Archive a project

The guidelines address the need to:

• Maintain full study records for a sufficient time to resolve scientific queries and challenges that may arise after completion of the study
• Ensure that study records are disposed of carefully or in a fashion that will not compromise the privacy of study participants and confidentiality of the study data.

Archiving instructions

Ensure the preliminary procedures found in the Archiving guideline have been done:

• Place all documents in heavy-duty archive boxes. 
• Complete the Archive Record. The list of documents for archiving can be amended to suit the study. The glossary explains terms found on the Archive Record.
• Pack archive boxes so that participant documentation is not divided between boxes. Should this occur, record the details on the Archive Record.
• To protect participant confidentiality store identifiable information such as signed consent forms separately from CRFs and any document linking identifiable participant information to study numbers.
• Electronic data can be stored in the same boxes as paper documents. Boxes containing electronic media must be identified in the table labelled Electronic Media on the last page of the Archive Record.
• Number the boxes to match the details on the Archive Record.
• Boxes must not be overfilled nor weigh more than 16kg.
• Email the completed Archive Record to the Office of Ethics and Research Governance for processing.
• A reply with label (s) attached will be emailed. The barcode(s) will be sent via internal mail or collection can be arranged.
• Attach the barcode(s) to the front of each box.
• Complete the Archiving Box labels for each box and attach next to the barcode.
• The Archive Record should be securely filed in the department responsible for the study, for example in a folder labelled “Record of Archived Materials”. This can be used to identify specific boxes that may need to be accessed in the future. The Office of Ethics and Research Governance will also retain the Archive Record with the master project file.
• Ensure lids fit properly and are secured to the box with strong tape.
• Collection can be arranged via the Office of Ethics and Research Governance.  If  a number of projects are going to be archived, wait until all boxes are ready to be sent off-site in one collection
• To arrange collection and for inquiries contact 9076 3619 or email research@alfred.org.au.