| 1987 - 996 pages
...the Food and Drug Administration at appropriate intervals not exceeding 1 year. Any adverse effects that may reasonably be regarded as caused by, or probably...is contrary to the best Interests of the subjects. h. The Investigator is required to assure the sponsor that for investigations subject to an institutional... | |
| 1981 - 1252 pages
...the Food and Drug Administration at appropriate intervals not exceeding 1 year. Any adverse effects that may reasonably be regarded as caused by, or probably...is contrary to the best interests of the subjects. h. The investigator is required to assure the sponsor that for investigations involving institutionalized... | |
| 1979 - 1056 pages
...drug will not be supplied to any other investigator or to any clinic for administration to subjects. K The Investigator certifies that he will Inform any...is contrary to the best interests of the subjects. h. The investigator is required to assure the sponsor that for investigations Involving institutionalized... | |
| 1978 - 860 pages
...administration to subjects. g. The Investigator certifies that be will Inform any patients or any persons used as controls, or their representatives, that drugs...investigator's professional judgment. Is contrary to the ¿t Interests of the subjects. h. The Investigator is required to assure the sponsor that for investigations... | |
| 1965 - 1520 pages
...any persons used as controls, or their representatives, that drugs are being used for Investlgatlonal purposes, and will obtain the consent of the subjects,...Very truly yours, (Name of Investigator) (Address) (13) The sponsor shall obtain from each investigator involved in clinical trials a signed statement... | |
| 1977 - 1080 pages
...Including subjects used as controls, or their representatives, that drugs are being used for Investigations purposes, and will obtain the consent of the subjects,...Is contrary to the best Interests of the subjects. b. The InvesMgator Is required to assure the sponsor that for Investigations Involving Institutionalized... | |
| United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...administration to subjects. g. The investigator certifies that he will inform any patients or any persons used as controls, or their representatives, that drugs...subjects. Very truly yours, (Name of investigator) TÂddrëssj (13) The sponsor shall obtain from each investigator involved in clinical trials a signed... | |
| 1966 - 2114 pages
...subjects used as controls, or their representatives, that drugs are being used for investlgational purposes, and will obtain the consent of the subjects,...new subjects are added or if significant changes are made in the plan of Investigation.) (1) The label of such drug bears the statement "Caution: New drug—Limited... | |
| United States. Congress. House. Interstate and Foreign Commerce - 1966 - 582 pages
...the following statement : "The investigator certifies that he will inform any patients or any persons used as controls, or their representatives, that drugs...is contrary to the best interests of the subjects." Form FD 1573 contains the same type of certification. INVESTIGATION OF HEW FlGUBE 1. 1 . A STATEMENT... | |
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