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Clinical Trials Toolkit for Researchers

Booklet:  Children in Research (from Children's Hospital Boston)

Component Analysis of Risks and Benefits in Clinical Trials

Expanded Access to Investigational Drugs outside Clinical Trials

FDA Guidance for Industry:  Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects

Flowchart:  Obtaining Human Research Data UnderHIPAA

HIPAA and Human Subjects Research conducted under the UNR Humans Subjects Protection Program

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

Readability of Consent Form Templates: A Second Look

Shipping Blood and Other Human Materials

UNR Clinical Trials Process Flow

UNR Sponsored Projects Clinical Trials Website

US FDA Guidance on Clinical Trials and Expanded Access for IRBs, Researchers, Sponsors

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