Summary
This article covers the default fields available in the configurable data management form.
Table of Contents
The Data Management plan for the study is managed through the Data Management form, one of many Configurable Forms. It is from this screen that relevant information concerning the Data Managers, eCRF and Data Management Plan can be collected. Each Study contains the Data Management form (labeled Edit Data Management). What is displayed on this form can be configured from CTMS Settings.
Access Data Management Form
The Data Management form for existing studies can be accessed by clicking Data Management under the Clinical Plans sub-menu for the study.
Default Fields
The Data Management form contains the following fields by default:
Data Manager(s) Field
The Data Manager(s) field is a Personnel Select field used to identify the Data Manager personnel who will be working on the study. By default, the Data Manager(s) field is a preferred field and a red alert will fire if the Data Manager(s) data is not provided.
Effective Date Field
The Effective Date field is a date field, and is used to identify the effective date of the Data Management Plan. By default, the Effective Date field is a preferred field and a red alert will fire if the Effective Date data is not provided.
Version Field
The Version field is an integer field used to identify the version of the Data Management Plan. A whole number must be entered into the field or an alert will fire. By default, the Version field is a preferred field and a red alert will fire if the version is not provided.
EDC System Field
The EDC System field is Vendor Select field used to identify the EDC vendor who will be working on the study. When the Vendor Select dialog opens the Vendor Services will be filtered on EDC Provider. By default, the EDC System field is a preferred field and a red alert will fire if the EDC System data is not provided.
Actual Number of eCRF Field
The Actual Number of eCRF field is an integer field used to identify the total number of eCRF planned for the study casebook. A whole number must be entered into the field or an alert will fire. By default, the Actual Number of eCRF field is a preferred field and a red alert will fire if the Actual Number of eCRF data is not provided.
Actual Number of Unique eCRF Field
The Actual Number of Unique eCRF field is an integer field used to identify the total number of unique eCRF planned for the study casebook. A whole number has to be entered into the field or an alert will fire. By default, the Actual Number of Unique eCRF field is a preferred field and a red alert will fire if the Actual Number of Unique eCRF data is not provided.
Number of Edit Checks Field
The Number of Edit Checks field is an integer field used to identify the total number of edit checks planned for the study casebook. A whole number has to be entered into the field or an alert will fire. By default, the Number of Edit Checks field is a preferred field and a red alert will fire if the Number of Edit Checks data is not provided.
Plans Field
The Plans field is a Multi Document field used to upload the Data Management Plan and any other Data Management Plan supporting documents. By default, the Plans field is a preferred field and a red alert will fire if the plans are not provided.
Save Actions
Save Button
When the Save button is selected the data entered for the questions will be saved and the user will be directed to the Edit Study form.
Cancel Button
When the Cancel button is selected the data entered for the questions will not be saved and the user will be directed to the Edit Study form.
Importing Data Management Details
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This information can be imported as part of the Study import. Click here for more information.
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