title: Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial.
abstract: BACKGROUND
  Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial.
  
  
  OBJECTIVE
  To review and analyze the large volume of AE data reported by 10 sites (806 SAEs and 19,034 AEs from August 2000 to May 2007) the automated SAE summary was developed. It was designed to ensure timeliness and clarity in the complex process of AE review and reporting.
  
  
  METHODS
  The AE and SAE case report forms (CRFs) as well as the automated SAE summary were developed within a database management system developed by the Data Coordinating Center (DCC) which allowed for web-based data entry at the DCC and 10 sites and offered immediate overall and site-specific reports accessible by the DCC, site, and NIH project staff.
  
  
  RESULTS
  The automated SAE summary pulled data from multiple CRFs to create a succinct and informative summary and allowed for prompt and easy reporting to the regulatory agencies. The summary was adaptable to the needs of reviewers because of the availability of multiple search options.
authors.affiliation: New England Research Institutes, Watertown, MA 02472, USA. mbell@neriscience.com
authors.forename: Margaret C
authors.initials: MC
authors.lastname: Bell
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Robuck
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Wright
authors.forename: Marina S
authors.initials: MS
authors.lastname: Mihova
authors.forename: Charlotte
authors.initials: C
authors.lastname: Hofmann
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: De Santo
authors.forename: Susan L
authors.initials: SL
authors.lastname: Milstein
authors.forename: Pamela A
authors.initials: PA
authors.lastname: Richtmyer
authors.forename: Janel L
authors.initials: JL
authors.lastname: Shelton
authors.forename: Maureen
authors.initials: M
authors.lastname: Cormier
authors.forename: Debra L
authors.initials: DL
authors.lastname: King
authors.forename: Choon J
authors.initials: CJ
authors.lastname: Park
authors.forename: Wallis A
authors.initials: WA
authors.lastname: Molchen
authors.forename: Yoon
authors.initials: Y
authors.lastname: Park
authors.forename: Michelle
authors.initials: M
authors.lastname: Kelley
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000517:prevention & control; D003628:Database Management Systems; D018450:Disease Progression; D001330:Electronic Data Processing / Q000379:methods*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000209:etiology / Q000517:prevention & control; D017093:Liver Failure / Q000209:etiology / Q000517:prevention & control; D008113:Liver Neoplasms / Q000209:etiology / Q000517:prevention & control; D015337:Multicenter Studies as Topic / Q000379:methods; D009316:National Institutes of Health (U.S.); D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011994:Recombinant Proteins; D012107:Research Design; D014481:United States
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a