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 OBJECTIVE 2: DATA SUBMISSION

As each protocol has specific time requirements for data submission, it is important to identify these benchmarks and create a data submission calendar individualized for each patient. Data should be submitted to the CTSU according to the data submission schedules outlined in the protocol. All forms and documents associated with the study can be downloaded from the Protocol page on the CTSU Registered Member Web Site.

Section topics include:
Submission of Data Forms
Remote Data Capture
Request for Resubmission of Data
Shipping of Specimens and Radiology Films
Data Reconciliation
Query Letters/Data Clarification Forms
Site Initiated Data Corrections
Delinquent Case Report Forms

Module Objectives
1
 Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2
 Describe the procedure for submission of data to the CTSU
3
 Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4
 Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5
 Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention
6
 Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7
 Explain CTSU Quality Assurance
Submission of Data Forms

All Case Report Forms for patients registered through the CTSU are submitted to CTSU Data Operations and must be accompanied by a completed CTSU Data Transmittal Form. All original forms are submitted in accordance with the protocol and study leadership guidelines. NOTE: Mail all CRFs to the CTSU. Do not fax CRFs. A copy of the original CRFs should be maintained in the patient's CRF Notebook.

Upon receipt of data, the CTSU data operations center reviews the data submission packets for accuracy, makes a copy for the CTSU files, and forwards the original data on to the sponsoring Cooperative Group (unless otherwise agreed upon between the CTSU and the sponsoring Cooperative Group). The data is then logged in as received at CTSU, keyed into the database, scanned and filed. Any problematic data (e.g., missing patient ID#, missing protocol ID#, etc.) is returned to the site for corrective action using a Request for Data Resubmission form.

Alternatively, sites using Remote Data Capture (RDC) will submit their CRF data to the CTSU electronically following the protocol specific RDC guidelines.

Remote Data Capture (RDC)
The Cancer Trials Support Unit, in conjunction with the North Central Cancer Treatment Group, has initiated a pilot project to test the feasibility and advantages of centralized data collection within the Cooperative Group environment. This project utilizes Remote Data Capture (RDC), which permits sites to enter patient-level data into an Oracle Clinical database over the Internet. RDC is also allows for data correction at the point of data entry, and is used to communicate with the sites on discrepant data.

Requests for Resubmission of Data
The CTSU returns to the site any data submission packets that cannot be processed (incomplete/missing data on CRFs, improperly completed CTSU Data Transmittal Forms, etc.). Sites must make the required corrections and resubmit the packet within 5 working days of receipt.
Shipping of Specimens and Radiology Films

Some protocols require the collection of specimens such as tumor blocks or tissue slides and copies of X-ray films. Transmittals and reports associated with pathology, blood, and serum submission must be sent to the address specified in the protocol. These materials are not sent to the CTSU. A copy of all transmittals and reports, accompanied by an accurately completed CTSU Data Transmittal Form, must be submitted to the CTSU as outlined in the protocol. Patient names must be removed to comply with Good Clinical Practice standards, and the Patient ID# and Protocol ID# must be noted on all pages of the reports. Consult the protocol for specific information on shipping of specimens and/or radiology films.
Data Reconciliation

Data reconciliation is the process of correcting, clarifying, or verifying data reported on the CRFs. Query letters identify the data that needs to be corrected, clarified, or verified. All queries are sent from the CTSU to the site, but may be generated by either the CTSU or the sponsoring Cooperative Group. The frequency of discrepant data and timeliness of site response will be used in monitoring site performance.

Before forwarding a data query to a participating site, the CTSU copies and logs queries into a query tracking database at the CTSU for tracking purposes. The study site does the following:

  • Receives and evaluates the query request and takes appropriate action.
  • Responds within 14 working days following receipt of the data query.
  • Submits the response to the CTSU, which includes the original query, amended CRF(s), and/or submission of additional Case Report Forms and accompanying CTSU Data Transmittal Form.
  • Retains a copy of the original query, amended CRF(s), and/or additional CRFs in the patient's CRF Notebook. The returned query, along with all supporting documentation, is logged into the CTSU Query Database and linked to the original query.

The query response is forwarded by CTSU to the sponsoring Group.

Reports are generated by the CTSU to monitor query volume and response time for each CTSU site.

 
Query Letters/Data Clarification Forms

Queries are generated for discrepant or missing data and may be issued either by the Cooperative Group (query letter) or by the CTSU (data clarification form or DCF). In either case, the queries and DCFs are tracked in the CTSU query tracking database and forwarded to the site with a request for corrective action.

Each Cooperative Group Data Center generates data queries in accordance with the standards for the Group. For Cooperative Group-generated queries, the sponsoring Group determines the schedule, content, and format. When the CTSU receives queries from the Group, the CTSU logs them into the CTSU query tracking database and forwards them to participating sites. For RDC entered data, the Cooperative Group will log the query into the RDC screens.

For protocols where CTSU is identifying discrepant data, the discrepancy is noted on a DCF and forwarded to the site. Alternatively, if the site is participating in Remote Data Capture, it is notified of the discrepancy electronically via the RDC application. Sites participating in RDC are expected to review for and resolve discrepancies on a daily basis.

Upon receipt of the query, the site should follow the specified instructions for amending the identified data point and submitting the data to the CTSU.

Corrections to CRFs are made with a single line through the error, initialed and dated by the person amending the form. The site retains a copy of the amended CRF. Or, if the correction is noted directly on the query letter or DCF, a copy of that form should be retained by the site. All documentation must be kept in the CRF Notebook.

As a response to every data query, the site should include each of the following in the data submission:

  • A copy of amended Case Report Form (if applicable);
  • A copy of the requested clinical report (if applicable);
  • A copy of the query letter (or DCF) with, if applicable, requested notations;
  • A copy of the CTSU Data Query Transmittal memo;and
  • A CTSU Data Transmittal Form indicating that the data submission is in response to a query.
Site-Initiated Data Corrections
Sites may initiate a data correction as part of an internal quality assurance procedure.
All amended data are initialed and dated.
A copy of the amended CRF should be made and kept in the patient's CRF Notebook.
Amended CRFs are forwarded to the CTSU Data Operations Center, accompanied by a CTSU Data Transmittal Form.
It must be indicated on the transmittal form that the data are amended.
Delinquent Case Report Forms
Each sponsoring Group generates reports for delinquent CRFs and clinical reports. For protocols where CTSU is identifying delinquent CRFs and clinical reports, the CTSU will generate and send delinquency notification reports to the site. The delinquent CRF and clinical report data along with the timeliness of site response will be used in monitoring site performance.
The Group sends these delinquency notification reports to the CTSU Data Operations Center.
The CTSU Data Operations Center reviews the delinquency notification report, enters the pertinent information into a delinquency database, and forwards the delinquency report to the site.
The site should resolve the issue by sending the delinquent CRF or clinical report, accompanied by the delinquency notification report and a completed CTSU Data Transmittal Form, to the CTSU Data Operations Center within 7 working days following receipt of the delinquency report. The CTSU Data Transmittal Form should indicate that the data submission is in response to a delinquency notification report.
The CTSU Data Operations Center makes a copy of and records receipt of the delinquent items both the delinquency database and the study database.
The delinquent CRF or clinical report is then forwarded to the sponsoring Group.

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