CliniGA CRO

CliniGA CRO Blog

EBS authorization and submission continuity for Türkiye trials

Keep electronic submissions working through staff changes with an authorization register, backup coverage and evidence of dispatch.

Cover image for: EBS authorization and submission continuity for Türkiye trials
Photo: Robert Scoble · License: CC BY 2.0 · Cropped and resized.
Published
Updated
Sources checked

A dossier can be ready while its authorized submitter is unavailable. Türkiye start-up teams should test electronic submission ownership early and preserve continuity when people or service providers change.

Separate EBS from public KAP

TİTCK describes EBS's Clinical Research Module as the submission environment and KAP as the public information portal. Reading a KAP record does not establish a person's authority to submit or sign a dossier. Check the applicable application guidance and official access instructions for the applicant's situation.

Map authority to named people

Our recommended authorization register records the applicant organization, named submitter, signing responsibility, study scope and approved backup arrangement. Include removal and handover steps. Keep passwords and private signing credentials outside the study tracker; sharing an account undermines attribution rather than solving absence cover.

Run a continuity check

  • Confirm that the named applicant and submitting organization match the study documents.
  • Test authorized access and signing arrangements before the internal dispatch date.
  • Record backup responsibilities without creating unauthorized shared credentials.
  • Capture the submitted version, timestamp, receipt and follow-up owner after dispatch.

Preserve the submission evidence

A successful upload is only one checkpoint. Reconcile the receipt against the intended application type and attachments, then monitor questions through a named owner. During provider transition, transfer records and responsibilities before access is withdrawn.

Frequently asked questions

Can KAP access replace EBS access?
No. The public portal and the application module serve different purposes.
Should a backup use the primary submitter's account?
Use an authorized continuity arrangement. Retain individual attribution and follow the official access process.

Sources

  1. TİTCK — Clinical research application guidance and module notes
  2. TİTCK — Clinical research applications, imports and notifications