ENROLL-DOC-2009-EN-1.0
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1 ENROLL-DOC-2009-EN-1.0 Annotated Case Report Form (CRF) for REGISTRY 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 4 2 Forms and Data Files 5 3 Form Enrollment (R3) 7 4 Form Enrollment (R2) 8 5 Form Demographics (Demog) 9 6 Form HD Clinical Characteristics (HD CC) 10 7 Form Pharmacotherapy (PharmacoTx) 13 8 Form Nutritional Supplements (NutSuppl) 14 9 Form Non-Pharmacologic Therapies (NonPharmaTx) Form Comorbid Conditions (Comorbid) Form Mortality Form Variable Items - Baseline Visit (Variable BL) (R3) Form Variable Items - Baseline Visit (Variable BL) (R2) Form Variable Items - Follow-Up Visit (Variable FUP) (R3) Form Variable Items - Follow-Up Visit (Variable FUP) (R2) Form UHDRS Motor/Diagnostic Confidence (Motor) Form UHDRS Total Funtional Capacity (TFC) Form UHDRS Functional Assessment/Independence Scale (Function) Form Problem Behaviours Assessment Short (PBA-s) Form Core and Extended Cognitive Assessment (Cognitive) (R3) Form Core and Extended Cognitive Assessment (Cognitive) (R2) Form Premature End of Study (End) Form Hospital Anxiety and Depression Scale/Snaith Irritability Scale (HADS-SIS) 50 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 2/68
3 24 Form Short Form Health Survey 36v1 (SF-36) Form Short Form Health Survey 36v2 (SF-36) Form CSSRS-BL Form CSSRS-FUP Form Behaviour (R3) Form Behaviour (R2) Form Hamilton 67 Revision History 68 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 3/68
4 1 Purpose of this Document The purpose of this document is to provide an annotated view of the REGISTRY s ecrf (electronic Case Report Form) within the Enroll-HD system. It shows the source of the variable names provided in the Enroll-HD 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,cdisc 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 REGISTRY Periodic Dataset 4/68
5 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. Enrollment Demog HD CC PharmacoTx NutSuppl NonPharmacoTx Comorbid End Mortality Pharmaco Tx NutSuppl Form / Data File Profile Participation NonPharmacoTx Comorbid R3 R2 Variable BL Variable FUP Motor TFC Function Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 5/68
6 PBA-s Pharmaco Tx NutSuppl Form / Data File Profile Participation NonPharmacoTx Comorbid R3 R2 Cognitive HADS-SIS SF36-v1 SF36-v2 HADS-SIS CSSRS BL CSSRS FUP Behaviour BDI Hamilton 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 REGISTRY Periodic Dataset 6/68
7 3 Form Enrollment (R3) Variable hdcat Label of the variable hdcat Coded value 2 of variable hdcat, item pre-manifest [..] Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 7/68
8 4 Form Enrollment (R2) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 8/68
9 5 Form Demographics (Demog) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 9/68
10 6 Form HD Clinical Characteristics (HD CC) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 10/68
11 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 11/68
12 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 12/68
13 7 Form Pharmacotherapy (PharmacoTx) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 13/68
14 8 Form Nutritional Supplements (NutSuppl) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 14/68
15 9 Form Non-Pharmacologic Therapies (NonPharmaTx) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 15/68
16 10 Form Comorbid Conditions (Comorbid) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 16/68
17 11 Form Mortality Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 17/68
18 12 Form Variable Items - Baseline Visit (Variable BL) (R3) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 18/68
19 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 19/68
20 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 20/68
21 13 Form Variable Items - Baseline Visit (Variable BL) (R2) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 21/68
22 14 Form Variable Items - Follow-Up Visit (Variable FUP) (R3) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 22/68
23 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 23/68
24 This table contains information about value of Participant Category, Occupation, etc. populated from the previous visit Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 24/68
25 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 25/68
26 15 Form Variable Items - Follow-Up Visit (Variable FUP) (R2) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 26/68
27 16 Form UHDRS Motor/Diagnostic Confidence (Motor) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 27/68
28 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 28/68
29 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 29/68
30 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 30/68
31 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 31/68
32 17 Form UHDRS Total Funtional Capacity (TFC) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 32/68
33 18 Form UHDRS Functional Assessment/Independence Scale (Function) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 33/68
34 19 Form Problem Behaviours Assessment Short (PBA-s) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 34/68
35 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 35/68
36 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 36/68
37 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 37/68
38 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 38/68
39 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 39/68
40 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 40/68
41 20 Form Core and Extended Cognitive Assessment (Cognitive) (R3) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 41/68
42 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 42/68
43 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 43/68
44 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 44/68
45 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 45/68
46 21 Form Core and Extended Cognitive Assessment (Cognitive) (R2) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 46/68
47 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 47/68
48 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 48/68
49 22 Form Premature End of Study (End) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 49/68
50 23 Form Hospital Anxiety and Depression Scale/Snaith Irritability Scale (HADS-SIS) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 50/68
51 24 Form Short Form Health Survey 36v1 (SF-36) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 51/68
52 25 Form Short Form Health Survey 36v2 (SF-36) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 52/68
53 26 Form CSSRS-BL Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 53/68
54 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 54/68
55 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 55/68
56 27 Form CSSRS-FUP Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 56/68
57 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 57/68
58 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 58/68
59 28 Form Behaviour (R3) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 59/68
60 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 60/68
61 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 61/68
62 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 62/68
63 29 Form Behaviour (R2) Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 63/68
64 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 64/68
65 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 65/68
66 Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 66/68
67 30 Form Hamilton Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset 67/68
68 Revision History Version R1 Summary of Changes Initial version of annotated CRF for the first REGISTRY Periodic Dataset. Annotated Case Report Form (CRF) for REGISTRY Periodic Dataset
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