User Certificates

Preparation of ICH conform study reports using text templates and the ICH report manager.

idv contributes the following:

• Upgrade of the ICH Study Manager witha complete model report and instructions for proceeding.
• Tutorial with exercise data for evaluations and report preparation in accordance with GCP.
• Certification dataset for independent evaluation and report preparation.
• Review and examination of the results
• Awarding of the certificate ?Master of Clinical Trials? for each area of interest.

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Disposition of patients and study conduct

• ?Disposition of Patients and Study Conduct? (text, flowchart, tables).
• Dropouts. Protocol violations (criteria for inclusion and exclusion, schedule, compliance, classification as minor, major, severe).
• Operationalizing of the datasets / populations (safety, ITT, full analysis set, PP).
• Evaluation of compliance.
• Time window for doctors? visits, ?exposure time?.
• Complete presentation scheme with currently recommended definitions.

Baseline characteristics

• Accurate accomplishment of studies by means of non-parametric and classical descriptive methods.
• Graphical presentation of the results by means of effect sizes and confidence intervals.
• Validated import of tables and figures into the Clinical Study Report.
• Identification of inhomogeneities.
• Correct description and interpretation of the results.

Efficacy criteria: Descriptive analysis

• Accurate accomplishment of modern descriptive analyses regarding continuous data, score values and binary data.
• Validated import of the results into the Clinical Study Report.
• Creation of graphical analyses in accordance with the state-of-the-art biometry.
• Description and interpretation of methods used and results given in the Clinical Study Report.

Efficacy criteria: Teststatistical analysis

• Template for modern robust / non-parametric procedures in accordance with ICH E9.
• Test for difference and test for equivalence / non-inferiority.
• Effect size and confidence intervals.
• Tables and graphical representations.
• Correct multi-center analyses and adjustments with respect to baseline-inhomogeneities.
• Description of the methods and correct interpretation of the results.

Evaluation of laboratory values

• Generating tables (absolute, changes from baseline, percent changes, treatment of abnormal values, establishing of sign tests, shift tables, graphics).
• Correct description of methods.
• Standardized presentations/interpretation of the results in the study report according to ICH E3.

Rescue medication

• How to detect and evaluate a study nuisance factor like rescue medication.

 There are other certificates for REPORT and TESTIMATE