Procedures for clinical trials applied to the authorities through CTIS

CT procedures

These procedures are valid from 31 January 2022 when Regulation 526/2014 is implemented.

The procedures with accompanying appendices have been prepared to meet the mandatory requirements described in National and International laws, regulations and guidelines for good clinical research practice “Good Clinical Practice” (GCP).

flowchart of how to use the LM procedures and appendices has been prepared. You can watch a video about the use of the flowchart.

The appendices are practical aids / guiding documents that can be adapted for use in individual clinical trials.

Course material for handling adverse reactions / safety reporting can be found under the tab ‘courses and activities’.

For monitors: Additional relevant documents for monitors can be found here.

Corona adaptations: Special adaptations in some documents can be found here.

If you find errors or omissions in any of the documents, please give us feedback via so we can correct them as soon as possible.

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