Support for investigator-initiated clinical research involving investigational drugs or devices: The clinical and translational science award experience

Academic Medicine

Volumn 86, Issue 2, 2011, Pages 217-223

  Berro, Marlene ^a,f   Burnett, Bruce K ^b   Fromell, Gregg J ^c   Hartman, Karen A ^d   Rubinstein, Eric P ^e   Schuff, Kathryn G ^f   Speicher, Lisa A ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d MAYO CLINIC   (United States)

^e UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79951676862     PISSN: 10402446     EISSN: None     Source Type: Journal    
DOI: 10.1097/ACM.0b013e3182045059     Document Type: Article

References (10)

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2. Food and Drug Administration. CFR-Code of Federal Regulations Title 21 Part 312: Investigational New Drug Application. https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart-312. Accessed September 3, 2010.
3. Food and Drug Administration. CFR-Code of Federal Regulations Title 21 Part 812: Investigational Device Exemptions. https:// www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart-812. Accessed September 3, 2010.
4. National Institutes of Health. NIH Roadmap for Medical Research. http://nihroadmap.nih.gov. Accessed September 3, 2010.
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6. Heller C, de Melo-Martin I. Clinical and Translational Science Awards: Can they increase the efficiency and speed of clinical and translational research? Acad Med. 2009;84:424-432. http://journals.lww.com/academicmedicine/ Fulltext/2009/04000/Clinical-and-Translational-Science-Awards-Can.11.aspx. Accessed October 10, 2010.
7. Food and Drug Administration. Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer. http:// www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/UCM071717.pdf. Accessed September 3, 2010.
8. Food and Drug Administration. Guidance for Industry: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND. http:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM229175.pdf. Accessed December 22, 2010.
9. Arbit H, Paller MS. A program to provide regulatory support for investigator-initiated clinical research. Acad Med. 2006;81:146-153. http://journals.lww.com/academicmedicine/ Fulltext/2006/02000/A-Program-to- Provide-Regulatory-Support-for.7.aspx. Accessed October 10, 2010. (Pubitemid 44356692)
10. IND/IDE Taskforce, Clinical and Translational Science Award Consortium. CTSA Regulatory Resources. https:// www.ctnbestpractices.org/collaborations/ ctsa-regulatory-resources. Accessed December 7, 2010.