Get VA 10-9012 1989-2024

Plate or give name - last first middle 21. APPROVED BY A. SUBCOMMITTEE ON HUMAN STUDIES B. RESEARCH AND DEVELOPMENT COMMITTEE VA FORM NOV 1989 10-9012 SUPERSEDES EXISTING STOCK OF VA FORM 10-9012 AUG 1982 WILL BE USED. 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 NO If Yes complete Item 9B YES 5. MANUFACTURER OR OTHER SPONSOR 9B. CLASSIFICATION 10. STABILITY AND STORAGE REQUIREMENTS A. PRIOR TO MIXING STORAGE SHOULD BE Check applicable box es AT ROOM TEMPERATURE IN REFRIGERATOR IN FREEZER PROTECTED FROM LIGHT OTHER Specify B. AFTER MIXING DRUG REMAINS STABLE IN REFRIGERATOR FOR Check appropriate box and enter quantity MINUTES HOURS DAYS 11. DRUG ADMINISTRATION PROCEDURES A. ROUTES OF ADMINISTRATION Check appropriate box es C. RECONSTITUTION DIRECTIONS B. ADMINISTRATION DIRECTIONS I. V. INFUSION ORAL I. V. PUSH 12B. ROUTE 13. USUAL DOSAGE RANGE B. PROFESSIONAL NURSE A. PHYSICIAN ONLY 14. KNOWN SIDE EFFECTS AND TOXICITIES I5A. DOUBLE BLIND NO 15B. NAME OF INDIVIDUAL WHO HAS CODE DESIGNATION 15C. TELEPHONE NUMBERS DAYTIME EVENING If YES complete Items 15B and 15C 16. SPECIAL PRECAUTIONS Include drug interactions synergisms antagonisms contraindications etc* 17. ANTIDOTE 18. STATUS Check one PHASE II COMMERCIALLY AVAILABLE 0THER Specify 19. NAMES OF AUTHORIZED PRESCRIBERS A. B. C. D. 20. SIGNATURE OF RESPONSIBLE OR PRINCIPAL INVESTIGATOR DATE 22. PATIENT IDENTIFICATION I. D. 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. 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. 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 NO If Yes complete Item 9B YES 5. DOSAGE FORMS AND STRENGTHS 9A. IS THIS DRUG A CONTROLLED SUBSTANCE NO If Yes complete Item 9B YES 5. MANUFACTURER OR OTHER SPONSOR 9B. CLASSIFICATION 10. STABILITY AND STORAGE REQUIREMENTS A. PRIOR TO MIXING STORAGE SHOULD BE Check applicable box es AT ROOM TEMPERATURE IN REFRIGERATOR IN FREEZER PROTECTED FROM LIGHT OTHER Specify B. MANUFACTURER OR OTHER SPONSOR 9B. CLASSIFICATION 10. STABILITY AND STORAGE REQUIREMENTS A. PRIOR TO MIXING STORAGE SHOULD BE Check applicable box es AT ROOM TEMPERATURE IN REFRIGERATOR IN FREEZER PROTECTED FROM LIGHT OTHER Specify B. AFTER MIXING DRUG REMAINS STABLE IN REFRIGERATOR FOR Check appropriate box and enter quantity MINUTES HOURS DAYS 11. .