CTA – Clinical Trial Appplication (Annex 1)
DB – Data Box (for subjects from Czech Republic only)
e-mail – posta@suklcz 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@suklcz or surface mail on CD) |
|
2 |
CTA update with change of Sponsor, change of Legal Representative or change of Contact Person |
xml electronically (DB, e-mail to address: posta@suklcz or surface mail on CD) but CTA in hardcopy via surface mail (original of signature page is required) |
|
3 |
Form for application related to covering expenditures for expert activities conducted upon request |
Elektronically (DB, e-mail to address: posta@suklcz) |
|
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 |
|
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@suklcz |
|
7 |
Actualization of the Informed Consent Form |
As with item 5, additionally can also be sent by e-mail to address: posta@suklcz (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@suklcz |
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@suklcz |
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@suklcz |
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@suklcz |
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@suklcz |
|
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@suklcz; printed format of DSUR is not required, electronic format (eg. pdf) must be in the searchable format |
|
14 |
Information about the CT suspension |
As with item 5, additionally can also be sent by e-mail to address: posta@suklcz |
|
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@suklcz |
|
17 |
„Urgent Safety Restrictions“ |
Immediately by phone or e-mail to address: posta@suklcz, 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) |
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* 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)