Professional Practice, Collaboration, and Governance
This domain tests how publication work is governed and delivered across functions. Expect questions on roles, standard operating procedures, cross-functional review, vendor oversight, compliance, documentation, and performance measurement.
Roles and operating model
- Publication professionals manage plans, timelines, approvals, and compliance; they do not independently decide data interpretation or clinical claims.
- Define roles with a RACI or similar matrix across clinical development, biostatistics, regulatory, legal, compliance, HEOR, patient advocacy, and commercial. Commercial teams must not control scientific content or final approval.
- Use a publication steering committee charter to set decision rights, escalation paths, and authorship agreements.
SOPs and documentation
- Written SOPs should cover publication planning, manuscript development, internal review and approval, congress abstracts, disclosure, data sharing, vendor qualification, and document retention.
- Keep version-controlled approvals, disclosure forms, permissions, and data-verification records. An auditor should be able to reconstruct who approved what and when.
- Train staff and vendors on GPP2022, ICMJE, COPE, and company policy; repeat training and audit adherence.
Compliance and vendor management
- Apply transparency reporting rules such as Open Payments or EFPIA disclosure where relevant.
- Separate scientific publication from promotional material. Review promotional use of publications for off-label implications.
- Qualify agencies, use fair-market-value contracts, protect confidential data, and oversee deliverables. The sponsor remains accountable for vendor output.
Worked example
A publication lead finds that a commercial colleague was listed as an author despite not meeting ICMJE criteria, and the medical writer was omitted from acknowledgments. Reasoning: remove the guest author, document the correction, add the writer's name and funding disclosure, inform the publication steering committee, and check whether other manuscripts have the same defect. The fix is not just editorial; it is a governance and training issue.
Traps that cost marks
- Letting commercial or legal teams dictate scientific conclusions.
- Working without a written SOP or approval trail.
- Using unqualified vendors or failing to oversee them.
- Measuring success only by impact factor or publication count.
- Confusing medical affairs and commercial roles.
- Failing to document authorship and disclosure decisions.