Fillable Printable VA Form 10-9012
Fillable Printable VA Form 10-9012
VA Form 10-9012
C. RECONSTITUTION DIRECTIONS
6. SOURCE OF DRUG (If other than manufacturer or sponsor)
1. TITLE OF STUDY
2. RESPONSIBLE INVESTIGATOR (Individual who signed Form FD-1573)
3. PRINCIPAL INVESTIGATOR (If different than responsible investigator)
7. THERAPEUTIC CLASSIFICATION AND EXPECTED THERAPEUTIC
EFFECT(S)
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)
9B. CLASSIFICATION5. MANUFACTURER OR OTHER SPONSOR
10. STABILITY AND STORAGE REQUIREMENTS
A. PRIOR TO MIXING, STORAGE SHOULD BE (Check applicable box(es))
OTHER
(Specify)
AT ROOM TEMPERATURE
IN REFRIGERATOR
IN FREEZER
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
I.V. INFUSION
ORAL
13. USUAL DOSAGE RANGE
12B. ROUTE
12A. DRUG ADMINISTERED BY (Also complete Item 12B)
B. PROFESSIONAL NURSE
A. PHYSICIAN ONLY
14. KNOWN SIDE EFFECTS AND TOXICITIES
15B. NAME OF INDIVIDUAL WHO HAS CODE DESIGNA-
TION
I5A. DOUBLE BLIND?
15C. TELEPHONE NUMBERS
DAYTIME
EVENING
(If "YES" complete
Items 15B and 15C)
YES
16. SPECIAL PRECAUTIONS (Include drug interactions (synergisms, antagonisms), contraindications, etc.)
17. ANTIDOTE
18. STATUS (Check one)
COMMERCIALLY AVAILABLE
PHASE II
INVESTIGATIONAL
PHASE I
PHASE III
0THER (Specify)
19. NAMES OF AUTHORIZED PRESCRIBERS
A. B.
C.
D.
DATE
22. PATIENT IDENTIFICATION (I.D. plate or give name - last, first, middle20. SIGNATURE OF RESPONSIBLE OR PRINCIPAL INVESTIGATOR
21. APPROVED BY
A. SUBCOMMITTEE ON HUMAN STUDIES
DATE
21A. SIGNATURE OF CHAIRPERSON
B. RESEARCH AND DEVELOPMENT COMMITTEE
DATE
21B. SIGNATURE OF CHAIRPERSON
10-9012
VA FORM
NOV 1989
I.V.PUSH
NO
SUPERSEDES EXISTING STOCK OF VA FORM 10-9012, AUG 1982,
WILL BE USED.
INVESTIGATIONAL DRUG INFORMATION RECORD
B. ADMINISTRATION DIRECTIONSA. ROUTES OF ADMINISTRATION
(Check appropriate box(es))
