Clinical Data Review Description of process for Project data Plan providing data to one or manager more clinicians who will complete a clinical review. {Only include if a clinical review will be conducted. If a clinical review will be conducted, this plan would also specify the fields that will be reviewed and the timing of the review. This document may be created well after the initiation of the study in the EDC.} EDC Specifications Describes and tracks the Project data Review Checklist process for review and manager approval of the study-specific EDC requirements (e.g., blank and annotated CRF, edit check plan) prior to the initiation of User Acceptance Testing. Study Startup List of items to be completed Project data Checklist during study startup. manager Study Timeline Projected timeline of study Project events and deliverables manager Sponsor Converted Describes the requirements Project SAS Database of the clinical database that programmer Specifications is delivered back to the sponsor after database lock. {This conversion may not be required. Delete item if not applicable. Alternatively, this may be the specifications for the creation of de-identified public use data} Development and Identifies tasks and Project data Testing Responsibility deliverables for this project manager Matrix and indicates who is responsible for writing, executing, reviewing, and approving each item.
Clinical Data Review Plan Description of process for providing data to one or more clinicians who will complete a clinical review. {Only include if a clinical review will be conducted. If a clinical review will be conducted, this plan would also specify the fields that will be reviewed and the timing of the review. This document may be created well after the initiation of the study in the EDC.} Project data manager EDC Specifications Review Checklist Describes and tracks the process for review and approval of the study-specific EDC requirements (e.g., blank and annotated CRF, edit check plan) prior to the initiation of User Acceptance Testing. Project data manager Study Startup Checklist List of items to be completed during study startup. Project data manager Study Timeline Projected timeline of study events and deliverables Project manager Sponsor Converted Database Specifications Describes the requirements of the clinical database that is delivered back to the sponsor after database lock. {This conversion may not be required. Delete item if not applicable. Alternatively, this may be the specifications for the creation of de-identified public use data} Project SAS programmer Development and Testing Responsibility Matrix Identifies tasks and deliverables for this project and indicates who is responsible for writing, executing, reviewing, and approving each item. Project data manager
clinical-data-management-plan-template_0.docx