Bioequivalence and Bioavailability Forum

❝ Who should fill the volunteer registration form-Clinical staff or the volunteer himself? Should the form be filled in the local regional language if the volunteer has to understand what is filled in the form or is it not necessary/requirement?

There are two major forms to be filled and understood.
1- Informed consent form.
2- Case report form.
both I suggest is to be controlled by the clinical staff, to facilitate the work after words, and to be in consestent for all study reports.

thus ICF should be written in the language that is most understandable by the participant, your staff should give the max. contribution to read and explain each and every point mentioned so the participant shouldnt mis-understand any point afterwords.

regards...