By Published On: November 15th, 2019Categories: News

If your registry protocol reads like a ‘clinical trial’ then it’s likely to be seen as a clinical trial by ethics committees (EC) and rejected.  You may be restricted by SOP-mandated use of clinical trial protocol templates, which is a common challenge.  However, there are red flags that can be avoided, even within these limitations – Refer to Table 1.


Product Registry Studies, Non-Interventional Studies

Focus of the Research:

Collection of patient-related data in a real-world environment (real-world data) and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through analysis.

Impact of study-inclusion on the Patient:

None/minimal – the treatment and care of the patient remains the responsibility of their treating Physician and is unaffected by the patient’s ‘participation’ in the study

Regional Focus:



Examples of Red Flags

Table 1: Examples (based on our experience) of red flags in protocols that have resulted in approval delays due to EC questions and/or rejections.

Red Flags Include:

Why? Solution

Ambiguity of protocol language gives perception that the decision to prescribe medicinal product taken after inclusion of patients in the proposed study

  • Can be perceived as influencing the healthcare providers prescription habits = Seeding study
  • Protocol language needs to be unambiguous when it comes to inclusion of patients in the registry after the decision has been made to prescribe the medicinal product

Use specific and explicit in language about the fact that patients will either be receiving the product prior to inclusion on study, or the decision to prescribe the product was taken prior to inclusion in the study.  The latter statement may be needed when studying oncology products.

Reference to investigational medicinal products (IMPs)

  • The medicinal product is not investigational.  It is approved and used as per its approval
  • The intent of a product registry is to collect data on medicinal products that patients are already taking prior to study start

Remove all references to IMP

Inclusion of information and/or guidance on how to use IMPs

  • Can be seen as influencing the how the treating physician uses the drug = Treatment intervention
  • Can be perceived as influencing the healthcare providers prescription habits = Seeding study

Do not include information on how to use the medicinal product

Extensive inclusion and exclusion criteria

  • Can be preceived as influencing the treatment and/or healthcare of the patient = Treatment intervention

Limit inclusion and exclusion criteria to essentials only e.g., able to provide informed consent, treated with product of interest

Randomisation of patients to treatment groups

  • This is a treatment intervention = Clinical trial

Ensure that the study design does not involve treatment interventions such as randomisation to treatments

Resources that may be of interest:


> Download the Bite-Sized Insight…‘Red Flags for Regstries’

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