Clinical data registration (Minimal Essential Data, MED)

Workpackage 2

Subject

Each national or regional myeloma group has its own data registration system activated during clinical trials. Currently there is no standard minimal data set thus inter-study comparability is hampered.

Preview of Programme Proposed

In accordance with EU harmonisation on Good Clinical Practice (GCP) future trial case report forms will fulfill the recommendations. An early aim will be to establish a full set of EUMMNE case report forms (CRF) for

• Newly diagnosed patients with minimal essential data and follw up.
• Active clinical trials.
• Previous trials including a demographic database of late effects.
• Biobank material.

Deliverables and Cooperations

• A set of MED sheets to be used for reporting clinical trial data.
• A clinical Trial Committee composed of individuals from each country, most likely
• from the Myeloma Groups in order to obtain broad European consensus.
• A central randomisation center for MM trials.