There are no regulatory guidelines specific for the EORTC QLQ instruments. However, several general guidelines about the use of patient reported outcomes exist, which contains information helpful for the implementation of the EORTC QLQ-C30 and its modules in cancer clinical trials.
Some regulatory guidelines can be found here:
- Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry Final. 2009.
- European Medicine Agency. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies. 2016.
