Stage 0 · Toolkit 0.5
Safety Data Exchange Agreements
Define safety data exchange obligations between MAHs, CROs, vendors, licensing partners, co-marketers, and service providers.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Safety Data Exchange Agreements.
How it helps your team
Create one controlled operating foundation across teams and development stages.
Designed for
Development leaders, Quality, Regulatory Affairs, programme managers, and cross-functional operational teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- SDEA MAH-Partner Template
- SDEA MAH-Service Provider Template
- PV Responsibility Matrix
- ICSR Exchange Flow Appendix
- Contact List Appendix
- Escalation Pathway Appendix
Excel workbooks
- SDEA Tracker
- Partner Contact List
- Safety Data Exchange Timeline Tracker
- SDEA Obligation Tracker
- Partner Reconciliation Tracker
Related toolkits
Continue within stage 0
Document Control
Control SOPs, templates, trackers, forms, master lists, versioning, review, approval, distribution, archiving, and retirement.
0.2Roles, Responsibilities & Delegation
Define ownership, accountability, delegation, back-up coverage, and cross-functional responsibility.
0.3Training & Competency Management
Ensure personnel, vendors, affiliates, and consultants are trained and competent.