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This page tree describes how to abstract and edit the scientific details of clinical trials.

About Scientific Data

You can edit or add most trial-related scientific information except codes and other identifiers that the system generates, such as the NCI Trial Identifier.
Scientific information for trials comprises the following:

• Trial descriptions
• Trial design, including design details, outcome measures, and eligibility criteria
• Diseases and conditions
• Data Table 4 anatomic sites
• Biomarkers (Markers)
• Interventions
• Arms for Interventional trials
• Groups and cohorts for Non-interventional trials
• Sub-groups

After a trial has been accepted, if you log in with an appropriate role, the Scientific Data menu contains an option for each of the above categories.

The trial summary remains displayed at the top of each page as you navigate through the Scientific Data section.

Abstracting Trial Descriptions

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Trial descriptions include the following information:

• Brief title
• Brief summary

Additionally, they may include a detailed description.

How to Abstract Trial Descriptions

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Abstracting Interventional Trial Design

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How to Abstract Interventional Trial Design Details

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

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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.

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Trial Details

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Instruction

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Primary Purpose*

1. Select the primary reason for conducting the trial. The following list provides valid values.

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2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.

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1. Select one of the following reasons for conducting the trial.

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2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.

Trial Phase*

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1. Select the current phase of the trial. The following list provides valid values.

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2. If the trial phase is N/A, indicate whether the trial is a pilot by selecting Yes or No from the Pilot Trial? drop-down list.

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Intervention Model*

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Number of Arms*

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Masking*

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Masking Role(s)*

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• Subject
• Investigator
• Caregiver
• Outcomes Assessor

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Allocation*

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Study Classification

Select the type of primary outcome or endpoint that the trial is designed to evaluate.

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Target Enrollment*

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Abstracting Non-Interventional Trial Design

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How to Abstract Non-Interventional Trial Design

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

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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.

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Select Non-Interventional. (Selected by default)

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Select one of the following trial types:

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Primary Purpose*

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1. Select the primary reason for conducting the trial. The following list provides valid values.

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2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either Observational or Ancillary -Correlative , in the text field.

Trial Phase*

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1. Select the current phase of the trial. The following list provides valid values.

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1. Select the primary strategy for subject identification and follow-up. The following list provides valid values.

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1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.

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Select the DNA retention indicator from one of the following:

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Target Enrollment*

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Abstracting Outcomes

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Adding Outcome Measure Records

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How to Add Outcome Measures

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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.

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Field

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Instruction

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Outcome Measure Type*

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Select the type of outcome measure from the drop-down list. Valid values are as follows:

• Primary. Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
• Secondary. Secondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
• Other Pre-specified. Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
  

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Title*

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Enter a concise name for the specific measure that will be used to determine the effect of the intervention(s) or, for observational studies, related to core objectives of the study and receiving the most emphasis in assessment.

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Time Frame*

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Enter the time point(s) at which outcome measure is assessed. For example, collected every 28 days.

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Description

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Enter additional information about the outcome measure, if needed for clarification.

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Safety Issue*

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Editing Outcome Measures

You can modify existing outcome measure records during abstraction.

How to Edit Outcome Measures

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Outcome Measures. The Outcome Measures page displays one or more outcome measure records.
3. In the Edit column for the record you want to modify, click the Edit (pencil) icon.
   The  Add/Edit Outcome Measures page appears.
4. Modify the information, and then click Save.

Reordering Outcome Measures

You can change the order in which the outcome measure records are displayed in the Outcome Measures table and in the TSR/XML documents.

How to Re-Order Outcome Measure Records

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Outcome Measures. The Interventional Trial Design – Outcome Measure page appears, displaying Outcome Measures currently abstracted.
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3. Click and drag the record you want to move to a new location in the Outcome Measures table. The record background changes to grey as you move the record. Image Removed

Copying Outcome Measures

You can copy existing outcome measure records during abstraction to facilitate recording variations of attributes for the same measure.

How to Copy Outcome Measures

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Outcome Measures. The  Outcome Measures page displays one or more outcome measure records.
3. Click the Copy icon (Image Removed).
   The  Add/Edit Outcome Measures page is displayed with the fields populated with information from the copied record.
4. Enter the information for the marker variation, and then click Save.

