title: Preserving participant anonymity during remote preenrollment consent form checking.
abstract: BACKGROUND
  In biomedical research, the consent form must comply with regulatory requirements. Checking for compliance typically has been performed on-site and most frequently after a participant's final enrollment. We use a procedure for remote preenrollment checking of consent forms that protects participant identities. This procedure requires a copy of the consent form that partially masks the fields for participant's name and signature; this copy is faxed to the clinical trials unit for checking.
  
  
  OBJECTIVE
  To describe our efforts to identify an appropriate printed masking pattern. We tried several patterns that permit ascertainment of the presence of signatures and names and evaluated each one with respect to degree of masking participant identities.
  
  
  METHODS
  We assessed the efficiency of a satisfactory pattern through an experiment. We created forms with variants of the masking pattern on the copy to be faxed. We completed the forms with fictitious identities before copies were faxed and checked by clinical research associates. We measured the rate of empty and filled fields detected and the rate of letters and names correctly read. The target was defined as 100% for the rate of empty and filled fields detected and 0% for the rate of letters and names correctly read.
  
  
  RESULTS
  The best masking pattern allowed the detection of 100% empty and filled fields and the reading of 0% names and 19% letters. Consequently, the consent form with the selected masking pattern has been used routinely in our clinical trials unit.
  
  
  CONCLUSIONS
  We tested only five fictitious identities, five individuals who completed forms, and three who checked forms. Also, we initially considered only four patterns and variations in them.
  
  
  CONCLUSIONS
  We defined a masking pattern that satisfactorily fulfilled our needs for confidentiality. This and other procedures for remote preenrollment checking of consent form can be a key component of a risk-based monitoring strategy.
authors.affiliation: INSERM, CIC-EC7, Bordeaux, France. valerie.journot@inserm.fr
authors.forename: Valérie
authors.initials: V
authors.lastname: Journot
authors.forename: Sophie
authors.initials: S
authors.lastname: Pérusat-Villetorte
authors.forename: Caroline
authors.initials: C
authors.lastname: Bouyssou
authors.forename: Sandrine
authors.initials: S
authors.lastname: Couffin-Cadiergues
authors.forename: Aminata
authors.initials: A
authors.lastname: Tall
authors.forename: Catherine
authors.initials: C
authors.lastname: Fagard
authors.forename: Geneviève
authors.initials: G
authors.lastname: Chêne
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D003219:Confidentiality / Q000331:legislation & jurisprudence; D032962:Consent Forms / Q000458:organization & administration*; D003625:Data Collection / Q000331:legislation & jurisprudence / Q000379:methods*; D005568:Forms and Records Control / Q000379:methods*; D005602:France; D033161:Government Regulation; D006801:Humans; D035842:Research Subjects / Q000331:legislation & jurisprudence*