Article R4011-1 of the French Public Health Code
The essential safety and quality requirements, referred to in Article L. 4011-2, with which the protocols provided for in Article L. 4011-1 must comply are as follows 4011-1 are as follows: 1° Comply with the good practice recommendations drawn up or validated by the Haute Autorité de santé; 2° Define the quality and safety conditions relating to the purpose of the protocol, with regard to : a) The new intervention…