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Query management

While working with forms in EDC and finding some inaccurate or missing data, you can create queries for responsible users to address the issues and either correct them or confirm the data's accuracy. A query is a request to fix the encountered discrepancy in the study data.

There are two types of queries in the EDC system:

  • System: automatically created by the system when the data is missing or does not match the expected criteria.

  • Manual: manually created by users when the data is missing, questionable, or does not match the expected criteria.

Important

Users can create only manual queries, although users must address both manual and system ones to resolve them.

Typically, in the EDC system, queries are created by the data manager (DM) or clinical research associate (CRA) during data review and addressed by the clinical research coordinator (CRC) working at sites and having access to original data for check-ups.

For instance, when CRA compares CRF data with the source document and encounters a discrepancy, they open a query asking CRC to fix it. For example, the birth date in a CRF is 1999, but in a source document, it is 1998. Then, the CRC must go to the CRF in EDC and fix the date to comply with the source.

Another example can be from the DM's perspective. If a DM encounters a birth date of the year 2203, which is obviously in the future and cannot be true, they open a query for a CRC to check the data in the source document and fix it in the CRF.

If you are responsible for query resolution and management in EDC, you can access all the queries that require your attention from the My Queries section of the My Work dashboard.

Here is what else is possible in terms of query management in EDC:

In this section:

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 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.

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