Selgitustaotlus

Dear Sir/Madam,

Hope this email finds you well.

Could you please confirm if the provided information (in green color) for medical devices in clinical trials in Estonia is correct?

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

·             Foreign SADEs occurring within study (yes/no)?: Yes.

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

·             SADE Reporting Form: Clinical Investigation Summary Safety Report Form in MDCG 2020-10/2 rev.1.

·             SADE Reporting Method: Please specify the reporting method (eg: email..)

·             SADE Reporting Format: Please specify the reporting Format ( e.g: pdf, excel..)

·             Electronic reporting destination: [email protected]

·             Additional/Exceptions to expedited 7/15 SADE reports? (Yes/No): Yes.

·             if yes, please see special reporting requirements:

- Serious public health threat: 2 days.
- Death or UNANTICIPATED serious deterioration in state of health: 7 days.
- Others: 30 days.

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

• Frequency for Line Listing: NA

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

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

• Periodic Line Listing Format: NA

• Destination for electronic Line Listing: NA

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

• Reporting Timeline for Annual Report (days after DLP): NA.

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

• 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.

• Translation required for safety reports?: NA

• 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

Ruth Jiménez (She/Her)

Submissions Associate,

Patient Safety Solutions (PSS)

Upcoming Out of Office days: 17 and 18 April 2025

E: [email protected]

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