Document Name and Accession

Document Name: CLINICAL GLOBAL IMPRESSION SCALE
Document Accession: phd007438.1

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CLINICAL GLOBAL IMPRESSION SCALE

(7/19/05)

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SUBJECT ID VISIT NO   V
INITIALS SITE NO VISIT DATE MM DD YYYY
Link to associated variable1. SEVERITY OF ILLNESS OF DISEASE UNDER STUDY
Considering your total clinical experience with this particular population, how incapacitated has the subject been within the last week?
0 = Not assessed
1 = Normal, not at all incapacitated
2 = Borderline incapacitated
3 = Mildly incapacitated
4 = Moderately incapacitated
5 = Markedly incapacitated
6 = Severely incapacitated
7 = Among the most extremely incapacitated subjects

THE NEXT TWO ITEMS MAY BE OMITTED AT THE INITIAL ASSESSMENT BY MARKING "NOT ASSESSED" FOR BOTH ITEMS

Link to associated variable2. GLOBAL IMPROVEMENT - Rate total improvement whether or not, in your judgment, it is due entirely to drug treatment.
Compared to baseline, how much has the subject changed?
0 = Not assessed
1 = Very much improved
2 = Much improved
3 = Minimally improved
4 = No change
5 = Minimally worse
6 = Much worse
7 = Very much worse
Link to associated variable3. EFFICACY INDEX - Rate this item on the basis of DRUG EFFECT ONLY
Select the terms which best describe the degrees of therapeutic effect and side effects and record the number in the box where the two items intersect.

  • EXAMPLE: therapeutic effect is rated as "Moderate" and side effects are judged "Do not significantly interfere with subject's functioning." Record 06 in question 3.
    THERAPEUTIC EFFECTSIDE EFFECTS
    NoneDo not significantly interfere with subject's functioningSignificantly interferes with subject's functioningOutweighs therapeutic effect
    MARKED - Vast improvement
    Complete or nearly complete remission of all symptoms
    01020304
    MODERATE - Decided improvement. Partial remission of symptoms05060708
    MINIMAL - Slight improvement which doesn't alter status of care of subject09101112
    UNCHANGED OR WORSE13141516
    NOT ASSESSED = 00