Compliance standards.
The guidelines ICG embeds, not references.

Reporting guidelines

Reporting guidelines
embedded from manuscript outline.

• CONSORT — randomised controlled trials
• PRISMA — systematic reviews and meta-analyses
• STROBE — observational studies (cohort, case-control, cross-sectional)
• CONSORT-PRO — patient-reported outcomes in RCTs
• STARD — diagnostic accuracy studies
• SPIRIT — clinical trial protocols
• CARE — case reports

ICH guidelines
structural requirements built in.

• ICH E2C(R2) — Periodic Benefit-Risk Evaluation Report
• ICH E2F — Development Safety Update Report
• ICH E3 — Clinical Study Report structure
• ICH E6 (GCP) — Good Clinical Practice
• ICH E8 — General considerations for clinical studies
• ICH E9 — Statistical principles for clinical trials

Regulatory frameworks
navigation by people who know them.

• EU GVP Module VI — Collection, management and submission of ICSRs
• EU GVP Module IX — Signal management
• CDSCO requirements — India marketing authorisations and submissions
• FDA requirements — IND, NDA, periodic reporting
• EU MDR / MDR 2017 — Medical device regulatory frameworks

Promotional codes
compliance by construction.

• OPPI Code — Indian Pharmaceutical Marketing Practices
• Drug & Magic Remedies Act — Indian advertising restrictions
• IFPMA Code — international promotional practices (where applicable)
• EFPIA Code — European promotional practices (where applicable)

Publishing standards
authorship and ethics handled correctly.

• ICMJE — authorship and contributorship guidelines
• COPE — publication ethics guidelines
• WAME — World Association of Medical Editors standards
• Good Publication Practice (GPP3) — industry-sponsored research