Skip to main content

Table 2 The tools used by CML-AN as an internal management and measurement framework

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