- Email: [email protected]
An experiment to determine the worth of double-entry verification in the CAST data entry system
244
Abstracts sent study drug according to a randomization schedule, receiving the drug within 24 hours of the phone call. At the conclusion of the study statistical analyses of baseline treatment group homogeneity showed treatment groups to be comparable at baseline with respect to demographic, physical, and endoscopic characteristics, verifying the randomization. In addition, an analysis of treatment-by-investigator interaction found no significant differences between the groups in any of the primary efficacy variables.
An Experiment to Determine the Worth of Double-Entry Verification in the CAST Data Entry System R o b i n R e y n o l d s - H a e r t l e , R u t h McBride a n d C A S T C o o r d i n a t o r s University of Washington, Seattle, Washington (07) Twenty-seven clinics in the Cardiac Arrhythmia Suppression Trial (CAST) participated in a crossover design experiment to determine whether Double Entry Verification (DEV) w h e n compared with Single Entry (SE) is worthwhile in terms of the potential increased accuracy of data versus the additional time required. Clinics were randomly assigned to (a) 2 weeks of SE followed by 2 weeks of DEV or (b) 2 weeks of DEV followed by 2 weeks of SE. The total amount of time spent was significantly more with DEV (4.53 sec/field DEV vs 3.34 sec/field SE, p < 0.0005) but cost only $20 per clinic per month. DEV changed 6/1000 fields. Assuming 3/1000 were errors, this is much larger than acceptable (5/10,000 reported by Coronary Artery Surgery Study: CASS). Actual error rates for SE and DEV will be calculated by comparing data forms with entered data and qualitative assessment from the clinics will be compiled. Preliminary sampling indicates that DEV is worthwhile even considering the extensive checking provided by state-of-the-art microcomputer-based data entry.
Clinical Data Management for an International File M a t s M. L 6 r s t a d
H?issle, M6Indal, Sweden (08) In 1986, research in Hassle produced two NDA-files for original products (felodipine and omeprazole) submitted worldwide to national authorities. The clinical research was carried out in multinational/center trials engaging the research units in several companies in the Astra group. This presentation defines the role of the partners and how their contributions were coordinated. A desirable characteristic of NDA documentation is consistency in various study results. Demanding questions for clarification from authorities concern comparisons between study results requiring further analysis of raw data. To handle this situation it is imperative that the setup of the local databases is centrally controlled. The basic rule is that Hassle has full responsibility for the complete database. Procedures are set up to ensure that the database is complete at all times. Also, it is designed so as to allow for unscheduled comparisons and merging of results. Data quality is safeguarded by manual editing by the trial monitors (TM) and computerized validation. The validation routines are set up jointly by the local and the central staff. In this way, consistency in procedures over different studies is built into the system. The assessment of the data quality is based upon "clean-file" runs; a set of programs displaying, for each separate variable and important pairs of variables, the distributions and their parameters, lists of outliers, etc. When all suspected cases have been confirmed or corrected with an explanation, and when all decisions have been made on how individual data are to be interpreted, the treatment code is broken. After this, such decisions are not changed. The database is then used for table production and statistical analyses. The statistician appointed for the study prepares a separate statistical report. The responsibility for producing the final integrated report of each study rests with TM. The reporting utilizes the statistical report as a major input and benefits from close cooperation with the data base manager. The reports are finalized by the medically and statistically responsible persons and signed by each of them.
Distributed Data Management in NGHS: A Progress Report Bruce A. B a r t o n a n d Ellis J. C l a r k e
Maryland Medical Research Institute, Baltimore, Maryland (09) The NHLBI-sponsored Growth and Health Study (NGHS) has implemented a distributed data
Abstracts sent study drug according to a randomization schedule, receiving the drug within 24 hours of the phone call. At the conclusion of the study statistical analyses of baseline treatment group homogeneity showed treatment groups to be comparable at baseline with respect to demographic, physical, and endoscopic characteristics, verifying the randomization. In addition, an analysis of treatment-by-investigator interaction found no significant differences between the groups in any of the primary efficacy variables.
An Experiment to Determine the Worth of Double-Entry Verification in the CAST Data Entry System R o b i n R e y n o l d s - H a e r t l e , R u t h McBride a n d C A S T C o o r d i n a t o r s University of Washington, Seattle, Washington (07) Twenty-seven clinics in the Cardiac Arrhythmia Suppression Trial (CAST) participated in a crossover design experiment to determine whether Double Entry Verification (DEV) w h e n compared with Single Entry (SE) is worthwhile in terms of the potential increased accuracy of data versus the additional time required. Clinics were randomly assigned to (a) 2 weeks of SE followed by 2 weeks of DEV or (b) 2 weeks of DEV followed by 2 weeks of SE. The total amount of time spent was significantly more with DEV (4.53 sec/field DEV vs 3.34 sec/field SE, p < 0.0005) but cost only $20 per clinic per month. DEV changed 6/1000 fields. Assuming 3/1000 were errors, this is much larger than acceptable (5/10,000 reported by Coronary Artery Surgery Study: CASS). Actual error rates for SE and DEV will be calculated by comparing data forms with entered data and qualitative assessment from the clinics will be compiled. Preliminary sampling indicates that DEV is worthwhile even considering the extensive checking provided by state-of-the-art microcomputer-based data entry.
Clinical Data Management for an International File M a t s M. L 6 r s t a d
H?issle, M6Indal, Sweden (08) In 1986, research in Hassle produced two NDA-files for original products (felodipine and omeprazole) submitted worldwide to national authorities. The clinical research was carried out in multinational/center trials engaging the research units in several companies in the Astra group. This presentation defines the role of the partners and how their contributions were coordinated. A desirable characteristic of NDA documentation is consistency in various study results. Demanding questions for clarification from authorities concern comparisons between study results requiring further analysis of raw data. To handle this situation it is imperative that the setup of the local databases is centrally controlled. The basic rule is that Hassle has full responsibility for the complete database. Procedures are set up to ensure that the database is complete at all times. Also, it is designed so as to allow for unscheduled comparisons and merging of results. Data quality is safeguarded by manual editing by the trial monitors (TM) and computerized validation. The validation routines are set up jointly by the local and the central staff. In this way, consistency in procedures over different studies is built into the system. The assessment of the data quality is based upon "clean-file" runs; a set of programs displaying, for each separate variable and important pairs of variables, the distributions and their parameters, lists of outliers, etc. When all suspected cases have been confirmed or corrected with an explanation, and when all decisions have been made on how individual data are to be interpreted, the treatment code is broken. After this, such decisions are not changed. The database is then used for table production and statistical analyses. The statistician appointed for the study prepares a separate statistical report. The responsibility for producing the final integrated report of each study rests with TM. The reporting utilizes the statistical report as a major input and benefits from close cooperation with the data base manager. The reports are finalized by the medically and statistically responsible persons and signed by each of them.
Distributed Data Management in NGHS: A Progress Report Bruce A. B a r t o n a n d Ellis J. C l a r k e
Maryland Medical Research Institute, Baltimore, Maryland (09) The NHLBI-sponsored Growth and Health Study (NGHS) has implemented a distributed data