REPORTING FORM Clinical investigations: Serious Adverse Event Report Table v2 (MEDDEV 2.7/3) EUDAMED - ID: Title of Clinical Investigation: CIP Number: Contact person (Name, Address, E-Mail, Device type: Telephone Number) MS + NCA Reference Numbers Reference for all Member State: participating countries: No. of patients No. of patients enrolled to No. of Invest. No. of Invest. enrolled to date date (date of report) per Devices used to Devices used to country date date per country Date of Report: dd/mm/yyyy Relationship to Relationship to Treatment Event Status: Date of no Date Sponsor Action / Procedure: not Investigational Device: Arm: Resolved / Event Code Date of Procedure / Date of OR code u received Study code SAE or treatment / related OR unlikely not related OR unlikely Investigational Resolved with First Use Onset Description of event m, ID Report of SAE Center Dev. Def. patient OR possible OR OR possible OR Device / Sequel / yes ID (dd/mm/yyyy) (dd/mm/yyyy) Status: a, (dd/mm/yyyy) outcome probable OR causal probable OR causal Control Group / Ongoing / Country relationship relationship blinded / n.a. Death SAE Unanticipated Patient SADE: Note 1: Submission of this report does not, in itself, represent a conclusion by the sponsor or the competent authority that the content of this report is complete or that the device(s) listed failed in any manner and/or that the device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person. Note 2: If additional columns are added to this form (for instance to include the opinion of the investigators), please add them next to the existing columns on the right. This form may be subjected to automatic analysis and addition of columns in between may interfere with automatic analysis. Widthening of columns can be applied without alteration of the order.
REPORTING FORM Clinical investigations: Serious Adverse Event Report Table v2 (MEDDEV 2.7/3) EUDAMED - ID: Title of Clinical Investigation: CIP Number: Contact person (Name, Address, E-Mail, Telephone Number) Device type: MS + NCA Reference Numbers for all participating countries: Reference Member State: No. of patients enrolled to date No. of patients enrolled to date (date of report) per country No. of Invest. Devices used to date No. of Invest. Devices used to date per country Date of Report: dd/mm/yyyy Status: a, m, u Date Sponsor received Report of SAE (dd/mm/yyyy) Country code Study Center Patient ID Code SAE ID code Date of Procedure / First Use (dd/mm/yyyy) Date of Onset (dd/mm/yyyy) SAE or Dev. Def. Description of event Action / treatment / patient outcome Relationship to Procedure: not related OR unlikely OR possible OR probable OR causal relationship Relationship to Investigational Device: not related OR unlikely OR possible OR probable OR causal relationship Unanticipated SADE: yes OR no Treatment Arm: Investigational Device / Control Group / blinded / n.a. Event Status: Resolved / Resolved with Sequel / Ongoing / Death Date of Event Note 1: Submission of this report does not, in itself, represent a conclusion by the sponsor or the competent authority that the content of this report is complete or that the device(s) listed failed in any manner and/or that the device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person. Note 2: If additional columns are added to this form (for instance to include the opinion of the investigators), please add them next to the existing columns on the right. This form may be subjected to automatic analysis and addition of columns in between may interfere with automatic analysis. Widthening of columns can be applied without alteration of the order.
Clinical%20invest%20SAER_EN.docx