Trial mobile version Guidances- combined files 6_27_14 - page 12

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INSTITUTIONAL REVIEW BOARD
 Guidance on IRB Continuing Review of Research (2010)
Created by the Department of Health and Human Service, Office for Human Research Protections
(OHRP), this resource provides Institutional Review Boards with information to assist them in the
‘continuing review’ process. Included are:
 Key Points for the Process of Conducting Continuing Review
 Items to Consider in the evaluation of a research study
 Consideration for the review of Multicenter Research Projects
 Investigational New Drug Applications (INDs) – Determining Whether Human Research
Studies Can Be Conducted without an IND
This guidance was designed for research investigators, sponsors and IRBs. It explains when an
U.S. Food and Drug Administration (FDA) ‘Investigational New Drug Application’ (IND) is
necessary for a research study. It includes the following useful information:
 The definition of ‘drug’ according to the FDA
 Examples of clinical investigations that require the use of an IND
 Criteria for Exemption from IND application
 IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research
Sites, and the Determination of whether an Investigational New Drug Application(IND) or
Device Exemption (IDE) is Needed
Created by the Food and Drug Administration (FDA), this resource provides tips for Institutional
Review Board (IRB) review of research studies involving drugs or experimental medical devices. It
includes:
 Tips for IRB inspection of a research site
 Tools for IRB evaluation of investigator qualifications.
 Guidance for IRB verification of whether an IND is required for a study