Research
Information for researchers
Setting up a research study
Conducting your study
Data collection, analysis and dissemination
Progress reports and study closure
Research Passport
Site file

A to Z of UHSFT

 
Go to the Southampton Hospital Charity pages|

Site file

In order to comply with Good Clinical Practice and the Medicines for Human Use (Clinical Trial) Regulations as amended, all essential documents relating to a study must be retained in an investigator site file (ISF).  More than one file may be used but there must be clear sign-posts within the files that explain the filing system used and to allow documents to be traced.

There are three ISF templates:

ISF template ISF guidance sheets

CTIMP studies| 

Requires update - use only contact page and index for contents of Investigator Site File

Guidance on CTIMP ISF|

Medical device studies| 

Requires update - use only contact page and index for contents of Investigator Site File

Guidance on medical device studies|

Non IMP/device studies|

Requires update - use only contact page and index for contents of Investigator Site File

Guidance on non IMP/device studies|

Quality assurance templates|

Templates for recruitment log, file note, staff delegation log, annual tasks log, training log etc


The R&D department encourages researchers to use these templates and amend them (insert or delete columns/rows, change headers etc) to suit the needs of the specific study. However, it is acceptable to use a different format provided it meets the required standards. Please seek advice from the R&D office| if you plan to use an alternative format.