Deleting Outcome Measures

You can delete existing outcome measure records during abstraction. However, each trial must have one primary outcome measure.

How to Delete Outcome Measures

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Outcome Measures. The Outcome Measures page displays one or more outcome measure records.

3. In the Delete column, select the check box for each record you want to delete, and then click Delete. To delete all records, click Select All, and then click Delete.

   Warning
   title Warning
   There is no way to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Outcome Measures.

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Abstracting Eligibility Criteria

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Eligibility criteria include a set of demographic information (i.e., health, gender, age) and other eligibility criteria in a table consisting of both “Inclusion” and “Exclusion” criteria.

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Abstracting Interventional Trial Eligibility Criteria 

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How to Abstract Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design, click Eligibility Criteria. The Interventional Trial Design – Eligibility Criteria page appears.
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   If the trial has been abstracted previously, the Eligibility Criteria section displays the demographic eligibility elements. The Other Criteria section may also display inclusion and/or exclusion criteria that have been added previously (see Adding Other Eligibility Criteria).

3. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.

   Field	Instruction
   Accepts Healthy Volunteers*	If the trial accepts healthy participants, select Yes. Otherwise, select No.
   Gender*	Indicate the gender criteria by selecting either Female, Male, or Both.
   Minimum Age*	Enter the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.
   Maximum Age*	Enter the maximum participant age. If there is no maximum age, type 999 , and select Years from the Unit drop-down list.
   Unit*	Select the age unit from the drop-down list. Valid values are as follows: Years Months Weeks Days Hours Minutes

   Tip
   title You can expand the Other Criterion table columns to read full criteria descriptions and names
   To increase the size of a description or name cell, click and drag the lower right corner handles. Image Removed Original cell size with hidden text Image Removed Expanded cell revealing all text

4. Click Save.
   The trial is updated with the information you provided, and a new interface appears which enables you to add other criteria. See Adding Other Eligibility Criteria.

Editing Demographic Eligibility Criteria

How to Edit Demographic Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.
3. Modify the information as necessary, and then click Save.

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Abstracting Non-Interventional Trial Eligibility Criteria

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How to Abstract Non-Interventional Trial Eligibility Criteria

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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All fields are required.

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Field

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Instruction/Description

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Accepts Healthy Volunteers*

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If the trial accepts healthy participants, select Yes. Otherwise, select No.

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Gender*

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Indicate the gender criteria by selecting either Female, Male, or Both.

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Minimum Age*

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Type the minimum participant age. If there is no minimum age, type 0 , and select Years from the Unit drop-down list.

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Maximum Age*

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Type the maximum participant age. If there is no maximum age, type 999 , and select Years from the Unit drop-down list.

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Unit*

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Select the age unit from the drop-down list. Valid values are as follows:

• Years
• Months
• Weeks
• Days
• Hours
• Minutes

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Describe the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).

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Adding Other Eligibility Criteria

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How to Add Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears. If the Add Another Criterion button is not displayed, complete all demographic fields on the Eligibility page first.
3. Click Add Another Criterion.
   The Add/Edit Eligibility Criterion Page appears.
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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	Instruction/Description
   Eligibility Criterion Type	Indicate whether satisfying the criterion qualifies or disqualifies a subject from participation in the trial by selecting Inclusion or Exclusion respectively.
   Structured or Unstructured*	The Unstructured option is preselected. This is the only method by which you can record eligibility criteria via Protocol Abstraction.
   Eligibility Criterion Description*	Enter a comprehensive description of the criterion.

5. Click Save.
   The new criterion record is displayed on the Eligibility Criteria page.

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Editing Other Trial Eligibility Criteria

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Reordering Other Eligibility Criteria

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You can change the order in which the eligibility criteria are displayed in the criteria table and in the TSR/XML documents.

