Vastuskiri

Dear Aleksandra Chevalier,

Please note, that we have already replied to identical questionnaire from you in August 2023 (please find letter attached). Since that time nothing has changed in requirements.

Dear Sir/Madam,

Hope this email finds you well.

Could you please confirm if the provided information (in green color) for Medical device clinical trials in Estonia is correct.

·         Domestic USADEs occurring within study (yes/no)? Yes

·         Foreign USADEs occurring within study (yes/no)? Yes

·         USADEs from other studies with same study device  / Cross-reports (yes/no)? No

o   USADE Reporting Form: Clinical Investigation Summary Safety Report Form

o   USADE Reporting Method: Electronic

o   USADE Reporting Format: Electronic

             Electronic reporting destination: mso@terviseamet.ee

·         Additional/Exceptions to expedited 7/15 USADE reports? (Yes/No) if yes, please see special reporting requirements: Yes - Serious public health threat: 2 days. Death or UNANTICIPATED serious deterioration in state of health: 10 days. Others: 30 days

·         Periodic Line Listing required? (Yes/no) if yes, please confirm: No

o   Frequency for Line Listing: NA

o   Reporting Timeline for Periodic Line Listing (days after DLP) NA

o   Periodic Line Listing Reporting Method (e.g. e-mail, N/A, etc.) NA

o   Periodic Line Listing Format: NA

Destination for electronic Line Listing: NA

·         Annual Report required? (yes/no) if yes, please confirm: No

o   Reporting Timeline for Annual Report (days after DLP) NA

o   Annual Report Reporting Method (e.g. courier, CESP, email etc) NA

o   Annual Report Reporting Format (e.g. paper, CD-ROM, pdf, eCTD etc) NA

Destination for electronic Annual Report submission: NA

• Periodic Report Special reporting requirements: NA

o   Translation required for safety reports? No

o   Translation requirements - Language and report/information to be translated? (if yes, please specify the language) NA

Thank you in advance for your time and collaboration

Best Regards,

Aleksandra Chevalier, MPharm

Drug Safety Associate, Drug Safety

E: aleksandra.chevalier@fortrea.com
fortrea.com
Fortrea Development Ltd 

Fortrea
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