Study Site File

Exemplar Investigator Site File for non-statutory sites information (non-medicinal products)

  • A site file demonstrates excellent practice in the life of any study and provides an overview of management over the lifetime of a trial.
  • The file provides a full audit trail of the study over its lifetime and it is the responsibility of the PI (or a delegated individual) to ensure the file is kept updated with the latest documentation where required.
  • If a study is monitored by the study coordinating centre or external regulatory body, an audit of the site file will be carried out.
  • Modification of study documentation is a common occurrence in research and it is essential that samples of all current headed master copies are kept in the investigator site file. When an updated version of essential study documents are received both ethical and local (R&D) approval must have been gained before implementation.
  • Version control is crucial and historical copies must also be kept and clearly marked as superseded so that they are not used in error.
  • The site file should include all study documentation and correspondence generated throughout the duration of a study and should provide someone who has not been involved in the study with a clear picture of the research related activities that have taken place.
  • Each study will have an individual site file and these need to be kept at the site where the patients are being recruited; if this is within the community it should be kept in the main office and also in a locked, fireproof location.
  • All study site files are to be kept for a minimum of five years, maximum of fifteen years however this should be clarified with the study Sponsor within the initiation phase of the study.
  • In IMP studies it is also required for the site file to comply with Good Clinical Practice and Medicines for Human Use (Clinical Trials) Regulations.

Remember – if it is not on paper it did not happen!!