Example 1 of 4
Your clinical trial information will be recorded on forms and sent to the
clinical trial sponsor, which is _________________. The California State
University, Los Angles Institutional Review Board and governmental regulatory agencies
(such as the Food and Drug Administration) may need to look at your
medical records to verify the forms. By signing this form, you or your
legally authorized representative is authorizing such access. Your name
will not appear in any report or publication.
Example 2 of 4
The records of this study will be kept private. In any sort of report we
might publish, we will not include any information that will make it
possible to identify a subject. Your record for the study may, however,
be reviewed by the drug manufacturer, by representatives of the Food and
Drug Administration, by NIAID, and by study monitors. To that extent,
confidentiality isn't absolute.
Example 3 of 4
The records of this study will be kept private. Since questionnaires will ask only for gender and age, it has been made impossible to identify
subjects by name. Consent forms will be kept securely along with results
for three years after completion of this study.
Example 4 of 4
Study involving investigational drug:
Because this study involves an investigational drug regulated by the Food
and Drug Administration, the agency may choose to look at records that
identify you as a participant in this research project. Your records may
also be inspected by the sponsor, __________, Inc. By signing this
document you consent to such an inspection.