Research Records

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Maintain human research records, including signed and dated consent documents for at least three years after completion of the research. Maintain signed and dated HIPAA authorizations and consent documents that include HIPAA authorizations for at least six years after completion of the research. If the human research is sponsored contact the sponsor before disposing of human research records.

Confidentiality and Document Storage

If a master code list is being kept for confidentiality, do not link private identifiable information to data by others means.

  • Do not put study ID numbers on signed consent forms.
  • Do no put names on data collection forms.
  • Do not store signed consent forms – or any other forms with identifiable information – with data collection forms.
  • Do not store the linking list with de-identified data.

 

See also