Estudios Clínicos y Preclínicos​ - Inglés

Substantial Modification

Substantial Modification

In the event that any project undergoes relevant changes in its documentation, a request for evaluation of the changes made must be submitted to the IECm.

Any change to any aspect of the clinical trial that is made after notification of the decision referred to in Articles 8, 14, 19, 20 or 23 of Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014, and that may have a substantial impact on the safety or rights of the trial subjects, or on the reliability and robustness of the data obtained in the clinical trial. ​

In the case of observational studies, a relevant change is considered to be:

Any aspect of the observational study that may have a significant impact on the safety, physical, or mental well-being of the participating subjects, such as:

  • Changes to the patient information sheet and/or informed consent form related to safety issues.
  • De cualquier aspecto del estudios observacional que pueda afectar a los resultados obtenidos en el estudio y a su interpretación, como:​
    • Changes to the primary or secondary endpoints of the study.
    • Changes in the study population.
    • Change in information sources and data collection methods.
    • Changes to the definition of major exposure.
    • Changes to the definition of the main outcome variable.
    • Changes in the follow-up time of participating subjects.
  • The inclusion of new sources of funding.

The deadline for submission is linked to the calendar of IECm meetings, the amendment shall be submitted at least five working days before the date of the selected assessment meeting. Check the current calendar of meetings here.