CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie

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Clinical Trial Code: <strong>SPACE</strong> 2 Version: 10. October 2008 Final 7.5 Expedited reporting SAEs, and OEs resulting in death or being life-threatening will be reported to the ethics committee (EC) according to EC standing rules and to all participating investigators. 8 DATA MANAGEMENT 8.1 Data collection All findings including clinical and laboratory data will be documented in the subject's medical record and in the electronic CRF. The electronic CRF has a series of inbuilt validation routines and plausibility checks. The investigator will be immediately informed if the data entered does not comply with the data validation rules. The fully entered parts of the CRF will be mailed as encoded PDF-Files to the main investigator of the specific site. The PDF can be printed and support monitoring activities at the study site. A second check will be performed by the data management which triggers the query process. Queries will be sent directly to the investigator and a copy to the monitor. The investigator is responsible for ensuring that all sections of the CRF are completed correctly and that entries can be verified against source data. 8.2 Data handling Data handling is described in detail in the Data Management Plan and the Data Validation Plan. Each study site will have secured internet access to the electronic study data base. The data will be entered directly to the database. During entering a series of data check will be run automatically and the person entering the data will be reminded immediately if there are specific errors or inconsistencies. These data checks will be formulated in the data validation plan. After finishing specific parts of the eCRF the study site will get a PDF with the patient data via an encoded email. A more thorough data check will be performed by the data management. This second view generates the queries which are sent to the study site as well as to the monitor. A responsible investigator will be obliged either to correct the implausible data or to confirm its authenticity and to give appropriate explanation. If not corrected, the data will be flagged, rendering a check of all questionable entries conveniently possible. A responsible monitor will check all flagged data and will generate questions, which will be _______________________________________________________________________________________________________ Page 28 of 49
Clinical Trial Code: <strong>SPACE</strong> 2 Version: 10. October 2008 Final sent back to the responsible investigator. The investigator will have to resolve all 'discrepancies'. Further checks for plausibility, consistency, and completeness of the data will be performed after completion of the study. Queries will be generated on the basis of these checks combined with a visual control by a responsible monitor/data manager.] All missing data or inconsistencies will be reported back to the center(s) and clarified by the responsible investigator. If no further corrections are to be made in the database it will be declared closed and used for statistical analysis. All data management activities will be done according to the current Standard Operating Procedures (SOPs) of the IBE. 8.3 Storage and archiving of data All important trial documents (e.g. Investigator Site File, subject identification log, CRF) will be archived for at least 10 years after the end of the trial. 9 DATA ANALYSIS / STATISTICAL METHODS 9.1 Sample size calculation Sample size calculations were performed for the efficacy endpoints. Since a hierarchical testing procedure is used, a 5% significance level for each step of the procedure can be chosen. The first level consists of two simultaneously performed tests. In order to assure an overall level of 5% for this step, the closed testing procedure is used and the two comparisons CAS versus BMT and CEA versus BMT are performed as two-sided tests with α=2.5%. The event rate of CAS (as well as CEA) is assumed to be 6.4% (combining short-term and 5-year event rates). The BMT event rate is set to 11.8%. The sample size in the CAS (CEA) arm is twice the number of patients in the BMT arm. The power of each comparison is set to 90%. We need a high chance to show simultaneously superiority for CEA as well as CAS in comparison with BMT in order to clinically interpret the non-inferiority aimed at the second step of the procedure. The comparison needs 1,080 patients in the CAS and the CEA and 540 patients in the BMT arm when a two group continuity corrected chi-square test is used. For this scenario (1,080/1,080), a two-sided significance level of α=5%, and a non-inferiority margin of 2.5% implies for the non-inferiority assessment between CAS and CEA a power of 66%. A power of 80% for the non-inferiority test is reached with a sample size of 1,505 patients in each group (CAS/CEA). _______________________________________________________________________________________________________ Page 29 of 49
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