Reportingrelated to a Clinical Trial

VO-Form

ReportingRelated to a Clinical Trial

Swissmedic
Please leave this section blankfor Swissmedic:
Received by Swissmedic on / Reviewed by:
For internal use only / Date:
For internal use only
For further instructions on the use of this form, please read the information providedon our web page trialsin the “Guidelines for submission of changes” and the”Instruction for the notification of safety measures and SUSARs in clinical trials”.
This part must be completed by the applicant:
Purpose of submission:Please tick a box
☐Submission ofone or several documentsconcerningmore than one trial(e.g. DSUR)
Caution:A separate form must be used for each Swiss representative!
☐Submission ofone or several documents concerning a single trial

Please enter the Swissmedic reference number of the clinical trial (e.g. 20XXDRXXXX, see Swissmedic authorization) and the sponsor trial code.
If several trials are concerned, provide the reference numbers ofall trialson separate lines.

Swissmedic reference number / Sponsor trial code

Informationregarding the submission: Please enter text

RE:
Rationale/information:

Please enter the title, version and date of the submitted document(s). Write “NA” for empty sections.
Each document has to be entered on a separate line

Topic
/ Document title and version
(e.g. Final study report Version 1.2. ) / Document date
R1:Information letters e.g. DHPL, DIL
R2: Notification of safety and protective measures (KlinV art. 37 para. 3)
R3: Annual safety reports* (KlinV art. 43 para. 3) (e.g. DSUR)
R4: Interruption of a clinical trial (KlinV art. 38 para. 2)
R5: Discontinuation of a clinical trial** (KlinV art. 38 para. 2)
R6: Completion of a clinical trial** (KlinV art. 38 para. 1)
R7: Final Clinical Study Report (KlinV art. 38 para. 3)
*Complete also section 4 of this form
**Complete also section 5 of this form

Mandatoryadditional information regarding the submission of an annual safety report (i.e. DSUR)
Tobe completed onlyif an annual safety report is submitted

NewSUSAR(s) in Switzerland during reporting period / Number of SUSAR(s)
List of SUSARs
Write for each new SUSAR
Each SUSAR has to be entered on a separate line / Swissmedic
U-number / Swissmedic reference number / Date of initialreporting
SUSAR
Risk/Benefit-Statement:

Mandatory information regarding the completion of a clinical trial (KlinV Art. 38)
Tobe completed only if a trial end is reported

The trial concerned is a:
a)National trial
☐end of trial in Switzerland Date ***:
b)International trial
☐end of trial in Switzerland Date ***:
☐global end of trialDate ***:
***usually LPLV (Last Patient Last Visit); if other, comment in section 2 of this form

Applicant’s Confirmation
Completion of this section is mandatory.

/ I hereby confirm that all the information provided in this form is correct and that the application documents submitted in paper and in electronic format (CD) are the same.
Swiss sponsor or Sponsor representative in Switzerland
(contact for Swissmedic correspondence)
Company / institution:
Contact person:
Address (in CH):
Phone:
E-mail:
Applicant
(if different from above mentioned representative in Switzerland)
Company / institution:
Contact person:
Address:
Phone:
E-mail:
Date:Signature:

Fees:Evaluation of amendments and other submissions will be invoiced with CHF200/hour if amount of work is more than ½ hour, and will be charged once the submission has been processed(Art.34, Ordinance on fees levied by the Swiss Agency for Therapeutic Products).

QM-Ident: BW101_10_005e_FO / V02 / gav / jaf /05.05.20171 / 3

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