Upload New Data Version

Upload a new data version for the selected study. Specify whether the data is raw, SDTM, or ADAM.

Download table

Site(s)

Dosages

Tumor type

Disposition Event Subcategory

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Treatment

Tumor Type

Arm/Treatment

Subject/Patient

Tumor type

Relation to Treatment

CTCAE Grade

Dosing table

Concomitant medication

Concomitant medication of interest

serious adverse events

adverse events requiring hospitalization

adverse events resulting in death

clinically significant lab events

treatment-emergent adverse events

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Arm/Treatment

Assessment

Tumor type

Evaluator

Evaluator ID

Only show first PD

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Dosing table

Concomitant medication

Arm/Treatment

Subject/Patient

Tumor type

Grouping variable

Multiple plots per lab test

Faceting variable (e.g. ARM, SITE)

X-axis:

Study Day Collection Date

Study day range

Result Value Range

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Subject/Patient

Serious Events?

AEs leading to Death:

Tumor:

Age:

Sex:

Race:

Ethnicity:

Country:

Cohort:

Informed Consent Date:

Study Completion Date:

NHL SubType:

Arm:

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SDTM

Select SDTM Dataset:

Select output type:

Generate specification (Be sure to upload study documents like the CRF, SOE, and Protocol)

Derive SDTM from spec (Be sure to upload the spec and any code lists and coding reports)

Dataset Projects

RAW

Other study-related files

Manage files

Files to include in derivation

SDTM Derivation Workflow

Review Generated SDTM Dataset and Specification

Please review the generated dataset and the specification (spec) that was used to generate it. You can edit the spec below. After editing, submit to update only the relevant code.

Generated SDTM Dataset

Specification Used (Editable)

Column Feedback

Select columns that are incorrect:

Describe what's wrong with the selected columns:

Dataset Summary

Selected Columns Info

Generated Specification

Saved Spec Versions

Download Selected

Backups

Save and restore previous versions of your spec and generated code:

Execute Generated Code

Run the generated R code and save results to output directory:

Available Result Files

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Uploaded Data Filesets

None

Actions

Available Downloads

Please choose an objective:

Browse through your files and download files

Produce a scatter plot, line plot, boxplot, or histogram. Choose grouping, color, and faceting variables. Filter by a variable value such as lab test.

Choose lab and exposure datasets, or any two datasets with a common variable to merge on and date variables corresponding to the beginning of study and date of interest. The app will calculate the study day from these two variables. For example, can use lb and ex, or lb and rand, lb and dm, etc. Save the merged dataset for later use, then use it to plot

Choose the data source for Data explorer. The default data source is files on the server. Your selection here does not affect access to study dashboards.

Previously accessed folders

Folders shared with you

Keep/drop rows where...

...is equal to

Download file

Action

Grant Revoke

Users

Studies

Double click on field in table to edit. Hit Ctrl + Enter to save, Esc to cancel editing

Company

Company Code

Double click on field in table to edit. Hit Ctrl + Enter to save, Esc to cancel editing

Study Code

Company

Study Description

Concomitant Medication

SubjID is unique?

Action

Enable Disable

Dashboard

Study

Admin Panel Access

Enable Disable

User

Role

Create a New User

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Username

Password

Confirm Password

Upload New Data Version

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Dosing table

Concomitant medication dose

AE concomitant meditation table

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Category

Assessment

Tumor type

Evaluator

Evaluator ID

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Dosing table

Concomitant medication dose

Tumor type

Grouping variable

Faceting variable (e.g. ARM, SITE)

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SDTM

Dataset Projects

RAW

Other study-related files

Manage files

Files to include in derivation

SDTM Derivation Workflow

Review Generated SDTM Dataset and Specification

Generated SDTM Dataset

Specification Used (Editable)

Column Feedback

Dataset Summary

Selected Columns Info

Generated Specification

Saved Spec Versions

Backups

Execute Generated Code

Available Result Files

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Actions

Available Downloads

Please choose an objective:

Choose the data source for Data explorer. The default data source is files on the server. Your selection here does not affect access to study dashboards.

Exposure dataset

Subject ID variable for exposure dataset

Exposure date variable

Exposure date format

Lab dataset

Subject ID variable for lab dataset

Lab date variable

Lab date format

Plot options

Faceting variable (e.g. TRT, SUBJID)

Plot options

X-axis variable

X-axis label

Y-axis variable

Y-axis label

Gate X variable

Gate Y variable

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