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46A A survey of data entry methods: Substituting data for “religion”
Abstracts
59S
coordinates monthly committee reviews. Events which do not meet confirmed criteria are reviewed by the CECo Each event is reviewed independently by two physicians blinded to protocol and study treatment. Events are classified for diagnostic certainty and additional information may be requested. Disagreements are adjudicated by the original two reviewers. 1,902 events have been processed to date. 935 (49 %) did not clearly meet confirmed criteria and were reviewed by the CEC. 262 (14%) of the events were either upgraded or downgraded from the level of certainty reported by the site clinician. This CE system standardizes the classification of events across sites and trials. The blinded and timely review of events, done on an ongoing basis throughout a trial, ensures that quality endpoint data are available for data and safety monitoring.
46A A SURVEY OF DATA ENTRY METHODS: SUBSTITUTING DATA FOR "RELIGION" Stephen W. Singer* M. Marvin Newhouse and Barbara S. Hawkins
Dedicated Response* Johns Hopkins University Baltimore, Maryland There is a long-standingdisagreement among people responsible for clinical trials data management about the need to key data more than once. In the past 2 years, 3 centers have published their methods and associated error rates. However, the real issues have been obscured by opinion and only limited information is provided by the published case studies. The purposes of our survey are to (1) provide baseline data on the number of coordinating centers using each style of data entry; (2) explore the linkage between the type of data entry chosen and other study or data management design features; and O) clarify any relation between data entry methods and estimates of the overall or "residual" error ratedifferences detected through systematic sampling between the computerized, presumably "clean" study database and the original source documents. Manuals of procedures for 22 randomized clinical trials sponsored by the National Eye Institute since 1978 were surveyed to determine data entry methods-single or double keying. Of this sample, 3 keyed data once, 9 keyed twice, and 10 did not supply this level of detail. A followup mail and telephone survey is being conducted to supplement this information and to obtain data on error rates experienced. Other coordinating centers, identified through the Clinical Trials Resource Center Registry maintained by the Johns Hopkins Center for Clinical Trials, will also be included in the followup survey. Findings from the surveys will be presented, including guidelines distilled from the collective experience of centers using various data entry methods for different study and data management system designs.
59S
coordinates monthly committee reviews. Events which do not meet confirmed criteria are reviewed by the CECo Each event is reviewed independently by two physicians blinded to protocol and study treatment. Events are classified for diagnostic certainty and additional information may be requested. Disagreements are adjudicated by the original two reviewers. 1,902 events have been processed to date. 935 (49 %) did not clearly meet confirmed criteria and were reviewed by the CEC. 262 (14%) of the events were either upgraded or downgraded from the level of certainty reported by the site clinician. This CE system standardizes the classification of events across sites and trials. The blinded and timely review of events, done on an ongoing basis throughout a trial, ensures that quality endpoint data are available for data and safety monitoring.
46A A SURVEY OF DATA ENTRY METHODS: SUBSTITUTING DATA FOR "RELIGION" Stephen W. Singer* M. Marvin Newhouse and Barbara S. Hawkins
Dedicated Response* Johns Hopkins University Baltimore, Maryland There is a long-standingdisagreement among people responsible for clinical trials data management about the need to key data more than once. In the past 2 years, 3 centers have published their methods and associated error rates. However, the real issues have been obscured by opinion and only limited information is provided by the published case studies. The purposes of our survey are to (1) provide baseline data on the number of coordinating centers using each style of data entry; (2) explore the linkage between the type of data entry chosen and other study or data management design features; and O) clarify any relation between data entry methods and estimates of the overall or "residual" error ratedifferences detected through systematic sampling between the computerized, presumably "clean" study database and the original source documents. Manuals of procedures for 22 randomized clinical trials sponsored by the National Eye Institute since 1978 were surveyed to determine data entry methods-single or double keying. Of this sample, 3 keyed data once, 9 keyed twice, and 10 did not supply this level of detail. A followup mail and telephone survey is being conducted to supplement this information and to obtain data on error rates experienced. Other coordinating centers, identified through the Clinical Trials Resource Center Registry maintained by the Johns Hopkins Center for Clinical Trials, will also be included in the followup survey. Findings from the surveys will be presented, including guidelines distilled from the collective experience of centers using various data entry methods for different study and data management system designs.