Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial

Clinical trial sponsors are kindly requested to send amendments to the protocol and updates to an approved/authorised clinical trial dossier in electronic format only.  

SÚKL hereby kindly requests that the sponsors of clinical trials (hereinafter referred to as “CT”) submit updated documentation for the CT following the issuance of  authorisation/approval of the conduct of the CT solely in electronic format, i.e. either by sending it to the data mailbox or, where large volumes of data are concerned, through the CESP (exceptionally by Eudralink to the address of the clinical assessor) or to the Institute’s electronic mail room (i.e. posta@sukl_cz, signed with a certified electronic signature); the printed version of the documents is no longer to be submitted.

In case of updates to the CTA form, the sponsor shall send the updated application in the xml format, pdf format, and a scan of the signature page.

In case of a change to a power of attorney concerning an indefinite number or procedures regarding a certain subject-matter (as referred to under Section 33, paragraph 2(c) of Act No 500/2004 Coll., the Administrative Code) is concerned, it is also necessary to submit the original, i.e. the printed form thereof; in other cases, scans of powers of attorney shall be sufficient.

 

14 December 2017

Department of Clinical Trials