From: 10th European Conference on Rare Diseases & Orphan Products (ECRD 2020)
Tool | Description |
---|---|
Protocol | This document defines the strategic objectives of the CML-CAB as well as defining roles and responsibilities for each CAB participant. |
Confidentiality agreement | Addresses the scope of confidentiality discussions during CAB meetings and serves as a legal agreement |
Follow-up Tracker | Allows CML-CAB and sponsor to mutually nominate responsibility for follow-up action |
Documentation | Confidential record of the meeting plus a non-confidential public report for CML-AN members |
Score card | Mechanism whereby CML-CAB can score the performance of the sponsor |
Skills Matrix | Evaluation of the skills of CML-CAB members under the following domains: Research, Access, Collaboration, Drug Expertise and English language skills |