Cover Page
Table of Contents
PART 1- Creating Data Collection Forms
Chapter 1. An Overall Approach: Building a Library of Forms
Chapter 2. Types of Data Collection Forms
Chapter 3. Choosing Modules and Designing Forms: Guidelines, Pointers, and Pitfalls
Chapter 4. Preparing the Data Collection Form Package
Chapter 5. Reproducing and Assembling Forms
Chapter 6. Remote Data Entry Forms
Chapter 7. Data Processing and Storage of Completed Forms
Chapter 8. Selected Issues
PART 2- Examples of Data Collection Forms
Introduction to Part 2
A. BACKGROUND OF A CLINICAL TRIAL
A1. INSTRUCTIONS FOR COMPLETING DATA COLLECTION FORMS
A2. TIME-AND-EVENTS SCHEDULES
A3. DEMOGRAPHICS
A4. GENERAL MEDICAL HISTORY
A5. SPECIFIC TYPES OF MEDICAL HISTORIES
A6. MEDICATION HISTORY
A7. INCLUSION AND EXCLUSION CRITERIA
B. PHYSICAL AND OTHER EXAMINATIONS
B1. PHYSICAL EXAMINATIONS
B2. VITAL SIGNS
B3. NEUROLOGICAL EXAMINATIONS
B4. OPHTHALMOLOGICAL EXAMINATIONS
B5. PSYCHOLOGICAL AND PSYCHIATRIC TESTS
B6. OTHER SPECIALIZED PHYSICAL EXAMINATIONS
C. LABORATORY TESTS AND EVALUATIONS
C1. CLINICAL CHEMISTRY AND HEMATOLOGY TESTS
C2. RADIOLOGY AND PATHOLOGY REPORTS
C3. ELECTROCARDIOGRAMS
C4. URINE TESTS
C5. MICROBIOLOGY TESTS
C6. VIROLOGY TESTS
C7. NEUROLOGY TESTS
C8. ENDOCRINOLOGY AND IMMUNOLOGY TESTS
C9. OTHER LABORATORY TESTS
D. ADVERSE EVENTS (EXPERIENCES)
D ADVERSE EVENTS (EXPERIENCES)
MEDICAL EVENT FORM
TOXICITY/ADVERSE DRUG REACTION REPORT FORM
E. MEDICINES AND ASSAYS OF BIOLOGICAL LEVELS
E1. Dosing and Dispensing Records
E2. CONCOMITANT MEDICATIONS
E3. PHARMACOKINETIC SAMPLES TO ASSAY
F. EFFICACY
F1. EFFICACY EVALUATIONS
F2. COMPLIANCE
F3. PATIENT DIARIES
G. PATIENT TAERMINATION AND MISCELLANEOUS FORMS
G1. TERMINATION AND PREMATURE PATIENT DISCONTINUATION
G2. GLOBAL CLINICAL IMPRESSIONS
G3. ADDITIONAL AND UNSCHEDULED PATIENT VISITS
G4. COMMENT LOG AND INVESTIGATOR VERIFICATION FORMS
References
Subject Index