How to Re-Order Other Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears, displaying all other eligibility criteria currently abstracted.
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3. Hover your mouse in the Eligibility Criterion Type column.
   The cursor changes shape.
4. Click and drag the record you want to move to a new location in the Other Criteria table. The record background changes to grey as you move it.
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Deleting Eligibility Criteria

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Although you cannot delete the demographic fields, you can delete other criteria records that may have been added during abstraction.

How to Delete Eligibility Criteria

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, under Interventional Trial Design or Non-interventional Trial Design, click Eligibility Criteria. The Eligibility Criteria page appears.

3. In the Delete column for the record you want to delete, click the Delete icon.

   Warning
   title Warning
   There is no way to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Other Eligibility Criteria to add it back.

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Abstracting Diseases and Conditions 

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You can search for and select disease and condition terminology from a stored list of active disease/conditions in the NCI Enterprise Vocabulary Service's (EVS) NCI Thesaurus (NCIt). You can find more information about the NCIt at http://ncit.nci.nih.gov/.

Trials can have multiple disease records. Each record displays the following information about the disease or condition:

Disease and condition data definitions

You can view, edit, delete, and add diseases/conditions to the trial.

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Viewing Diseases and Condition Details

You can view the details of each disease/condition linked to a trial, super- and sub-concepts, and parent/child (vertical) hierarchical relationships.

How to View Disease/Condition Details

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Disease/Condition. The Trial Disease/Condition appears.

3. In the View Details column for a given record, click the View icon.
   The Disease/Condition Details Window appears.
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   The Disease/Condition Details window displays the following details:
   Disease and condition data definitions

   Column Name	Definition
   Preferred Name	Word or phrase that the NCIt uses by preference to refer to each disease/condition.
   Code	NCIt unique identifier (code) assigned to each disease/condition.
   NCI Thesaurus Concept ID	A concept unique identifier in the NCIt.
   Display Name	The name that is used in the “reported” diseases domain. Some diseases are reported and therefore are included in the “reported” disease hierarchy. Others are too specific to report and are not included in the 'reported' disease domain. Info The name of a “reported” disease in the domain can differ from the preferred name.
   Other names	Synonyms of the preferred name.
   Super-concepts	Concepts in the hierarchy above the disease/condition concept. Also known as “parents”. Each super-concept may have its own parent concept.
   Sub-concepts	Concepts in the hierarchy below the disease/condition concept. Also known as “children”. Each sub-concept may have its own child concept.

4. When you have finished viewing the details, click Close.

Adding Diseases and Conditions

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How to Add Diseases to a Trial

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Click Add.

The Disease dialog box appears, with the Find a Disease/Condition section.
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• To search for alternate (synonymous) terms, select the Search Synonyms check box. The system searches for your preferred term and for alternate terms as well.
• To limit your search to exact matches only, select the Exact match only check box. The system searches for terms that exactly match what you typed.
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To add diseases/conditions, click the desired disease/condition from the list of search results or from the CTRP Disease Hierarchy window. Or, to add all of the diseases/conditions, next to the Search field, click Add All.
The diseases/conditions you choose appear in the Your Selections box.

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1. To remove a term from the Your Selections box, click the Remove icon associated with the term.
2. To remove all search terms and selections, click Reset.

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Editing Disease and Condition Indicators - Changing the XML Inclusion Indicator

You can change the Include in XML indicator for current records in a given trial.

How to Edit Disease/Condition Indicators

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Disease/Condition. The Trial Disease/Condition page appears, with disease or condition records displayed.
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3. Click the Edit icon.
   The Edit Disease/Condition page appears.
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4. To include or exclude the disease/condition in the XML document for submission to ClinicalTrials.gov, select or clear the Include in XML check box respectively.
5. Click Save.
   The edited record is displayed on the Disease/Condition page.

Deleting Diseases and Conditions

The system removes records from view when you delete diseases or conditions from a trial, but it does not delete them from the system. However, there is no way for you to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Diseases and Conditions to add it back.

How to Delete Diseases/Conditions from a Trial

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Disease/Condition. The Trial Disease/Condition page appears.
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3. Do one of the following:
   
   • In the Delete column for the appropriate record, select the Delete check box, and then click Delete.
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   • To delete all records, click Select All, and then click Delete.

