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" An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: ( 1 ) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Side 228
1999
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 596 sider
...1221e-3, 3474; and 42 USC 300v-l(b)) §97.115 1KB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation...show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining;...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001 - 964 sider
...avoiding1 duplication of effort. S 746.1 15 IRB record*. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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The Code of Federal Regulations of the United States of America

1985 - 472 sider
...avoidance of duplication of effort. §46.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation...investigators, and reports of injuries to subjects. 'Reports should be filed with the Office for Protection from Research Risks, National Institutes of...
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The Code of Federal Regulations of the United States of America

1995 - 712 sider
...records. (a) An institution, or when appropriate an IRB, shall prepare and main§11.111 §11.116 tain adequate documentation of IRB activities, including...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001 - 780 sider
...An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of TUB activities, including the following: (1) Copies of...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 760 sider
...An Institution, or when appropriate an IRB. shall prepare and maintain adequate documentation of IRK activities, including the following: (1) Copies of...and reports of Injuries to subjects. (2) Minutes of ШВ meetings which shall be In sufficient- detail to show attendance at the meetings; actions taken...
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The Code of Federal Regulations of the United States of America

1998 - 668 sider
...avoiding duplication of effort. 946.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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The Use of Human Biological Materials in the Development of Biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 312 sider
...avoidance of duplication of effort 146.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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Ethics and Regulation of Clinical Research

Robert J. Levine - 1988 - 484 sider
...Subpart D — Records and Reports §56.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1989 - 464 sider
...Subpart D — Records and Reparts § 56.115 IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation...and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken...
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