1. Liability Insurance for Clinical Trials Single Trial
(questionnaire)
1. Named Insured:
Address:
Telephone:
Fax:
E-Mail:
Date Established:
2. Description of Business:
3. Sponsor:
4. Study Code (protocol’s number):
Protocol Title:
Phase:
5. Hospital(s) and/or institution(s) where the trials are to be performed:
PI Site
6. Number of trial subjects
Worldwide: Brazil:
2. Liability Insurance for Clinical Trials Single Trial
(questionnaire)
7. Trial period:
Worldwide Brazil
Begin: Begin:
End: End:
8. Time of trial per participant (days/weeks/months):
9. Parallel studies in more advanced phases:
10. Serious adverse effects occurred in previous phases:
11. Drug or Procedure to be trial
3. Liability Insurance for Clinical Trials Single Trial
(questionnaire)
12. Insured Limit:
Please attach a copy of:
• PROTOCOL
• PATIENT/VOLUNTEER INFORMATION (If not incorporated in the Protocol)
• PATIENT/VOLUNTEER CONSENT FORM (If not incorporated in the Protocol)