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Managing NCIt Disease/Condition Terms

You can import NCIt terms on demand if the term you require for abstraction does not exist in the CTRP database. Once imported, CTRP syncs the term with in the NCIt database automatically.

If a term does not exist (i.e., has not been published yet) in the NCIt, you can request the term directly from EVS. Once EVS curators have responded to your request, you can enter new term details when abstracting trials. Later EVS publishes the new term in the NCIt. Refer to Managing Disease and Intervention Terminologies.

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1. At the bottom of the Disease/Condition page, click Manage NCIt Terms.
   The Manage NCIt Terms menu contains options for managing disease terms.
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2. Follow the instructions in the following sections:

• Importing Disease/Condition Terms
• Synchronizing Disease/Condition Terms
• Requesting New Disease/Condition Terms
• Entering Disease/Condition Terms
  

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Abstracting Data Table 4 Anatomic Sites

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You can select and record anatomic site terms that identify the anatomic cancer site(s) on which a trial or study is focused. These records are included in a Data Table 4 report. A trial can have multiple anatomic sites.

Adding Data Table 4 Anatomic Sites

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How to Add Data Table 4 Anatomic Sites

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Data Table 4 Anatomic Site. The Data Table 4 Anatomic Site page appears, with or without any anatomic records displayed.
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   Data Table 4 Anatomic Site Page
3. To add a site, click Add.
   The Add Data Table 4 Anatomic Site page appears.
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4. Select the anatomic site from the drop-down list.
5. Click Save.
6. If applicable, repeat the steps above to record additional sites.

Deleting Data Table 4 Anatomic Sites

How to Delete Data Table 4 Anatomic Sites

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Data Table 4 Anatomic Site. The Data Table 4 Anatomic Site page appears.
3. Do one of the following:
   
   • To delete one or more sites, in the Delete column for the appropriate record(s), select the check box, and then click Delete.
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   • To delete all records, click Select All, and then click Delete.

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Abstracting Biomarkers

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The abstraction of biomarkers applies to Complete and Abbreviated trial categories. You can record biomarkers, their classification, and purpose. Biomarkers for a given study may be available from the study protocol documents. You can search caDSR for biomarkers. If you do not find the biomarker in the caDSR, you can create a placeholder entry for the biomarker named in the protocol.

Adding Biomarkers

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A trial can have multiple biomarker records. You can add them individually, or copy the marker records as you create them to enter variations of attributes (e.g., multiple assay types) for the same marker.

How to Abstract Markers

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Search for and select the biomarker from the caDSR by following the instructions in Searching for Biomarkers in caDSR.

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Select the appropriate attributes. The following table describes the fields. An asterisk (*) indicates a required field.

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Trial Description

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Instruction

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Click caDSR and follow the instructions in Searching for Biomarkers in caDSR. If you cannot find the biomarker indicated in the protocol document in caDSR, enter the biomarker name directly in the Name field to create a placeholder value.

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Assay Type* (CDE ID 64731)

Select the test type(s), the test name(s), or method(s) used to assess a specific marker. Valid values include:

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Biomarker Use* (CDE ID 2939411)

Select the value that describes the assay use. Valid values include:

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Biomarker Purpose* (CDE ID 2939397)

Select the value(s) that describes the reason or intention of the assay in the clinical study. Valid values include:

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Specimen Type* (CDE ID 3111302)

Select the type(s) of sample. Valid values include:

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Record Status

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• Scroll to the top or bottom of the page, and click Save.

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• To create a new record for a different marker but with the same attribute selections, click Save & Retain Attributes. Then search for and select the biomarker from the caDSR, and save the record.

The Marker page displays the record(s) you created.

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Searching for Biomarkers in caDSR

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• Search Term. Search for biomarkers meanings that contain the search term
• Search Scope. Search for biomarkers that contain the search term in their preferred permissible values only, in their synonyms (alternate names) only, or in both (the default).
  
