Dear colleagues of Regulatory Affairs,
Me and my colleagues from bioemtry team have a question on the CRF to be added as appendices to a clinical study report.
Is is mandatory to include information from external databases in the bookmarded CRF, for patients of interests? Indeed, for our study, not all date were reported directly in the eCRF, but some data, includung central laboratory values, were not directly in the eCRF.
Thank you in advance for your support, and don’t hesitate if my question is not clear enough!
Regulatory Affairs at Inventiva