Va Form 10-9012 - Investigational Drug Information Record

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INVESTIGATIONAL DRUG INFORMATION RECORD
1. TITLE OF STUDY
6. SOURCE OF DRUG (If other than manufacturer or sponsor)
2. RESPONSIBLE INVESTIGATOR (Individual who signed Form FD-1573)
7. THERAPEUTIC CLASSIFICATION AND EXPECTED THERAPEUTIC
EFFECT(S)
3. PRINCIPAL INVESTIGATOR (If different than responsible investigator)
4. ALL DESIGNATIONS FOR DRUG (Generic and chemical, code, trade-names, other
designations)
8. DOSAGE FORMS AND STRENGTHS
9A. IS THIS DRUG A CONTROLLED SUBSTANCE?
YES
NO (If "Yes," complete Item 9B)
5. MANUFACTURER OR OTHER SPONSOR
9B. CLASSIFICATION
10. STABILITY AND STORAGE REQUIREMENTS
A. PRIOR TO MIXING, STORAGE SHOULD BE (Check applicable box(es))
OTHER
AT ROOM TEMPERATURE
IN REFRIGERATOR
IN FREEZER
(Specify)
PROTECTED FROM LIGHT
B. AFTER MIXING, DRUG REMAINS STABLE IN REFRIGERATOR FOR (Check appropriate box and enter quantity)
MINUTES
HOURS
DAYS
11. DRUG ADMINISTRATION PROCEDURES
C. RECONSTITUTION DIRECTIONS
A. ROUTES OF ADMINISTRATION
B. ADMINISTRATION DIRECTIONS
(Check appropriate box(es))
I.V. INFUSION
ORAL
I.V.PUSH
13. USUAL DOSAGE RANGE
12A. DRUG ADMINISTERED BY (Also complete Item 12B)
12B. ROUTE
A. PHYSICIAN ONLY
B. PROFESSIONAL NURSE
14. KNOWN SIDE EFFECTS AND TOXICITIES
I5A. DOUBLE BLIND?
15B. NAME OF INDIVIDUAL WHO HAS CODE DESIGNA-
15C. TELEPHONE NUMBERS
TION
DAYTIME
EVENING
(If "YES" complete
NO
Items 15B and 15C)
YES
16. SPECIAL PRECAUTIONS (Include drug interactions (synergisms, antagonisms), contraindications, etc.)
17. ANTIDOTE
18. STATUS (Check one)
COMMERCIALLY AVAILABLE
INVESTIGATIONAL
PHASE II
PHASE I
PHASE III
0THER (Specify)
19. NAMES OF AUTHORIZED PRESCRIBERS
A.
B.
C.
D.
20. SIGNATURE OF RESPONSIBLE OR PRINCIPAL INVESTIGATOR
22. PATIENT IDENTIFICATION (I.D. plate or give name - last, first, middle
DATE
21. APPROVED BY
A. SUBCOMMITTEE ON HUMAN STUDIES
DATE
21A. SIGNATURE OF CHAIRPERSON
B. RESEARCH AND DEVELOPMENT COMMITTEE
DATE
21B. SIGNATURE OF CHAIRPERSON
VA FORM
SUPERSEDES EXISTING STOCK OF VA FORM 10-9012, AUG 1982,
10-9012
NOV 1989
WILL BE USED.

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