• Public ID. Search for biomarkers by their Public IDs only
  

Additional search options include the following:

• Case-sensitivity. You can elect to make the search term case-sensitive or insensitive. Searches are case-insensitive by default.
• Highlighting search terms. Query text in search results is highlighted by default to make search terms easier to identify. You can turn on or off query text highlighting in the search results.

Most search results list primary terms followed by all possible synonyms in parenthesis in the following order:

• Exact matches for the Primary term
• Matches that contain the search term alone (i.e., the term is not part of a larger term)
• All other matches that contain the search term

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How to Search for Markers in caDSR

1. Follow Steps 1 and 2 in Adding Biomarkers.
2. Next to the Name field, click caDSR
   The Marker Search in caDSR window appears.
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3. Enter all or part of the criteria for the search in the fields provided.

4. To restrict your search by case, next to Case-Sensitive Search, select Yes (the default is case-insensitive).

5. To highlight the term you searched for in the list of results, next to Highlight Query Text, select Yes.

6. Press the ENTER key on your keyboard, or click Search.

7. The results of your search are listed in a table with their permissible values

   Footnote
   The TSR document associated with a trial includes both the permissible value and alternates (synonyms).

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8. In the row that contains the appropriate marker, click Select.
   You are returned to the Add Marker page. The Marker Name field is populated with information from the marker you selected.

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Adding Biomarkers from HUGO to the caDSR Database

If you did not find a given biomarker in caDSR, The Research Scientist must review the term to determine if a request must be sent to caDSR. If the marker is a gene, the Research Scientist should access HUGO (via the link in the request form). The HGNC-approved symbol should be requested as the primary term, followed by any appropriate synonym from the protocol in parenthesis. The HGNC ID number should also be included in the request after selecting the Found in Hugo? check box.

How to Request Markers from HUGO for Addition to the caDSR Database

1. Follow Steps 1 and 2 in Adding Biomarkers.
2. Next to the Name field, click caDSR
   The Marker Search in caDSR window appears.
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3. Click Create Biomarker Request.
   The Create Permissible Value Request window appears, with your email address in the Sender's Email address field.
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4. Select the Found in HUGO? check box, and then click the HUGO link.
   The window displays a new field for the HUGO marker code, and the HGNC database is launched in a new browser window.
5. Search for the marker in the HGNC database, and then enter the HGNC ID number for the appropriate record into the Hugo Marker Code field. This field is displayed only when you select the Found in HUGO? check box.
6. In the Text of marker as written in the protocol field, copy and paste, or enter, the information about the marker as it appears in the protocol.
7. Click Send Email.
   Your request is sent to the caDSR for processing. The value you requested is listed on the Pending Markers Report with the Pending status. You can return to the Pending Markers report later to enter the Public ID number once caDSR has sent notification to the Research Scientist that the new term was created. (See Processing New Biomarker Requests.)

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Editing Biomarkers

You can change recorded marker information or delete marker records from a trial.

How to Edit Marker Records

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Deleting Biomarkers

You can delete one or more marker records from a trial.

How to Delete Marker Records

1. Do one of the following to select the markers you want to delete:
   
   1. To delete a marker(s), select the check box in the Delete column for the appropriate marker record(s). You can select multiple records.
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   2. To delete all markers, click Select All.
      The button changes to Deselect All.
2. Optionally, to clear all check boxes, click Deselect All.
3. Click Delete, and then confirm that you want to delete the record.

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Requesting New Permissible Values for Biomarkers

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How to Request New Permissible Values for Biomarkers

1. Follow Steps 1 and 2 in Adding Biomarkers.
2. Next to the Name field, click caDSR
   The Marker Search in caDSR window appears.

3. Click Create Biomarker Request.

   The Create Permissible Value Request window appears, with your email address in the Sender's Email address field.

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4. In the Marker Name field, enter the most appropriate biomarker name followed by the name as it appears in the protocol in parenthesis if the two are not identical.
5. In the Text of marker as written in the protocol field, copy and paste, or type, the information about the marker as it appears in the protocol.
   Click Send Email.
   Your request is sent to the caDSR for processing. The value you requested is listed on the Pending Markers Report with the Pending status. You can return to the trial later to accept it once it has been processed. (See Processing New Biomarker Requests.)

