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Data reconciliation is the process of correcting, clarifying, or verifying data reported on the Case Report Forms. Query letters identify the data that needs to be corrected, clarified, or verified. Queries are generated by either the sponsoring Cooperative Group or the CTSU. All queries are sent from the CTSU to the site. The queries are then tracked in the Oracle Clinical Database and reports on response times, as well as query category information, are available on all sites. These reports were developed as part of the Site Quality Assurance plan to inform the sites of what their outstanding data is as well as query volume and response times. Sites participating through the CTSU via the Cooperative Group mechanism are expected to adhere to their affiliated Groups' standards for quality control. The sites are also responsible for complying with any additional or differing policies outlined in an endorsed or cross-group protocol accessed via the CTSU menu.
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There are four reports that are distributed to each site on a quarterly basis with reports being sent to sites using a rolling distribution method.
- Canadian sites and U.S. (States) sites beginning with letters A-I will be distributed in January, April, July, and October.
- U.S. (States) sites beginning with letters K-N will be distributed in February, May, August and November.
- U.S. (States) sites beginning with letters O-W will be distributed in March, June, September and December.
The three reports are: (1) Site Summary Report, (2) Site Summary Detail Report, and (3) Query Category Report. Site Summary Reports will be distributed to each site. The following information is included in this report:
- Total patient enrollment including accruals per protocol and Principal Investigator.
- Comparison of average days to respond for each institution to all other CTSU participating institutions.
- For a specific institution, comparison of the average number of data queries per CRF to the overall CTSU average.
- Delinquency information is provided by protocol and Principal Investigator in addition to the query information.
- CRF
and query sheet data per protocol to include:
- Total CRFs received per patient/per protocol
- Total number of queries
- Total number of responses received
- Total number of outstanding responses
- Average days to response per protocol
- Oldest pending query per protocol
Site Summary Detail reports will also be distributed to each site. This report gives more detailed information on each specific query. The following information is included in this report:
- Patient ID
- CRF short name
- Query category
- Query reference code
- Date sent to site and date received
- Response and pending times in days
Query Category Reports will be distributed to each site along with the other two reports. This report gives information on what types of queries are being generated. Descriptions of each of the categories are outlined on the second page of the report. The information detailed in this report includes:
- Inconsistent or missing data
- Key Information
- Adverse Events/Serious Adverse Events
- Data verification
- Wrong form
- Additional source documentation
- Missing report
- Missing Case Report Form
- Total queries
- Query/CRF
- These reports will contain no weighted indicators for site performance, although these are currently under consideration by the CTSU Quality Assurance Committee.
- Site Summary Reports will be flagged each month by the CTSU Quality Assurance manager when a site's pending query response rate is greater than 60 days. The CTSU QA Manager will be contacting those sites on a quarterly basis by email to assist the site in resolving any pending queries.
- The CTSU Quality Assurance Committee will conduct a review of all CTSU Independent Clinical Research Sites (CICRS).