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Form status details

A CRF (Case Report Form) is a standardized document used to collect and record data from each subject enrolled in the study. The CRF typically includes various fields for collecting information about the patient's medical history, demographics, laboratory results, adverse events, and other study-related information.

Within the Form Status Details page, you can view the details on each CRF pulled from the EDC system. These details include information about the most current status of each form. Each CRF status and other form characteristics are explained in detail in the following table.

Viewing form status details
Figure 1. Viewing form status details

Column

Details

Site Code

Represents a code of the site where the data for a corresponding CRF 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.

Form Name

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

Complete Status

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

Open Manual Query

Indicates whether a query has been manually opened by users for a CRF because of some pertaining issues.

Answer Manual Query

Indicates whether some users have responded to the opened manual queries related to a corresponding CRF.

Open System Query

Indicates whether a query has been automatically generated by the system for a CRF because of some pertaining issues.

Answer System Query

Indicates whether some users have responded to the opened system-generated queries related to a corresponding CRF.

SDV

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

DM Review

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

CRA Review

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

Safety Review

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

Softlock

Indicates whether the data collected for a corresponding CRF is temporarily locked or restricted from further editing because some issues require further investigation or resolution.

Sign

Indicates whether the data collected for a corresponding CRF has been signed by the investigator or the sponsor, indicating that they have reviewed and approved the entered data.
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 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).

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 involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.