Ethical issues, safety, and data integrity in clinical trials

Inflammatory Bowel Diseases

Volumn 11, Issue SUPPL. 1, 2005, Pages

  Tremaine, William J ^a   Carlson, Marilyn R ^b   Isaacs, Kim L ^c   Motil, Kathleen J ^d   Robuck, Patricia R ^e   Wurzelmann, John I ^f   Merrick, Marjorie ^g  

^a Mayo Clinic   (United States)

^b entreMeDica Inc   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^f GLAXOSMITHKLINE   (United States)

^g Crohn's and Colitis Foundation of America   (United States)

Author keywords

Adverse event; Covered entities; Data Safety and Monitoring Board; Equipoise; Good Clinical Practice; Health Insurance Portability and Accountability Act; Informed consent; Institutional review board; Privacy Rule; Protected health information

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; GOOD CLINICAL PRACTICE; HEALTH CARE ORGANIZATION; INFORMED CONSENT; LAW; MEDICAL ETHICS; PRIORITY JOURNAL; RISK ASSESSMENT; SAFETY;

CLINICAL TRIALS; CONFIDENTIALITY; CONFLICT OF INTEREST; ETHICS, MEDICAL; GUIDELINE ADHERENCE; HUMANS; INFORMED CONSENT; QUALITY CONTROL; SAFETY;

EID: 27644437677     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/01.MIB.0000184850.46440.ea     Document Type: Article

References (3)

1. Brown, Stephen R. Scurvy: How a surgeon, a mariner, and a gentleman solved the greatest mystery of the age of sail. St. Martin's Press: New York, NY; 2003.
2. Jensen, Erich. Read the SMALL PRINT of the 1572. Presentation at the University of Michigan Center for the Advancement of Clinical Research, Ann Arbor, Michigan. October 20, 2003; www.wlap.org/wl-repository/umich/cacr/cre/ 20031020/real/f001.htm
3. International Conference on Harmonisation (ICH) Guideline for Industry Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, March 1995 and 21CRF312 Investigational New Drug application (IND) [FDA IND Regulations]; http://www.fda.gov/cder/guidance/959fhl.pdf