Актуальная Медицина - EXAMPLE OF CLINICAL STUDY PROTOCOL

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1.0 Title Page
CLINICAL STUDY PROTOCOL…………..
A Multi-Center, Open-Label Study of the Fully Human
Anti-TNF Monoclonal …….for the
Induction and Maintenance of Clinical Remission in
Subjects with Moderate to Severe Crohn's Disease
Abbott Number /
Investigational Product:

Date: 
Development Phase: 
EudraCT Number: 
Investigator: Multicenter-----
Sponsor: 
Sponsor/Emergency
Contact:
Confidential Information
No use or disclosure outside Abbott is permitted without prior written authorization from Abbott.
2
2.0 Table of Contents
1.0 Title Page................................................................................. 1
2.0 Table of Contents.................................................................... 2
3.0 Introduction ............................................................................ 6
4.0 Study Objective..................................................................... 11
5.0 Investigational Plan.............................................................. 12
5.1 Overall Study Design and Plan: Description..........................................12
5.2 Selection of Study Population .................................................................16
5.2.1 Inclusion Criteria .....................................................................................16
5.2.2 Exclusion Criteria....................................................................................17
5.2.3 Prior and Concomitant Therapy ..............................................................20
5.2.3.1 Prior Therapy...........................................................................................20
5.2.3.2 Concomitant Therapy ..............................................................................21
5.2.3.3 Prohibited Therapy ..................................................................................22
5.3 Efficacy and Safety Assessments/Variables............................................22
5.3.1 Efficacy and Safety Measurements Assessed and Flow Chart................23
5.3.1.1 Study Procedures .....................................................................................27
5.3.2 Drug Concentration Measurements.........................................................35
5.3.3 Efficacy Variables ...................................................................................35
5.3.4 Safety Variables.......................................................................................35
5.4 Removal of Subjects from Therapy or Assessment ................................36
5.4.1 Discontinuation of Individual Subjects ...................................................36
5.4.2 Discontinuation of Entire Study ..............................................................36
5.5 Treatments...............................................................................................37
5.5.1 Treatments Administered ........................................................................37
5.5.2 Identity of Investigational Product ..........................................................38
5.5.2.1 Packaging and Labeling ..........................................................................38
5.5.2.2 Storage and Disposition of Study Drug...................................................39
5.5.3 Method of Assigning Subject Treatment.................................................40
5.5.4 Selection and Timing of Dose for Each Subject .....................................40
5.5.5 Blinding ...................................................................................................41
5.5.6 Treatment Compliance ............................................................................41
5.5.7 Drug Accountability ................................................................................41
5.6 Discussion and Justification of Study Design .........................................42
5.6.1 Discussion of Study Design and Choice of Control Groups ...................42
5.6.2 Appropriateness of Measurements ..........................................................43
5.6.3 Suitability of Subject Population.............................................................43
5.6.4 Selection of Doses in the Study...............................................................43
6.0 Adverse Events ..................................................................... 44
6.1 Definitions...............................................................................................44
6.1.1 Adverse Event .........................................................................................44
6.1.2 Serious Adverse Events...........................................................................45
6.2 Adverse Event Severity ...........................................................................46
6.3 Relationship to Study Drug .....................................................................46
6.4 Adverse Event Collection Period ............................................................47
6.5 Adverse Event Reporting ........................................................................48
6.6 Pregnancy ................................................................................................49
7.0 Protocol Deviations............................................................... 49
8.0 Statistical Methods and Determination of Sample
Size ......................................................................................... 51
8.1 Statistical and Analytical Plans ...............................................................51
8.1.1 Analysis Populations ...............................................................................51
8.1.2 Safety Analysis ........................................................................................51
8.1.3 Statistical Analyses of Efficacy...............................................................52
8.2 Determination of Sample Size.................................................................53
9.0 Ethics ..................................................................................... 54
9.1 Independent Ethics Committee (IEC) or Institutional Review
Board (IRB).............................................................................................54
9.2 Ethical Conduct of the Study...................................................................54
9.3 Subject Information and Consent ............................................................55
10.0 Source Documents and Case Report Form
Completion............................................................................ 55
10.1 Source Documents...................................................................................55
10.2 Case Report Forms ..................................................................................56
11.0 Data Quality Assurance....................................................... 56
12.0 Use of Information and Publication ................................... 58
12.1 Use of Information ..................................................................................58
12.2 Publication...............................................................................................58
13.0 Completion of the Study ...................................................... 59
14.0 Investigator's Agreement..................................................... 61
15.0 Reference List ....................................................................... 62
List of Tables
Table 1. Study Activities .......................................................................................24
Table 2. Clinical Laboratory Tests ........................................................................32
Table 3. Identity of Investigational Product ..........................................................38
Table 4. Study Drug Distribution ..........................................................................39
List of Figures
Figure 1. Study Design Schematic..........................................................................15
Figure 2. Adverse Event Collection........................................................................48
Adalimumab
M06-829 Protocol
EudraCT #: 2006-002078-23
5
List of Appendices
Appendix A. List of Abbreviations and Definition of Terms .......................................64
Appendix B. Documents Required Prior to Initiation of the Study..............................66
Appendix C. Responsibilities of the Clinical Investigator............................................68
Appendix D. CDC Treatment of Tuberculosis Infection (Preventive Therapy) ...........70
Appendix E. Non-Drug Materials Provided to the Study Site(s) .................................74
Appendix F. Harvey-Bradshaw Index..........................................................................75
Appendix G. Short Quality of Life in Inflammatory Bowel Disease
Questionnaire (SIBDQ) ...........................................................................76
Appendix H. Excluded Medications .............................................................................80
Appendix I. Day 70 Phone Call...................................................................................81
Appendix J. Work Productivity and Activity Impairment Questionnaire:
Specific Health Problem V2.0 (WPAI:SHP)...........................................82
Appendix K. Health Care Resource Utilization (Unscheduled Outpatient
Visits, Emergency Room Visits and Hospitalizations) ...........................84
Appendix L. Subject Adverse Experience Log ............................................................85
Appendix M. Subject Medication Log ..........................................................................86
Appendix N. Subject Dosing Diary ..............................................................................87
Appendix O. Crohn's Disease Activity Index Study Procedures ..................................88
Appendix P. Subject CDAI Diary ................................................................................90
Appendix Q. Crohn's Disease Activity Index (CDAI)..................................................91
Appendix R. Standard Weights.....................................................................................92

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