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Abstracting Interventions

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You can search for, and select, interventions from a stored list of active intervention terms extracted from NCIt and link them to a trial. NCIt is an online database developed and maintained by the National Cancer Institute Enterprise Vocabulary Services. You can find more detailed information about NCIt at http://ncit.nci.nih.gov/.

Additionally, Protocol Abstraction provides a structure for describing drug, radiation, and surgical procedure details. It generates a description from values you provide for such parameters as dose, target site, frequency of administration, etc.

Trials can have multiple intervention records. Each record displays the following information about the intervention:

Intervention data definitions

Additionally, you can add, edit, reorder, and delete records.

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 Adding Interventions

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You can link interventions to a trial by searching for an intervention name from the current list of active records.
The terminology list is refreshed weekly.

How to Add Interventions

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Click Add. The Add intervention page appears.
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In the Intervention Name field, type part or all of the intervention name.

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1. To include synonyms in your search in addition to preferred names, select the Include Synonym check box.
2. To limit your search to exact matches only, select the Exact Match Only check box.

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Optionally, in the Intervention Description field, enter the name/description of the intervention. 

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Generating Drug, Radiation, Procedure, and Surgery Descriptions

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Protocol Abstraction provides a structure for abstracting detailed descriptions of drug, radiation, and procedure/surgery interventions.

How to Generate Drug, Radiation, and Procedure/Surgery Descriptions

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears, with or without any intervention records displayed.
3. Click Add. The Add intervention page appears.

4. From the Intervention Type field, select Drug, Radiation, or Procedure/Surgery as appropriate.

   Tip
   title Tip
   Do not type an intervention description at this point. The system automatically populates the Intervention Description from information you provide in the next steps.

5. Follow the steps in Adding Interventions for instructions for searching for, and selecting, interventions.
   The Interventions page expands to display a Drug Information, Radiation, or Procedure Information section, depending on your selection.
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6. In the Drug, Procedure, or Radiation Information section of the page, enter the values in the text fields provided.
7. To provide values for the parameters that require harmonized terms (the gray fields), click Look Up.
   The Search window appears .
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8. Type your search criteria in the field(s) provided, and then click Search. If the information you are abstracting includes a range, for example, dose range, you can provide the lower limit without providing the upper limit. However, do not provide the upper limit of a range unless you also include a lower limit.

   Info
   You must type at least one character in any of the search fields.

   The Search window displays the result(s) of your search.
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9. In the search results list, locate the preferred item, and then click Select.
10. Once you have provided information for all relevant fields, click Generate.
    The information you provided is displayed in the Intervention Description field.
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11. Click Save.

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Editing Interventions

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You can edit trial descriptions. However, if you need to change the intervention type or name, you must delete the record and create a new one with the correct information. See Deleting Interventions.

How to Edit Intervention Records

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Interventions page appears.
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3. In the Edit column for a given record, click the Edit (pencil) icon.
   The Edit Intervention page appears.
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4. Edit or enter the intervention description, and then click Save.
   If you edit a drug, radiology, or procedure intervention, the Edit Intervention page displays the original form for the record.
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5. To edit the intervention description and/or details of drugs, radiation, and procedures/surgeries, follow the instructions in Adding Interventions.
6. Click Save.

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Reordering Interventions

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You can change the order in which the interventions are displayed in the interventions table and in the TSR/XML documents.

How to Re-Order Intervention Criteria

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Deleting Interventions

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When you delete interventions from a trial, you delete them from view, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Interventions to add it back.

How to Delete Interventions

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Interventions. The Intervention page appears.
3. In the Delete column, select the check box for each record you want to delete, then click Delete. To delete all records, click Select All, and then click Delete.

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Managing Intervention Terms

You can import NCIt terms on demand if the term you require for abstraction does not exist in the CTRP database. Once imported, CTRP syncs the term with in the NCIt database automatically.

If a term does not exist (i.e., has not been published yet) in the NCIt, you can request the term directly from EVS. Once EVS curators have responded to your request, you can enter new term details when abstracting trials. Later EVS publishes the new term in the NCIt. Refer to Managing Disease and Intervention Terminologies.

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1. At the bottom of the Interventions page, click Manage NCIt Terms.
   The Manage NCIt Terms menu contains options for managing intervention terms.
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2. Follow the instructions in the following sections:

• Importing Intervention Terms

• Synchronizing Intervention Terms

• Requesting New Intervention Terms

• Entering Intervention Terms

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Abstracting Arms 

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When adding arms to a trial, you assign to them the interventions currently abstracted for the trial.

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• There must be at least one arm/group that implies that the entire study subject population receives the same intervention.

• The number of arms/groups added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Interventional Trial Design Details.

• Every arm must have at least one assigned intervention (except for the arm type "no intervention").
• Every intervention must be assigned to at least one arm.
• There must be only one arm with the same combination of description and associated intervention.
• Arm details for single-arm trials are not required.

Trials can have multiple arm records. Each record displays the following arm information:

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Field

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Definition

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Label

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Short name used to identify the arm or comparison group.

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Type

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Description

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Brief description of the arm or comparison group to distinguish it from other arms/groups in the trial.

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Assigned Interventions

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Adding Arms

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You can add one or more arms to a trial according to the trial’s design details.

How to Add Arms

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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.

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Trial Description

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Instruction

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Label*

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Type the descriptive name of the arm.

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Type*

Select the appropriate arm function. Valid values are as follows: 

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Arm Description

Type a brief description of the arm.

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Assignment

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For arm types other than No Intervention, select the check box in the column for the intervention assigned to the current arm.

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Editing Arms

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You can edit arm records as necessary.

How to Edit Arm Records

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Deleting Arms

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When you delete arms from a trial, you delete them from the system, and can not recover them.

How to Delete Arms

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Arms. The Arms page appears.

3. In the Delete column for the appropriate record, click the Delete icon.

   Warning
   There is no way to recover a deleted record. If you delete a record accidentally, follow the instructions in Adding Arms to add it back.

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Abstracting Groups and Cohorts

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Group/cohort information pertains to Complete non-interventional trials only. In non-interventional studies, cohorts are groups of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who are examined or traced over a given time period.

When adding groups to a trial, you assign to them the interventions currently abstracted for the trial.

The following rules apply to each trial:

• There must be at least one group/cohort that implies that the entire study subject population receives the same intervention.

• The number of groups/cohorts added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Non-Interventional Trial Design Details .

• Every group/cohort must have at least one assigned intervention.
• Every intervention must be assigned to at least one group/cohort.
• A trial must have only one group with the same combination of description and associated intervention.

Trials can have multiple group/cohort records. Each record displays the following group information:

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Adding Groups

You can add one or more groups to a trial according to the number specified in the trial’s design details. See Abstracting Non-Interventional Trial Design Details .

How to Add Groups

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Editing Groups

You can edit group records as necessary.

How to Edit Group Records

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Deleting Groups

When you delete groups from a trial, you delete them from the system, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Groups to add it back.

How to Delete Groups

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
3. In the Delete column, select the check box for the appropriate record(s), and then click Delete.
4. To delete all groups, click Select All, and then click Delete.

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Abstracting Sub-Groups

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Trials can have multiple sub-group records. Each record displays the following information about the disease or conditions:

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Adding Subgroups

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You can add one or more sub-groups to a trial according to the trial’s design details.

How to Add Sub-groups

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Editing Subgroups

You can edit sub-group records as necessary.

How to Edit Sub-group Records

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Sub-groups. The Sub-groups page appears.
3. In the Edit column for a given record, click the Edit icon. The Add/Edit Sub-group Information page appears.
4. Modify the sub-group details according to instructions in Adding Sub-Groups.
5. Click Save.

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Deleting Subgroups

When you delete groups from a trial, you delete them from the system, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Sub-Groups to add it back.

How to Delete Sub-groups

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
2. On the Scientific Data menu, click Sub-groups. The Sub-group page appears.
3. In the Delete column for the appropriate record, click the Delete icon.

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