Managing Data and Query Expectation in NCI Research Studies

December 11 2023

In order to provide continuing study key timepoints to clinical trial sponsors, participant data should be entered within protocol standards. It is essential that the generated queries complete the communication for accurate reporting.

Data quality and query performance feedback are provided via institutional performance evaluations in data collection, data management, and overall data quality.

Member institutions and affiliate sites are required to manage the completion of data timeliness and query resolution.

Oversite of a multi-facility network in regard to data quality encompasses activities which include compliance in:

  • Specimen submission
  • Patient reported outcomes/Quality of Life questionnaires
  • Adverse event and serious adverse event reporting
  • Overall data management and queries
  • Patient enrollment with appropriate stratification factors

Site management of data entry is very important with many sites utilizing the data management tools in Cancer Trials Support Unit (CTSU) Data Quality Portal. Legacy data requirements can also be present in each of the specific research group website coordinator portals. Site data coordinators should also review those sites to obtain the most complete data and query requirements.

Discussions with facilities that are managing affiliates have expressed the requirement for the main member to routinely provide timeliness reports to their sub-affiliates. Reports should be provided to those sites to help resolution by entry of the information in the data capture system or correspondence with the protocol specific data manager. Constant and ongoing communication between the main member and affiliated sites is key to appropriate reporting and completion of study data expectations including data endpoints. Data reports should be provided from both the CTSU data quality portal management system and each of the research base site coordinator portals and research base performance reports.

Understanding that the resolution of queries and completion of data is necessary to meet study timelines to provide the best possible treatment for patients in the future.

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