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Administration Comptroller General 1996 Files he96117NIH EXTRAMURAL CLINICAL RESEARCHHealth, Education, and Human Services DivisionResults in BriefBackgroundFigure 1: Number of Extramural Phase III Clinical Trials Sponsored by NIH, Fiscal Year 1994NIH Institutes and Grantees Provide Oversight of Clinical TrialsGrants Management Officers Monitor Fiscal IntegrityProgram Officers and Oversight Boards Monitor Scientific ConductControls That Protect Trial Data Integrity Are Not Always Consistently AppliedBenefits of Data Coordinating Centers' IndependenceCentralized NIH Oversight of andGuidance on Managing Clinical Trials Is LimitedNIH Conducts Limited Central Oversight and Monitoring of Phase III Clinical TrialsNIH Has Not Adopted a Recommendation to Develop Agencywide Guidance on Managing Clinical TrialsConclusionsAgency CommentsContentsAppendix I Scope and MethodologyTable I.1: Four Phase III Clinical Trials ReviewedTable I.1: Four Phase III Clinical Trials Reviewed - ContAppendix II Comments From the Department of Health and Human ServicesAppendix III Major Contributors to This ReportOrdering InformationBLANK PAGEhe96117BLANK PAGEBLANK PAGEAddress Correction Requested
Comptroller General 1996 Files he96117NIH EXTRAMURAL CLINICAL RESEARCHHealth, Education, and Human Services DivisionResults in BriefBackgroundFigure 1: Number of Extramural Phase III Clinical Trials Sponsored by NIH, Fiscal Year 1994NIH Institutes and Grantees Provide Oversight of Clinical TrialsGrants Management Officers Monitor Fiscal IntegrityProgram Officers and Oversight Boards Monitor Scientific ConductControls That Protect Trial Data Integrity Are Not Always Consistently AppliedBenefits of Data Coordinating Centers' IndependenceCentralized NIH Oversight of andGuidance on Managing Clinical Trials Is LimitedNIH Conducts Limited Central Oversight and Monitoring of Phase III Clinical TrialsNIH Has Not Adopted a Recommendation to Develop Agencywide Guidance on Managing Clinical TrialsConclusionsAgency CommentsContentsAppendix I Scope and MethodologyTable I.1: Four Phase III Clinical Trials ReviewedTable I.1: Four Phase III Clinical Trials Reviewed - ContAppendix II Comments From the Department of Health and Human ServicesAppendix III Major Contributors to This ReportOrdering InformationBLANK PAGEhe96117BLANK PAGEBLANK PAGEAddress Correction Requested
Comptroller General 1996 Files
he96117NIH EXTRAMURAL CLINICAL RESEARCHHealth, Education, and Human Services DivisionResults in BriefBackgroundFigure 1: Number of Extramural Phase III Clinical Trials Sponsored by NIH, Fiscal Year 1994NIH Institutes and Grantees Provide Oversight of Clinical TrialsGrants Management Officers Monitor Fiscal IntegrityProgram Officers and Oversight Boards Monitor Scientific ConductControls That Protect Trial Data Integrity Are Not Always Consistently AppliedBenefits of Data Coordinating Centers' IndependenceCentralized NIH Oversight of andGuidance on Managing Clinical Trials Is LimitedNIH Conducts Limited Central Oversight and Monitoring of Phase III Clinical TrialsNIH Has Not Adopted a Recommendation to Develop Agencywide Guidance on Managing Clinical TrialsConclusionsAgency CommentsContentsAppendix I Scope and MethodologyTable I.1: Four Phase III Clinical Trials ReviewedTable I.1: Four Phase III Clinical Trials Reviewed - ContAppendix II Comments From the Department of Health and Human ServicesAppendix III Major Contributors to This ReportOrdering InformationBLANK PAGEhe96117BLANK PAGEBLANK PAGEAddress Correction Requested
NIH EXTRAMURAL CLINICAL RESEARCH
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