Data Management: Queries in Clinical Trials

When an item or variable has an error or a query raised against it, it is said to have a “discrepancy” or “query”.

All EDC systems have a discrepancy management tool or also refer to “edit check” or “validation check” that is programmed using any known programming language (i.e. PL/SQL, C# sharp, SQL, Python, etc).

So what is a ‘query’? A query is an error generated when a validation check detects a problem with the data. Validation checks are run automatically whenever a page is saved “submitted” and can identify problems with a single variable, between two or more variables on the same eCRF page, or between variables on different pages. A variable can have multiple validation checks associated with it.

Errors can be resolved in several ways:

  • by correcting the error – entering a new value for example or when the datapoint is updated
  • by marking the variable as correct – some EDC systems required additional response or you can raise a further query if you are not satisfied with the response

Dealing with queries
Queries can be issued and/or answered by a number of people involved in the trial. Some of the common setups are: CDM, CRA or monitors, Site or coordinators.

Types of Queries

  • Auto-Queries or Systems checks
  • Manual Queries
  • Coding Queries
  • SDV related Queries generated during a Monitor visit
  • External Queries – for external loaded data in SAS format

EDC Systems and Discrepancy Output Examples

InForm

Note: All queries are associated to a single data item relevant to that query.

RAVE

Note: Users are only able to see / perform an action on a query based on their
role and the permissions via Core Config.

Timaeus

Note: Queries are highlighted by a red outline and a Warning icon.

OpenClinica

Note: Extensive interfaces for data query.

Query Metrics – It is important to measure the performance of your clinical trials.
Metrics are the same for all clinical studies but not all EDC systems are the same. Standardized metrics encourage performance improvement, effectiveness, and efficiency. Some common metrics are:

  • Outstanding Query
  • Query Answer Time
  • Average Time to Query Resolution
  • Number of closed discrepancies on all ongoing studies

Data management’s experience with data queries in clinical trials

FAIR USE
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Trademarks: InForm is a trademark or registered trademark of Oracle Corporation. Rave is a trademark or registered trademark of Medidata. Timaeus is a trademark or registered trademark of Cmed Clinical Research.


Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.

Advertisements