ENROLL-DOC-2009-EN-1.0
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1 y ENROLL-DOC-2009-EN-1.0 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset Enroll-HD A worldwide observational study for Huntington s disease families A CHDI Foundation Project
2 Table of Contents 1 Purpose of this Document 3 2 Forms and Data Files 4 3 Form Enrollment 5 4 Form Variable Items 6 5 Form UHDRS Motor/Diagnostic Confidence (Motor) 7 6 Form UHDRS Total Funtional Capacity (TFC) 12 7 Form UHDRS Functional Assessment/Independence Scale (Function) 13 8 Form Mini Mental State Examination (MMSE) 14 9 Form Core and Extended Cognitive Assessment (Cognitive) 15 Revision History 18 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 2/18
3 1 Purpose of this Document The purpose of this document is to provide an annotated view of the ecrf (electronic Case Report Form) of Enroll-HD s Ad Hoc Visits. It shows the source of the variable names provided in the Enroll- HD plus periodic dataset, which is available to the HD research community at large. The periodic dataset represents a data extract of the Enroll-HD Electronic Data Capture (EDC) database at a defined point in time. Information that could potentially identify a participant has been removed or de-identified within this dataset. When available, CISC SDMT naming conventions were used. The annotated view shows all forms, variables, and variable names used within the periodic dataset. Forms and variables that are not provided in the dataset are not shown in the annotated forms. Variables that have been transformed for de-identification reasons are shown in the transformed manner in the annotated view. The variables and data files of the dataset are described in detail within the data dictionary for the Enroll-HD plus periodic dataset. Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 3/18
4 2 Forms and Data Files Forms are CRF entry screens that are displayed to data entry personnel and show how data is entered in the ecrf. Data files are sets of variables that define how the data are represented. The following table defines how forms and data files are related. Form / Data File Profile Participation Enrollment Variable Motor TFC Function Cognitive MMSE Ad Hoc The data files Profile and Participation are not displayed on an entry form but consist of variables of various forms. It contains key information like subject, study and region identifers and some visit-independent subject information, e.g. the subject s latest HD classification. Please refer to the data dictionary for detailed information. Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 4/18
5 3 Form Enrollment Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 5/18
6 4 Form Variable Items Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 6/18
7 5 Form UHDRS Motor/Diagnostic Confidence (Motor) Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 7/18
8 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 8/18
9 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 9/18
10 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 10/18
11 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 11/18
12 6 Form UHDRS Total Funtional Capacity (TFC) Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 12/18
13 7 Form UHDRS Functional Assessment/Independence Scale (Function) Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 13/18
14 8 Form Mini Mental State Examination (MMSE) Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 14/18
15 9 Form Core and Extended Cognitive Assessment (Cognitive) Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 15/18
16 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 16/18
17 Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset 17/18
18 Revision History Version R1 Summary of Changes Initial version of annotated CRF for the Ad Hoc dataset. Annotated Case Report Form (CRF) for Ad Hoc Periodic Dataset
Enroll-HD Plus Data Handling Manual
Version 2016-10-R1 Enroll-HD A worldwide observational study for Huntington s disease families A CHDI Foundation Project CONTENTS 1. PURPOSE OF THIS DOCUMENT... 3 2. DATASET CONSIDERATIONS... 3 2.1 Data
Enroll-HD Data Handling Manual
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