Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service.
A G Jaramillo VélezM Aguas CompairedM Granados PlazaEduardo L MariñoPilar ModamioPublished in: European journal of neurology (2020)
The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete.