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This page tree describes how to abstract and edit the scientific details of clinical trials.
About Scientific Data
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Abstracting Trial Descriptions
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Abstracting Interventional Trial Design
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Abstracting Non-Interventional Trial Design
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Abstracting Outcomes
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Abstracting Eligibility Criteria
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Abstracting Diseases and Conditions
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Abstracting Data Table 4 Anatomic Sites
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Abstracting Biomarkers
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Abstracting Interventions
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Abstracting Arms
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| MultiExcerptName | abstractarms |
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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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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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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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Intervention(s) assigned to a given arm.
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Interventions imported from ClinicalTrials.gov may not match CTRP terminology. |
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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
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, click Arms. The Arms page appears.
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.
Abstracting Groups and Cohorts
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| MultiExcerptName | abstractcohort |
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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.
| Info | ||
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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:
| Field | Definition |
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Label | Short name used to identify the group |
Description | Explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure). |
Assigned Interventions | Intervention assigned to a given group |
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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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Field | Instruction/Description |
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Label* | Enter the descriptive name of the group. |
Description* | Enter a brief description of the group. |
Assignment | Select the check box(s) in the column for the intervention(s) assigned to the current group. |
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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
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
- In the Delete column, select the check box for the appropriate record(s), and then click Delete.
- To delete all groups, click Select All, and then click Delete.
Abstracting Sub-Groups
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| MultiExcerptName | abstractsubgroups |
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Trials can have multiple sub-group records. Each record displays the following information about the disease or conditions:
Field | Definition |
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Code | Characters, or phrase used to identify the sub-group |
Description | Stratification criteria |
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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data. |
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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
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, click Sub-groups. The Sub-groups page appears.
- In the Edit column for a given record, click the Edit icon. The Add/Edit Sub-group Information page appears.
- Modify the sub-group details according to instructions in Adding Sub-Groups.
- Click Save.
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
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- On the Scientific Data menu, click Sub-groups. The Sub-group page appears.
- In the Delete column for the appropriate record, click the Delete icon.
