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For trials conducted in Australia, the TGA requires that Essential Documents for a clinical trials are kept for a minimum of 15 years after the completion of the study.  It is impractical to retain records in the research clinic for such a length of time and, therefore, most studies are archived either in a storage facility on site or through a document storage company.  When archiving a study, there are a number of important things to consider:

  • Confidential information is stored in accordance with the Privacy Act and your Institution’s Privacy Policy.  I recommend that any information containing a participant’s name, address or contact details be stored separately from information that is coded or deidentified.  This is particularly important when the Sponsor takes responsibility for archiving the study.
  • Records are stored in a manner that they will still be interpretable in 15 years.
    • This means removing all metal (paper clips, staples) and plastic (sheet protectors, binders, section dividers) that may degrade the paper or typeface.
    • Photocopying any items printed on thermal paper such as ECG printouts, faxes or receipts.
    • Digitally archived material is stored with a device to read the information.
    • Email correspondence is printed in full and included in the communication section.
  • A record is kept at site about where the study is archived and when it can be destroyed.  I recommend an archiving file containing the Sponsor, Protocol Number, Study title, date of archiving, number of boxes and destruction date for each study archived.  An itemised list of what is in each box is helpful if you have to find information at a later date (which happens more often than you would think).
  • Shred anything that is not required to be archived.
  • There is a copy of any electronic records such as eDiaries or eCRFs on file.  If a copy is not archived with the site files, a File Note should be added stating the location (eg archived by the Sponsor).

archiving

 

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