Data on File Development and Maintenance

The term Data on File (DOF) is used to describe or classify any data that is available internally but not published in the public domain. It is often a company’s proprietary information and generally considered to be sensitive and confidential. Therefore, use of this type of data requires separate review and approval.

Why is Data on File used?

Data on file is generally used in a document, and referenced as such, when data needed to support a message, claim, or endpoint has not been published. Companies may also use DOF in internal documents such as a Clinical Study Report (CSR) or Integrated Summary of Safety (ISS), which are not publicly available. Prior to use, a DOF document needs to be created, reviewed, and approved.

How can Med Communications help?

Med Communications has extensive experience developing DOF documents. Our highly skilled medical writers have an in-depth understanding of when and how DOF documents can and should be used. At Med Communications, we understand the importance of having DOF documents developed in an accurate and timely fashion, while also ensuring the documents are reviewed and maintained for continued use.

If you need skilled professionals to help with your company’s DOF process, we will partner with you to develop, review, organize, and maintain your DOF documents.