title: Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research.
abstract: In response to concerns about interactions of academic and public health investigators with industry, the Canadian Association for Immunization Research and Evaluation (CAIRE), in collaboration with six major vaccine manufacturers, developed guidelines for participation in industry-sponsored clinical trial and epidemiology contract research within Canada. Topics addressed include definition of investigators, data ownership, protocol development, data management, data analysis, producing a study report and publication of the results of the study.
authors.affiliation: CAIRE Research Sponsor Advisory Board, Halifax, Nova Scotia. scott.halperin@dal.ca
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: David
authors.initials: D
authors.lastname: Scheifele
authors.forename: Bernard
authors.initials: B
authors.lastname: Duval
authors.forename: Barbara
authors.initials: B
authors.lastname: Law
authors.forename: Brian
authors.initials: B
authors.lastname: Ward
authors.forename: Gordean
authors.initials: G
authors.lastname: Bjornson
authors.forename: Beth
authors.initials: B
authors.lastname: Halperin
authors.forename: Danuta
authors.initials: D
authors.lastname: Skowronski
authors.forename: Arlene
authors.initials: A
authors.lastname: King
authors.forename: Greg
authors.initials: G
authors.lastname: Hammond
authors.forename: Simon
authors.initials: S
authors.lastname: Dobson
authors.forename: Susan
authors.initials: S
authors.lastname: Tamblyn
authors.forename: Elaine
authors.initials: E
authors.lastname: Wang
authors.forename: Pierre
authors.initials: P
authors.lastname: Lavigne
authors.forename: Lisa
authors.initials: L
authors.lastname: Danzig
authors.forename: Donald
authors.initials: D
authors.lastname: Elrick
authors.forename: Elspeth
authors.initials: E
authors.lastname: Carnan
authors.forename: James
authors.initials: J
authors.lastname: Mansi
authors.forename: Francoise
authors.initials: F
authors.lastname: Bertrand
authors.forename: Laszlo
authors.initials: L
authors.lastname: Palkonyay
authors.forename: Gail
authors.initials: G
authors.lastname: Clements
authors.forename: Neil
authors.initials: N
authors.lastname: Maresky
authors.forename: David
authors.initials: D
authors.lastname: Wortzman
mesh_terms: D002170:Canada; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000592:standards*; D003627:Data Interpretation, Statistical; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D007114:Immunization / Q000592:standards*; D011642:Publications; D012106:Research / Q000592:standards*; D009626:Terminology as Topic