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Query report

In eClinical, a query can be opened to ask a question or get feedback from a designated system user on a particular data item in a CRF, trip report, protocol deviation record, or ICF tracking log record. There are two types of queries in the system:

  • Manual queries: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System queries: these are generated automatically by the system and require user interaction to manage and resolve them.

In CTMS, the Query Report feature is a comprehensive summary used by data managers (DM) and clinical research coordinators (CRC) to follow query status data collected from various sources in CTMS and pulled from EDC.

The following reports can be used to analyze the query data:

  • Query Aging Summary: the charts are built based on EDC data and used to track the query processing status at site and study levels. The report shows how many days the query status is open and closed.

  • Manual Query Details: the report is built based on EDC data and helps to explore the manually created queries per visit, CRF, record, or item and their details, such as level, status, topic, overdue state, replies, users addressing them, and so on.

  • System Query Details: the report is built based on EDC data and displays all the queries per each CRF item automatically created by the system and their details, such as query status, topic, overdue, replies, users addressing them, and more.

  • All Query Report: the report is built based on EDC data and displays the manually and system-created queries, such as query level, status, topic, overdue, replies, users addressing them, and others.

  • PD Queries: the report comprises all queries opened for protocol deviation records in CTMS and their details, such as query status, topic, replies, users addressing them, and more.

  • Trip Report Queries: the report comprises all queries opened for completed trip reports in CTMS and their details, such as query status, topic, replies, users addressing them, and more.

  • ICF Tracking Log Queries: the report comprises all queries opened for ICF tracking log records in CTMS and their details, such as query status, topic, replies, users addressing them, and more.

  • Action Item Queries: the report compiles and displays all the queries opened on action item data to raise questions, request clarification, or highlight concerns related to the information entered.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A document that summarizes the activities, observations, and findings of a monitoring visit conducted by a clinical research associate (CRA) or a monitor at a clinical trial site. The purpose of a trip report is to provide a detailed account of the visit, including the review of study data, source documents, regulatory compliance, and overall study conduct.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

A document used to track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial. It is a management tool that ensures proper documentation and completion of all steps related to informed consent throughout the trial process.

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 the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

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.

In CTMS, an instance created to address issues or discrepancies discovered during a monitoring visit. One issue may have several action items associated with it because a resolution of a single issue may require several steps.