Adjudication Statement Sample
CORRONA PSORIASIS REGISTRY
ADJUDICATION CHARTER
Version 1.0 | DD-MMM-YYYY
TABLE OF CONTENTS
1 INTRODUCTION 3
2 SCOPE 3
3 ADJUDICATION ROLES 3
4 TARGETED EVENT REPORTING PROCEDURES 4
5 EVENT CLASSIFICATION 4
6 ADJUDICATION DOSSIER REQUIREMENTS 4
7 EVENT VALIDATION AND ENDPOINT REPORTING 5
Figure 1 – Endpoint Adjudication Workflow 6
8 REFERENCES 7
1 INTRODUCTION
The purpose of this document is to describe endpoint adjudication procedures for the Corrona Psoriasis Registry (Corrona-PSO-500).
2 SCOPE
Case adjudication is completed for select adverse events of special interest within the Registry population. Targeted Events occurring in eligible subjects after the date of registry enrollment …show more content…
Each adjudication team is led by a chairperson with established, relevant therapeutic expertise, as well as research and publication experience. Teams are composed of medically qualified, trained reviewers identified by the team chairperson as having the appropriate skills, experience, and capacity to support the project and adhere to process requirements.
Team Chairperson Affiliation
Cardiovascular Michael Farkouh, MD University of Toronto
Mount Sinai Medical Center
Malignancy Mark Fisher, MD, MPH Massachusetts General Hospital
Serious Infection Jeffrey Curtis, MD, MS, MPH University of Alabama …show more content…
6 ADJUDICATION DOSSIER REQUIREMENTS
Document packages are prepared for adjudication according to the procedure defined in PV-60-03: Case Adjudication Assignment and Tracking. Per this procedure, all case packets include a copy of:
- TAE Questionnaire data submitted by the site
- Available supporting documentation for the reported event(s) excluding personal identifiers and treatment exposure details
- Adjudication Response Form (Appendix A) pre-populated with subject ID, event term and event onset date.
7 EVENT VALIDATION AND ENDPOINT REPORTING
Adjudication is completed according to the procedure described in PV-60-04: Case Adjudication Completion.
Adjudication Response Forms are used by each team to capture the final determinations of results for reviewed cases. Adjudicator validation of key data fields are completed as part of the review that includes but is not limited
ADJUDICATION CHARTER
Version 1.0 | DD-MMM-YYYY
TABLE OF CONTENTS
1 INTRODUCTION 3
2 SCOPE 3
3 ADJUDICATION ROLES 3
4 TARGETED EVENT REPORTING PROCEDURES 4
5 EVENT CLASSIFICATION 4
6 ADJUDICATION DOSSIER REQUIREMENTS 4
7 EVENT VALIDATION AND ENDPOINT REPORTING 5
Figure 1 – Endpoint Adjudication Workflow 6
8 REFERENCES 7
1 INTRODUCTION
The purpose of this document is to describe endpoint adjudication procedures for the Corrona Psoriasis Registry (Corrona-PSO-500).
2 SCOPE
Case adjudication is completed for select adverse events of special interest within the Registry population. Targeted Events occurring in eligible subjects after the date of registry enrollment …show more content…
Each adjudication team is led by a chairperson with established, relevant therapeutic expertise, as well as research and publication experience. Teams are composed of medically qualified, trained reviewers identified by the team chairperson as having the appropriate skills, experience, and capacity to support the project and adhere to process requirements.
Team Chairperson Affiliation
Cardiovascular Michael Farkouh, MD University of Toronto
Mount Sinai Medical Center
Malignancy Mark Fisher, MD, MPH Massachusetts General Hospital
Serious Infection Jeffrey Curtis, MD, MS, MPH University of Alabama …show more content…
6 ADJUDICATION DOSSIER REQUIREMENTS
Document packages are prepared for adjudication according to the procedure defined in PV-60-03: Case Adjudication Assignment and Tracking. Per this procedure, all case packets include a copy of:
- TAE Questionnaire data submitted by the site
- Available supporting documentation for the reported event(s) excluding personal identifiers and treatment exposure details
- Adjudication Response Form (Appendix A) pre-populated with subject ID, event term and event onset date.
7 EVENT VALIDATION AND ENDPOINT REPORTING
Adjudication is completed according to the procedure described in PV-60-04: Case Adjudication Completion.
Adjudication Response Forms are used by each team to capture the final determinations of results for reviewed cases. Adjudicator validation of key data fields are completed as part of the review that includes but is not limited