Skip to main content
Image coming soon

EU Clinical Trials Regulation Evidence & Implementation Kit

$249.00
Adding to cart… The item has been added
EU Clinical Trials Regulation · Regulation (EU) 536/2014 · Evidence & Implementation Kit
Run EU clinical trials under the CTR, without decoding CTIS and the assessment procedure yourself.
Every CTR obligation handed to you as an adopt-ready control, from the CTIS single submission and the Part I and Part II assessment through informed consent, good clinical practice and SUSAR reporting, with the evidence an inspector examines.
Trial-ready in a weekend, not a quarter.

Here is the honest situation. The EU Clinical Trials Regulation harmonised how trials are authorised and run across the EU: a single submission through the CTIS portal, a Part I scientific assessment and a Part II national and ethical assessment, strict informed consent and vulnerable-subject protections, good clinical practice, expedited SUSAR safety reporting to EudraVigilance, and public transparency of results. Getting the submission, the consent, the safety reporting and the transparency right, and evidencing it, is weeks of work, and a late SUSAR or a weak consent process is exactly where trials get findings.

This Kit removes that interpretation. It is every CTR obligation written as an adopt-ready control you personalize in a weekend, with the evidence an inspector examines.

What you get, the moment you buy

33
Obligations as adopt-ready controls. Every CTR obligation, from CTIS submission and the Part I and Part II assessment through consent, good clinical practice, SUSAR reporting and transparency, written so you personalize and apply it.
33
Evidence-they-examine checklists. For each control, exactly what an inspector examines, plus where trials get findings, so you close the gap first.
1
Clinical Trial Control Matrix, pre-built. Every obligation in a working spreadsheet, ready to record status and evidence location across the trial.
1
Gap & Readiness Assessment. Score each obligation and the workbook returns your readiness as a single percentage, and exactly what to fix next.

Grounded in the EU Clinical Trials Regulation (Regulation (EU) 536/2014), with the CTIS single submission and the Part I and Part II assessment, informed consent, good clinical practice and SUSAR reporting called out. Editable Word and Excel files.

CTIS made it one submission, and one place to get it wrong
The CTR replaced national dossiers with a single CTIS submission and a shared Part I and Part II assessment. That is a huge simplification, but it also means one portal, one set of documents, and one place an inspector looks. This Kit builds the CTIS submission and assessment controls, so your single application is complete and defensible.

What one control looks like

This is the CTIS single submission and the Part I and Part II assessment, where a CTR trial begins. All 33 are built to this depth.

CTR-1 Single application dossier submitted through CTIS CTIS AUTHORISATION
Put this control in place

[Sponsor] shall compile and submit each clinical trial application as a single dossier through the Clinical Trials Information System portal, selecting the intended Member States Concerned and proposing a Reporting Member State, and shall not start any trial until a favourable authorisation decision covering both Part I and Part II is issued and recorded in CTIS.

Regulatory note.

The EU trial number issued at validation is the master identifier used across all subsequent CTIS transactions.

Evidence an inspector examines
  • CTIS application dossier with EU trial number
  • Cover letter and application form snapshot
  • Proposed Reporting Member State and Member States Concerned list
  • Authorisation decision letter stored in CTIS
  • Internal trial start authorisation checklist
Common finding they raise: Trials sometimes initiated on prior national approvals without confirming the CTIS decision is issued and captured.

Why this is not another template pack

  • The evidence is the point. A trial obligation you cannot evidence becomes a finding. This tells you what an inspector examines and where trials get findings, for every obligation.
  • Consent and SUSAR reporting built in. Informed consent, vulnerable-subject protection and the expedited SUSAR reporting to EudraVigilance are written into the controls, the areas inspectors scrutinise.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. The CTR aligns with good clinical practice and the GDPR for trial data, so this work feeds your wider clinical and privacy compliance.

Who buys this

Sponsors and CROs running clinical trials of medicinal products in the EU, and the regulatory, clinical operations and pharmacovigilance leads who own the CTR. Whether it is a first trial or a portfolio, you save weeks and walk in with the submission, consent, safety and evidence structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 33 obligations
✓  A completed clinical trial control matrix
✓  The evidence an inspector examines
✓  Your CTIS submission and consent process anchored
✓  A readiness percentage and a fix list
✓  The common findings closed

Common questions

Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.

Is this legal or regulatory advice? No. It is an implementation toolkit grounded in the Regulation. For a specific trial consult your regulatory function; this gets your controls and evidence in order fast.

Does it cover CTIS? Yes. The CTIS single submission and the Part I and Part II assessment are the first control group.

Does it cover safety reporting? Yes. Adverse event recording and the expedited SUSAR reporting to EudraVigilance, plus the annual safety report, are their own control group.

What if it is not for me? A 30-day money-back guarantee.

Do not decode CTIS and the CTR by hand.
Every CTR obligation is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be trial-ready this weekend.

Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com

!