- Published
- Updated
- Sources checked
Preparing a TİTCK clinical trial application should begin with more than reproducing the folder structure of a previous project. Establish the study scope, applicable guidance version and owner of every document together. This article addresses initial application readiness for clinical trials of human medicinal products from the sponsor, CRO and site perspectives; it does not generalise the separate application pathway for medical device investigations.
Publication and effective dates in the 2026 update
TİTCK's notice of 20 May 2026 states that the application, ethics committee and safety guidance documents were published and entered into effect on 15 May 2026. Record the announcement date separately from the start of applicability. The documents reviewed are KAD-KLVZ-02 revision 10 and KAD-KLVZ-03 revision 09.
Our operational recommendation is to retain more than a link in the project source register. Record the version checked, review date, affected work package and person responsible for reassessment together. This allows a replacement team member to understand the basis of a decision and assess a subsequent update at document level.
Establish a consistent dossier identity before the first EBS-ESY application
Sections 1–2 of KAD-KLVZ-02 describe electronically signed EBS-ESY submissions, use of current templates and identification of documents by date and, where appropriate, version. Exceptions involving physical submission are addressed separately. Do not assume one submission method applies to every project without checking the provisions for special circumstances, including investigator-initiated studies.
Create a dossier identity table at the readiness meeting: protocol code, sponsor, applicant and versions of essential documents. Use it throughout the study. A document that appears complete may still describe the study differently from another document; plan consistency review as a separate deliverable.
Manage the ethics dossier as a separate workflow
KAD-KLVZ-03 identifies the cover letter addressed to the ethics committee and the relevant application documents. It also notes that committees may establish electronic application and correspondence systems. Do not conclude that the technical steps used for the agency submission apply identically to the chosen committee.
We recommend one shared document inventory with separate status records for the two submission pathways. The same protocol version may be used in both, while submission dates, questions received, response owners and decisions remain distinct. This separation makes the impact of a correction in one dossier visible in the other.
Assess reliance provisions for the investigational product dossier
The second revision of KAD-KLVZ-24 became effective on 14 November 2025. It addresses laboratory practices, clinical inspection reports, the investigational product dossier, manufacturing documents and auxiliary products under separate headings. Possession of a foreign authority document does not itself establish acceptance of the Türkiye application; assess its scope and the applicable provision.
Maintain a tracking sheet for supplier documents showing the dossier owner, product or facility scope and outstanding questions. Avoid hiding a specific gap under a general 'product dossier pending' status. Identifying the explanation required and its owner makes handovers between the regulatory team and manufacturer easier to manage.
Check that the scientific dossier and site plan describe the same study
TİTCK's Good Clinical Practice guidance addresses participant rights and confidentiality alongside reliable study data. This supports a readiness review that extends beyond checking filenames. Protocol feasibility and the process explained to participants should be considered together with the operational plan.
In a practical internal review, the team can walk through a protocol visit from beginning to end: where will the procedure take place, who will provide the resources, and whom will staff contact if something unexpected occurs? This is an operational method for identifying uncertainty in an apparently complete plan, rather than a regulatory template.
A readiness checklist for the submission decision meeting
- Scope: has the correct pathway been selected for the product and study type?
- Sources: are the guidance versions and official links retained in a dated register?
- Ownership: does each unresolved issue have one owner and a target date?
- Consistency: have the study identity and visit descriptions been reviewed across documents?
- Readiness: has the authorised team checked submission access and signature arrangements?
- Follow-up: is a record available to track questions, responses and revised documents together?
Use this checklist to support a ready or not-ready decision. Rather than treating an unresolved matter as closed, record its impact, interim approach and decision owner. A sound start-up plan does not promise the absence of deficiencies; it enables the team to retrieve the correct version and rationale when a question arises.
Frequently asked questions
- Which guidance versions were reviewed for 2026 TİTCK applications?
- This article uses KAD-KLVZ-02 revision 10 and, for ethics submissions, KAD-KLVZ-03 revision 09. Both identify 15 May 2026 as their effective date.
- Are the ethics submission and EBS-ESY application the same procedure?
- They are separate submission and assessment workflows. Keep shared documents consistent and maintain the submission, question, response and decision records for each pathway separately.
- Does completing the readiness checklist mean the study is authorised?
- No. The checklist helps the team assess dossier readiness. It does not replace official assessment and authorisation.