.gov.

   
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   Specify the exact number, including the ClinicalTrials.gov prefix. Example: NCT00012345 03 Other Trial Identifiers CTEP Identifier Complete

   Optionally, in the CTEP Identifier field, type

   For instructions on adding or editing an identifier, refer to the steps below this table. Optionally, specify the trial identifier assigned by the Clinical Therapy Evaluation Program. 04 Other Trial Identifiers DCP Identifier Complete

   Optionally, in the DCP Identifier fields, type

   For instructions on adding or editing an identifier, refer to the steps below this table. Optionally, specify the trial identifier assigned by the Division of Cancer Prevention. 05 Other Trial Identifiers CCR Identifier Complete and Abbreviated For instructions on adding or editing an identifier, refer to the steps below this table. Specify the trial identifier assigned by the Center for Cancer Research. 06 Other Trial Identifiers Duplicate NCI Identifier Complete and Abbreviated

6. If appropriate, select either the Obsolete ClinicalTrials.gov Identifier or Duplicate ClinicalTrials.gov Identifier type from the Other drop-down list.

For instructions on adding or editing an identifier, refer to the steps below this table. If appropriate, specify a duplicate NCI identifier. 07 Other Trial Identifiers Obsolete ClinicalTrials.gov Identifier Complete and Abbreviated For instructions on adding or editing an identifier, refer to the steps below this table. If appropriate, specify an obsolete ClinicalTrials.gov identifier. 08 Other Trial Identifiers Other Identifier Complete and Abbreviated For instructions on adding or editing an identifier, refer to the steps below this table. If appropriate, specify

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.

7. To add each identifier in the Protocol document:
   
   1. From the Other Identifier drop-down list, select the identifier type.
   2. Enter the trial identifier exactly as it appears in the Protocol document.
   3. Click Add Other Identifier.
   Click Add Other Identifier. Repeat this step for each additional identifier.
   
   1. The ID you added is displayed in the Other Identifier list.
8. To delete edit an existing identifier, in the Action column, click Edit. Make changes as necessary, and then click Delete Save.
9. To edit delete an existing identifier, in the Action column, click Edit Delete.

10. Make changes as necessary, and then click Done.

    InfoWhen you save changes to the trial, the

    Click Save. 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.

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    61246124Click Save.

For instructions on completing the remaining sections of the General Trials Details page, refer to the following pages:

• Abstracting Sponsors and Responsible Parties
• Abstracting Central Contacts