Clinical research · GCP · EU CTR · CTIS

Learn the trial.
Think through the case.

A free, role-based learning platform focused on EU/EEA interventional clinical trials of medicinal products for human use. Build knowledge from first principles to inspection-ready practice, then use the Trial Scenario Navigator to reason through common training situations without replacing controlled study procedures.

Explore learning stagesUse the scenario tool
12structured learning stages
10role-based pathways
48knowledge-check questions
Regulatory status — September 2026
For clinical trials of medicinal products for human use in the EU/EEA, Regulation (EU) No 536/2014 (CTR) is the applicable framework and CTIS is the regulatory entry point. ICH E6(R3) Principles + Annex 1 are effective in the EU from 23 July 2025; Annex 2 is adopted and becomes effective on 15 January 2027.
Current practice ≠ future effective guidance
Structured curriculum

Learn the clinical trial lifecycle.

Each stage combines concise theory, operational thinking, official references and the regulatory context behind the work. Unless stated otherwise, regulatory examples are framed for EU/EEA clinical trials of medicinal products for human use under the CTR; local law, protocol and sponsor procedures may add requirements.

Role-based development

Learning paths by role.

Not everyone needs the same depth. These pathways help pharmaceutical companies, CROs, sites and individual learners build role-relevant knowledge without forcing every function through the same sequence.

Practical job aids

Use knowledge at the point of work.

Short, reusable checklists turn course knowledge into day-to-day training prompts. They are not controlled SOPs; use them as learning aids alongside your study documents and quality system.

Consent
Consent conversation check

Before considering the form complete, train the team to verify the process.

  1. Correct approved version?
  2. Enough time and opportunity for questions?
  3. Consent before trial-specific procedures?
  4. Required signatures/dates completed?
  5. Re-consent trigger assessed?
Monitoring
Finding-to-action ladder

Move from observation to meaningful quality action.

  1. State the fact.
  2. Link it to the requirement.
  3. Assess participant/data impact.
  4. Identify cause and recurrence risk.
  5. Track correction/CAPA to closure.
Safety
Safety event mental model

Keep concepts separate before deciding the reporting route.

  1. Event or reaction?
  2. Serious?
  3. Related?
  4. Expected?
  5. What protocol/SOP pathway applies?
Data
Source data integrity check

Ask whether another reviewer can reconstruct what happened.

  1. Attributable?
  2. Contemporaneous?
  3. Original/source defined?
  4. Corrections traceable?
  5. Review and audit trail appropriate?
TMF
Essential-record health check

Filing quality should evidence the trial while it is happening.

  1. Expected record identified?
  2. Filed contemporaneously?
  3. Final/approved version clear?
  4. Owner and location known?
  5. Retrievable for oversight?
Escalation
Deviation triage prompts

Avoid both under-reacting and labelling everything “critical”.

  1. What requirement was missed?
  2. Who/what was affected?
  3. Safety or rights impact?
  4. Data reliability impact?
  5. Is recurrence/systemic risk present?
Regulatory guardrails

Know the rule — and its boundary.

This section highlights high-risk points that are easy to oversimplify. It is a learning summary, not a substitute for the current legal text, CTIS guidance, protocol, sponsor procedures or national requirements.

EU/EEA medicinal-product clinical trials — current training baseline

The CTR applies to clinical trials of medicinal products for human use. Device clinical investigations, IVD performance studies and non-interventional studies follow different legal frameworks and are intentionally outside this site’s operational guidance.

Regulatory review: 9 Sep 2026
In scope

Interventional clinical trials of medicinal products for human use conducted under Regulation (EU) No 536/2014 in the EU/EEA.

Out of scope

Medical-device clinical investigations (MDR), IVD performance studies (IVDR), observational/non-interventional studies and non-EU jurisdiction-specific rules.

Always verify

Approved protocol, IB, current sponsor/site SOPs, national Part II requirements, current CTIS guidance and the effective version of applicable legislation.

≤24 hInvestigator → sponsor: SAEWithout undue delay and no later than 24 hours after knowledge, unless the protocol provides that certain SAEs do not require immediate reporting (CTR Art. 41).
≤7 dFatal / life-threatening SUSARSponsor → EudraVigilance as soon as possible and no later than 7 days after sponsor awareness; incomplete initial reports may require follow-up (CTR Art. 42 / Annex III).
≤15 dOther SUSARNon-fatal / non-life-threatening SUSARs: no later than 15 days after sponsor awareness (CTR Art. 42).
≤7 dSerious breachSponsor notification through the EU portal without undue delay and no later than 7 days after becoming aware (CTR Art. 52).
≤15 dOther unexpected benefit-risk eventUnexpected events affecting the trial benefit-risk balance that are not SUSARs: no later than 15 days from sponsor awareness (CTR Art. 53).
≤7 dUrgent safety measures notificationProtect participants first; sponsor then notifies the event and measures through the EU portal without undue delay and no later than 7 days after measures are taken (CTR Art. 54).
15 dSelected trial lifecycle notificationsCTR Articles 36–38 include 15-day notification periods for specified start/end/recruitment/temporary-halt lifecycle events; check the exact event and article before submission.
≤1 yrSummary of resultsGenerally within one year from the end of the clinical trial in all Member States concerned, subject to the scientific exception described in CTR Art. 37(4).
≥25 yrCTR TMF archiveSponsor and investigator archive the clinical trial master file for at least 25 years after trial end unless other Union law requires longer; subject medical files follow national law (CTR Art. 58).
Do not use these numbers as a generic deadline calculator. They apply to defined CTR events and include conditions, exceptions and starting points. For a real case, identify the event first, then verify the exact article, current CTIS guidance, protocol and SOP before acting. Open the CTR ↗
Greece-specific layer

For trials in Greece, use current EOF / National Ethics Committee information and national implementing requirements in addition to EU rules. EOF’s clinical-trial pages include current national resources and Ministerial Decisions, including 2026 updates. Do not infer a Greek requirement solely from this website. EOF Clinical Trials ↗ · EOF Ministerial Decisions ↗

Free knowledge assessment

Test what you actually understand.

Choose a level and run a randomized assessment. Feedback explains the reasoning instead of only showing right or wrong.

Choose a level.Then start the knowledge assessment.
Official source map

Go back to the source.

The platform summarises concepts for learning. Before any real trial action, verify the current effective legal text, CTIS/authority guidance, approved protocol, Investigator’s Brochure, study manuals, national requirements and controlled organisational procedures.

Safety and reliance notice: clinicaltrials.gr is an independent educational resource and is not a validated clinical-trial system, controlled SOP, decision-support medical device, legal opinion, regulatory submission tool or sponsor-authorised instruction. Do not use it to make participant-care, eligibility, dosing, randomisation, consent, unblinding, IMP disposition, safety-reporting or regulatory-submission decisions. For real work, follow the current approved study documents, authorised systems, responsible personnel and applicable law. Regulatory content can change after the review date shown on this site.
ASCreated byA. SifniotisSenior L&D Expert