Submission of Clinical Trial Applications

As of 31 January 2023, clinical trial sponsors must enter all new clinical trial applications into the Clinical Trials Information System (CTIS) pursuant to Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use.

Submissions Must Be Made in Electronic Form via CESP in Accordance with GCP-V

In some cases, ongoing clinical trials are still running under the provisions of the Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for use in humans (GCP-V). The Paul-Ehrlich-Institut requests that applications for such trials regarding subsequent amendments that require approval be submitted exclusively in electronic form pursuant to section 10 of the GCP-V.

This also applies to other communications, such as terminations, Development Safety Update Reports (DSURs), temporary holds, urgent safety measures (USM), and result summary reports in accordance with GCP-V for which the initial application was not submitted electronically.

Electronic submissions must be made via the Common European Submission Portal (CESP). Applications via Eudralink or by email will not be accepted and will not be considered as submitted.

Information on Format of Submissions

• Amendments must be submitted in their completed form. Subsequent submissions or additions are not permitted. If late additions are accepted as an exception under special circumstances after contacting the Paul-Ehrlich-Institut (contact: section Clinical Trials, ct@pei.de), the date that the addition is made in the CESP system shall be deemed to be the new application date for the application as a whole.
• Applications cannot be submitted in parallel in hard copy and via CESP. If, as an exception, parallel submission is accepted, the date of the later application is the one that counts.
• The provisions in the GCP-V and in the third publication on clinical trials in humans for the submission of applications that regard the submission of annexes and documents for the approval of clinical trials remain unchanged, even in the case of electronic applications.
• The electronic documents must be submitted in an archive file (e.g. in a Zip, Winrar or 7z format).
• Encryption and passwords for submitted files are not allowed.
• The names of individual files should not be longer than 20-30 characters.
• The names of folders and subfolders should not exceed 120 characters in total.

• The applications should be identified as follows in the subject line of the letter and in the comment line of the CESP application form:
  
  

  Category	Comment line in CESP application form
  Initial CTA/parallel to CTIS application (acc Reg. 536/2014) (ONLY FOR GMO)	Initial CTA-GMO /EuCT-No./ e.g. iCTA- GMO//2023-512400-01-00
  Compassionate use	CU/HFP application / Name Medicine e.g. CU/HFP e.g. xilipixlimab
  Substantial amendment	Subst. Amend. / Vorlage-Nr.: / EudraCT No. // e.g. SA/4998 / 2020-494949-01
  Non-substantial amendment	Non – Subst. Amend. / Vorlage-Nr.: / EudraCT No. / e.g. non-SA / 4998 / 2020-494949-01
  End of trial or premature end of trial	EOT OR pEOT / Vorlage-Nr.: / EudraCT No. // e.g. EOT / 4998 / 2020-494949-01
  Summary report – results	Sum. Report / Vorlage-Nr.: / EudraCT-No. // e.g. SR/4998 / 2020-494949-01
  Annual safety report/DSUR	DSUR / DSUR Number; Reporting period; Vorlage-Nr.: / EudraCT-No., if possible
  Annual safety report/DSUR for several clinical trials	Multi-CT-DSUR; Reporting period
  General information	Gen. Info. / Vorlage-Nr.: / EudraCT No / e.g. GI/4998 / 2020-494949-01
  Interruption, temp hold, restriction of recruiting, etc	Temp. hold or interrup. recruit. / Vorlage-Nr.: / EudraCT- No. Please choose only one
  Urgent safety measures	USM / Vorlage-Nr.: / EudraCT-No. / e.g. USM/4998 / 2020-494949-01
  Fulfilment of condition (without additional changes & incl. naming of procedural step)	Fulf. Cond. / Vorlage-Nr.: / EudraCT-No. / e.g. Fulf. Cond. (SA)/4998/2020-494949-01

  
  

• We ask that you refrain from sending CDs or DVDs to the higher federal authorities in parallel to a CESP submission.
• Only the documents that require a submission in writing (such as objections) should be submitted with signature by post or fax.
• Questions about registration or technical details should be sent by email to:
  cesp@hma.eu.

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