List of content for the Investigator Site File (ISF). Please file applicable trial documents in the appropriate section of the ISF. The templates provided below should be completed and filed in the ISF. Other templates with corresponding information may be used instead.
A CV should be filed in the ISF for everyone at site who has been delegated trial related tasks by the investigator. The CV may be provided in another format or if convenient this template could be used.
A draft PDF version of the electronic CRF dated June 2017, including both the hospitalization and follow-up parts. Login information to the Electronic Data Caputure system will be provided to all users before study start.
English translation of the ethical approval issued by the Regional Ethical Board in Lund, Sweden. (Nr. 2015/228 and 2017/36)
For sites who are interested in the TTM2-trial we would like to request that they fill out this official application form. The information in the form will be used by the steering group when approving sites. It is also very helpful to us have updated contact information for all investigators and research nurses. If you have not previously been in contact with either the coordinating team or a national investigator please send us a short email as well after filling out the form.