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CRF completion status

Within the CRF Completion Status page, you can view the most actual statistics pulled from the EDC system on the count of CRFs filled out for a specific study. The statistics also include information about the status of each CRF and other data pertinent to the form completion and review. On the CRF Completion Status page, the statistical data on the CRF completion can be viewed in three tabs as explained in the following sections.

CRF completion status report

CRF Completion Status Report. Under this tab, you can view general statistics about the completion status of CRFs for the selected study. All the statistical data pertinent to this report is explained in detail in the following table.

Viewing CRF completion status report tab
Figure 1. Viewing CRF completion status report tab

Column

Details

Site Code

Represents a code of the site where the data for corresponding CRFs has been collected.

Subject ID

Represents an ID of a subject for whom the data has been collected on a corresponding CRF.

Visit Name

Represents the name of the visit during which the data has been collected for a corresponding CRF.

Date of Visit

Represents the date when a corresponding visit has occurred.

Status

Represents the current status of the CRF depending on its completeness.

Form Name

Represents the name of the CRF that is used for data collection purposes.

Open Manual Queries

Indicates whether any queries have been manually opened by users for a CRF because of some pertaining issues.

Open System Queries

Indicates whether any queries have been automatically generated by the system for a CRF because of some pertaining issues.

DM Review

Indicates whether anyone from the data management team has already reviewed the data collected for a corresponding CRF.

CRA Review

Indicates whether the clinical research associates have already reviewed the data collected for a corresponding CRF and whether any queries or issues have been raised and documented for resolution.

Safety Review

Indicates whether the adverse events data collected in a corresponding CRF has been reviewed by the safety team and whether any safety issues have been addressed and documented.

SDV

Indicates whether the clinical monitor or a quality control team member has reviewed the data collected for a corresponding CRF and whether it complies with source documents.

Report summary by subject

Report Summary by Subject. Under this tab, you can view statistics about the completion status of CRFs grouped by each study subject. All the statistical data pertinent to this report is explained in detail in the following table.

Viewing report summary by subject
Figure 2. Viewing report summary by subject

Column

Details

Site Code

Represents a code of the site where the data for corresponding CRFs has been collected.

Subject ID

Represents an ID of a subject for whom the data has been collected on a corresponding CRF.

Total Expected Forms

Represents the total number of CRFs expected to be filled out for a corresponding subject.

Complete Count

Represents the total number of CRFs that have already been filled out for a corresponding subject.

Complete Percentage

Represents the percentage of CRFs that have already been filled out for a corresponding subject. The percentage is calculated from the total count of CRFs.

Incomplete Count

Represents the total number of CRFs that have not been filled out for a corresponding subject.

Incomplete Percentage

Represents the percentage of CRFs that have not been filled out for a corresponding subject. The percentage is calculated from the total count of CRFs.

Missing Count

Represents the total number of CRFs that still need to be filled out for a corresponding subject.

Missing Percentage

Represents the percentage of CRFs that still need to be filled out for a corresponding subject. The percentage is calculated from the total count of CRFs.

Open Queries Count

Represents the total number of queries that have been opened on all CRFs for a corresponding subject.

Open Queries Percentage

Represents the percentage of queries that have been opened on all CRFs for a corresponding subject. The percentage is calculated from the total count of CRFs.

SDV Count

Represents the total number of CRFs reviewed by a clinical monitor or a quality control team member to verify that the form data complies with source documents.

SDV Percentage

Represents the percentage of CRFs reviewed by a clinical monitor or a quality control team member to verify that the form data complies with source documents. The percentage is calculated from the total count of CRFs for a corresponding subject.

DM Review Count

Represents the total number of CRFs reviewed by anyone from the data management team.

DM Review Percentage

Represents the percentage of CRFs reviewed by anyone from the data management team. The percentage is calculated from the total count of CRFs for a corresponding subject.

CRA Review Count

Represents the total number of CRFs reviewed by clinical research associates to verify the data collected for CRFs and check whether any queries or issues have been raised and documented for resolution.

CRA Review Percentage

Represents the percentage of CRFs reviewed by clinical research associates to verify the data collected for CRF forms and check whether any queries or issues have been raised and documented for resolution. The percentage is calculated from the total count of CRFs for a corresponding subject.

Safety Review Count

Represents the total number of CRFs reviewed by the safety team to verify the adverse events data collected on CRFs and check whether any safety issues have been addressed and documented.

Safety Review Percentage

Represents the percentage of CRFs reviewed by the safety team to verify the adverse events data collected on CRFs and check whether any safety issues have been addressed and documented. The percentage is calculated from the total count of CRFs for a corresponding subject.

Report summary by site

Report Summary by Site. Under this tab, you can view statistics about the completion status of CRFs grouped by each study site. All the statistical data pertinent to this report is explained in detail in the following table.

Viewing report summary by site
Figure 3. Viewing report summary by site

Column

Details

Site Code

Represents a code of the site where the data for corresponding CRFs has been collected.

Total Expected Forms

Represents the total number of CRFs expected to be filled out at a corresponding site.

Complete Count

Represents the total number of CRFs that have already been filled out at a corresponding site.

Complete Percentage

Represents the percentage of CRFs that have already been filled out at a corresponding site. The percentage is calculated from the total count of CRFs.

Incomplete Count

Represents the total number of CRFs that have not been filled out at a corresponding site.

Incomplete Percentage

Represents the percentage of CRFs that have not been filled out at a corresponding site. The percentage is calculated from the total count of CRF forms.

Missing Count

Represents the total number of CRFs that still need to be filled out at a corresponding site.

Missing Percentage

Represents the percentage of CRFs that still need to be filled out at a corresponding site. The percentage is calculated from the total count of CRFs.

Open Queries Count

Represents the total number of queries that have been opened on all CRFs at a corresponding site.

Open Queries Percentage

Represents the percentage of queries that have been opened on all CRFs at a corresponding site. The percentage is calculated from the total count of CRFs.

SDV Count

Represents the total number of CRFs reviewed by a clinical monitor or a quality control team member to verify that the form data complies with source documents.

SDV Percentage

Represents the percentage of CRFs reviewed by a clinical monitor or a quality control team member to verify that the form data complies with source documents. The percentage is calculated from the total count of CRFs for a corresponding site.

DM Review Count

Represents the total number of CRFs reviewed by anyone from the data management team.

DM Review Percentage

Represents the percentage of CRFs reviewed by anyone from the data management team. The percentage is calculated from the total count of CRFs for a corresponding site.

CRA Review Count

Represents the total number of CRFs reviewed by clinical research associates to verify the data collected for CRFs and check whether any queries or issues have been raised and documented for resolution.

CRA Review Percentage

Represents the percentage of CRFs reviewed by clinical research associates to verify the data collected for CRFs and check whether any queries or issues have been raised and documented for resolution. The percentage is calculated from the total count of CRFs for a corresponding site.

Safety Review Count

Represents the total number of CRFs reviewed by the safety team to verify the adverse events data collected on CRFs and check whether any safety issues have been addressed and documented.

Safety Review Percentage

Represents the percentage of CRFs reviewed by the safety team to verify the adverse events data collected on CRFs and check whether any safety issues have been addressed and documented. The percentage is calculated from the total count of CRFs for a corresponding site.
In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).