Medical Record Validation
Cross-source consensus on Medical Record Validation from 1 sources and 5 claims.
1 sources · 5 claims
Other
Highlighted claims
- All potential claims-identified GBS and ADEM cases will undergo medical record request and adjudication. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Confirmed GBS and ADEM cases will be assigned to risk or control windows based on symptom onset rather than claims date. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Two clinicians will independently review GBS and ADEM cases using Brighton Collaboration criteria, preferably with neurologists as reviewers. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- Adjudicators will be blinded to the RSVPreF3 vaccination date. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- For AF, the study will validate the claims-based new-onset algorithm against medical records. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study