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Low-Intervention Clinical Trials: Key Information and Practical Considerations

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For a clinical trial to be classified as a low-intervention study, all the criteria outlined in Regulation CTR 536/2014, Article 2(3), must be met. These criteria are as follows:

  • The investigational medicinal product (IMP) must have a marketing authorisation (MA).
  • The use of the IMP must comply with the Summary of Product Characteristics (SmPC) or be evidence-based.
  • Participation in the study must not pose risks or burdens beyond what is considered normal clinical practice.

For low-intervention studies, risk-proportionate approaches may be applied. For guidance, refer to the document “Risk proportionate approaches in clinical trials”.  Below is an overview of potential practical implications.

Whether a study qualifies as a low-intervention clinical trial, as well as whether the exceptions mentioned below can be granted, depends on the specific study and is assessed individually during the clinical trial approval process.

 

Risk Adaptation Affected Area Practical Implications
Safety reporting
  • Safety profile of the IMP
  • Reliability of safety information
  • Exemptions may be granted from the recording and reporting of non-serious adverse events (AEs).
  • Reporting of “expected” serious adverse events (SAEs) from investigator to sponsor within 24 hours may be waived.
  • Any adaptations must be described and justified in the protocol.
Handling of investigational medicinal products (IMPs) Traceability and accountability
  • Exemptions may be granted from requirements relating to drug accountability.
  • Exemptions may also apply to extended documentation requirements, such as the preparation of infusion bags.
  • Applications for exemptions must be included in the cover letter submitted with the clinical trial application.
Trial administration Monitoring
  • On-site monitoring is not required for all monitoring activities.
  • Centralised data review may be used.
  • Any adaptations must be described in the monitoring plan.
Trial documentation Content of the Trial Master File
  • Documents may be combined (e.g. screening and recruitment logs, signature and delegation logs).
  • Exemptions may be granted from certain documentation requirements, such as certificates for laboratory accreditation.