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1 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | Form_10-9012_59.docx | Sun Aug 26 17:51:28 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | Form_10-9012_59.docx | Thu Nov 8 20:18:14 2018 UTC |
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1 | VA| | |
2 | ||
3 | U.S. Depar tment of V eterans Af fairs | |
4 | investigat ional drug informati on record | |
5 | 1. TITLE OF STUDY | |
6 | 6. SOURCE OF DRUG (I f other th an manufac turer or s ponsor) | |
7 | ||
8 | ||
9 | 2. RESPONS IBLE INVES TIGATOR (I ndividual who signed Form FD-1 573) | |
10 | 7. THERAPE UTIC CLASS IGICATION AND EXPECT ED THERAPE UTIC EFFEC T(S) | |
11 | ||
12 | ||
13 | 3. PRINCIP AL INVESTI GATOR (If different than respo nsible inv estigator) | |
14 | ||
15 | ||
16 | ||
17 | 4. ALL DES IGNATIONS FOR DRUG ( Generic an d chemical , code, tr ade-names, other des ignations) | |
18 | ||
19 | ||
20 | 8. DOSAGE FORMS AND STRENGTHS | |
21 | ||
22 | ||
23 | ||
24 | 9A. IS THI S DRUG A C ONTROLLED SUBSTANCE? | |
25 | ||
26 | YES | |
27 | NO | |
28 | (If “Yes,” complete item 9B) | |
29 | 5. MANUFAC TURER OR O THER SPONS OR | |
30 | 9B. CLASSI FICATION | |
31 | ||
32 | ||
33 | 10. STABIL ITY AND ST ORAGE REQU IREMENTS | |
34 | A. PRIOR T O MIXING, STORAGE SH OULD BE (C heck appli cable box( es)) | |
35 | AT ROOM T EMPERATURE | |
36 | IN REFRIG ERATOR | |
37 | IN FREEZE R | |
38 | PROTECTED FROM LIGH T | |
39 | OTHER (Sp ecify) | |
40 | ||
41 | B. AFTER M IXING, DRU G REMAINS STABIL IN REFRIGERAT OR FOR (Ch eck approp riate box and enter quantity) | |
42 | ||
43 | ||
44 | MINUTES | |
45 | ||
46 | ||
47 | HOURS | |
48 | ||
49 | ||
50 | DAYS | |
51 | ||
52 | 11. DRUG A DMINISTRAT ION PROCED URES | |
53 | A. ROUTES OF ADMINIS TRATION (C heck appro priate box es)) | |
54 | B. ADMINIS TRATION DI RECTIONS | |
55 | C. RECONST ITUTION DI RECTIONS | |
56 | ||
57 | ORAL | |
58 | ||
59 | I.V. INFUS ION | |
60 | ||
61 | ||
62 | ||
63 | I.V.PUSH | |
64 | ||
65 | ||
66 | ||
67 | ||
68 | 12A. DRUG ADMINISTER ED BY (Als o complete item 12B) | |
69 | 12B. Route | |
70 | 13. USUAL DOSAGE | |
71 | ||
72 | A. PHYSICI AN ONLY | |
73 | ||
74 | B. PROFESS IONAL NURS E | |
75 | ||
76 | ||
77 | 14. KNOWN SIDE EFFEC TS AND TOX ICITIES | |
78 | ||
79 | 15A. DOUBL E BLIND | |
80 | 15B. NAME OF INDIVID UAL WHO HA S CODE DES IGNATION | |
81 | 15C. TELEP HONE NUMBE RS | |
82 | ||
83 | YES | |
84 | ||
85 | NO | |
86 | (If “YES” complete I tems 15B a nd 15C) | |
87 | ||
88 | DAYTIME | |
89 | EVENING | |
90 | ||
91 | ||
92 | ||
93 | ||
94 | ||
95 | ||
96 | ||
97 | ||
98 | 16. SPECIA L PRECAUTI ONS (Inclu de drug in teractions (synergis ms, antago nisms), co ntraindica tions, etc .) | |
99 | ||
100 | 17. ANTIDO TE | |
101 | ||
102 | 18. STATUS (Check on e) | |
103 | ||
104 | INVESTIGAT IONAL | |
105 | ||
106 | PHASE II | |
107 | ||
108 | COMERCIALL Y AVAILABL E | |
109 | ||
110 | ||
111 | PHASE I | |
112 | ||
113 | PHASE III | |
114 | ||
115 | OTHER (Spe cify) | |
116 | ||
117 | 19. NAMES OF AUTHORI ZED PRESCR IBERS | |
118 | A. | |
119 | B. | |
120 | ||
121 | ||
122 | C. | |
123 | D. | |
124 | ||
125 | ||
126 | 20. SIGNAT URE OF RES PONSIBLE O R PRINCIPA L INVESTIG ATOR | |
127 | DATE | |
128 | 22. PATIEN T IDENTIFI CATION (I. D. place o r give nam e – last, first, mid dle) | |
129 | ||
130 | ||
131 | ||
132 | 21. APPROV ED BY | |
133 | ||
134 | A. SUBCOMM ITTEE ON H UMAN STUDI ES | |
135 | ||
136 | 21A. SIGNA TURE OF CH AIRPERSON | |
137 | DATE | |
138 | ||
139 | ||
140 | ||
141 | ||
142 | B. RESEARC H AND DEVE LOPMENT CO MMITTEE | |
143 | ||
144 | 21B. SIGNA TURE OF CH AIRPERSON | |
145 | DATE | |
146 | ||
147 | ||
148 | ||
149 |
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