Healthcare Social Media Regulatory Compliance Audit Checklist

Role: Senior Medical Regulatory Affairs Director and Healthcare Social Communications Strategist

Context

• Therapeutic category and indication: {{therapeutic_area}}
• Target reader profile: {{target_audience_segment}}
• Deployment channels: {{social_platform_list}}
• Clinical data backing core statements: {{primary_claim_evidence}}
• Pharmacovigilance handling workflow: {{adverse_event_protocol}}
• Governing regulatory framework: {{regulatory_jurisdiction}}

Task

Deliver an exhaustive pre-publication compliance checklist that evaluates draft social media assets against regulatory statutes, ensuring fair balance, appropriate safety disclosures, and risk mitigation across all scheduled channel touchpoints.

Method

1. Review draft copy and creative assets against approved labeling and {{primary_claim_evidence}} for {{therapeutic_area}}.
2. Verify the prominence and readability of risk disclosures alongside efficacy claims to confirm strict fair balance across {{social_platform_list}}.
3. Cross-examine target audience framing against {{target_audience_segment}} to avoid off-label implications or misdirected therapeutic messaging.
4. Audit character constraints, alt-text, pinned comments, and link-out destinations to guarantee immediate access to complete prescribing information.
5. Evaluate visual assets, video storyboards, and audio tracks for non-verbal overstatement of clinical benefits.
6. Integrate {{adverse_event_protocol}} compliance triggers for active community management, comment moderation, and escalation within {{regulatory_jurisdiction}}.
7. Structure verification checkpoints into phased operational gates (Content Accuracy, Fair Balance, Link Integrity, and Pharmacovigilance Preparedness).

Constraints

• MUST cite specific regulatory mechanisms applicable under {{regulatory_jurisdiction}}.
• MUST NOT approve standalone benefit claims without companion risk information within visible viewport boundaries.
• Checkpoints MUST include binary pass/fail criteria alongside required remediation notes.
• Content must differentiate between branded promotional assets and unbranded disease state education.

Output format

• Executive Summary (max 150 words)
• Phased Audit Checklist (4 distinct categorical tables with Columns: Item #, Checkpoint Description, Verification Criteria, Risk Severity [High/Medium/Low], Compliance Status [Pass/Fail])
• Adverse Event Moderation Protocol Checklist (5-8 sequential items)
• Sign-off Approval Matrix

Self-review

• Are all 6 contextual variables explicitly operationalized within the checklist criteria?
• Is fair balance verifiably enforceable across visual, textual, and linked elements?
• Does the checklist provide unambiguous pass/fail boundaries for regulatory reviewers?