Ways of submission of additional documents during Clinical Trial

State Institute for Drug Control, Clinical Trials Department informs about ways of submission of additional documents during Clinical Trial of human medicinal products.  

CTA – Clinical Trial Appplication (Annex 1)

DB – Data Box (for subjects from Czech Republic only)

e-mail – posta@sukl_cz or (always with identification of the Clinical Trial by EudraCT number and SÚKL identification number)

IB – Investigator`s Brochure

IMPD – Investigational Medicinal Product Dossier

  

document                                        

way of submission                      

link to closer specification of submitted document                      

1

CTA update (excluding change of Sponsor, change of Legal Representative or change of Contact Person)

elektronically pdf + xml (DB, e-mail to address: posta@sukl_cz or surface mail on CD)

https://eudract.ema.europa.eu/

2

CTA update with change of Sponsor, change of Legal Representative or change of Contact Person

xml electronically (DB, e-mail to address: posta@sukl_cz or surface mail on CD) but CTA in hardcopy via surface mail (original of signature page is required)

https://eudract.ema.europa.eu/

3

Form for application related to covering expenditures for expert activities conducted upon request

Elektronically (DB, e-mail to address: posta@sukl_cz

http://www.sukl.eu/modules/payment2/

4

new Power of Attorney and Letter of Authorisation

with original signatures via surface mail 

further details are described in guideline  KLH-20, Annex No. 3 – Guidance on Power of Attorney and No. 4 - Power of Attorney / Letter of Authorisation templates

5

Substantial Amendment to Protocol, IB and IMPD

Documents via DB(scanned cover letter + Amendment Notification Form; electronical documentation*) or via surface mail (original of cover letter + signed Amendment Notification Form; rest of documentation on CD*, hardcopies of documents (protocol, protocol amendment, IB and IMPD) are not required

Amendment Notification Form

6

Non-substantial amendment to the Protocol, IB** and IMPD   

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

 

7

Actualization of the Informed Consent Form 

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz (scan cover letter and ICF in the clean version, the hightlighted and tracked changes version) 

 

8

Progress Report 

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

Progress Report: Annex  6 of the Decree  No 226/2008 Coll.

9

End of Trial Report

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

Final Report: Annex 8 of the Decree  No 226/2008 Coll.

10

Information about the commencement of the CT in the Czech Republic (in compliance with Section 15 paragraph (1) of the Decree  No 226/2008 Coll.)

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

Information about the commencement of the CT in the Czech Republic: Section 15 paragraph (1) of the Decree  No 226/2008 Coll.

11

Information about the end of the CT in the Czech Republic (in compliance with Section 56 paragraph (5) of the Act No 378/2007 Coll.)   

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

Information about the end of the CT in the Czech Republic: Section 56, paragraph (5) of the Act No 378/2007 Coll.

12

Global end of the CT (submission of the End of Trial Notification Form) 

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

 End of Trial Notification Form

13

DSUR (development safety update report), substitutes submission of an annual safety report in compliance with Section 58 paragraph (8) of the Act No 378/2007 Coll. containing information specified in Annex 7 of the Decree  No 226/2008 Coll.

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz; printed format of DSUR is not required, electronic format (eg. pdf) must be in the searchable format  

ICH guideline E2F on development safety update report  

14

Information about the CT suspension 

As with item 5, additionally can also be sent by e-mail to address: posta@sukl_cz

 

15

„Dear Investigator Letter” 

According to the item 5 or 6 – depending on whether it is presented  as a substantial amendment (item 5) or non-substantial amendment (item 6) 

 

16

Ethics Committee Opinion

As with item 5, additionally can also be sent by e-mail to address eticka.komise@sukl_cz

 

17

„Urgent Safety Restrictions“  

Immediately by phone or e-mail to address: posta@sukl_cz, subsequent completion of documentation  after communication with SÚKL (According to item 5 or 6 - depending on whether it will be dealt with as a substantial amendment  (item 5) or non-substantial amendment (item 6)

 

* Documents in the electronical format: IB, IMPD  (eventually protocol) in the electronical format  – e.g. structured pdf (format,  which is  text-searchable, not the scan of paper documentation).

** IB including annual IB actualization, if not a substantial amendment  

Note:

  • When sending e-mails, in the subject always quote the SUKL identification sign and EudraCT number.
  • When sending e-mails, it is not considered to be secure data sending, it is recommended sending secure e-mail (e.g. EudraLink).
  • When sending large documents it is preferable to send a CD by mail or Eudralink or CESP. 

 

Department of Clinical Trials and Unregistered Medicines

 2nd November 2018 (update)