Phase 1 and Small Phase 2 Studies
Process and Deliverables by Stage
Study Start-Up
EDC Support
Help choose the CTMS, eTMF, EDC and IWRS vendor(s)
Create the paper representation of the electronic Case Report Form
Create EDC programming specifications
Create Edit Check Specifications
Program the EDC system (Screens and Edit Checks)
Provide necessary training on the EDC system
Data Management
Review and provide input into the paper representation of the electronic Case Report Form
Perform User Acceptance Testing on EDC system
Create Case Report Form Completion Guidelines
Create Data Validation Plan
Create Data Management Plan
Create Data Transfer Specifications
Study Conduct
EDC Support
Provide ongoing EDC Support
Add users
Answer user’s questions
Reset passwords
Ensure that the system is operating as intended
Interact with the system provider to address any issues that arise during the conduct of the trial
Data Management
Generate status reports on an ongoing basis to assist with trial monitoring
Generate data listings and patient profiles
Review subject’s data to ensure accuracy, consistency and completeness
Issue and resolve queries
Provide support for data safety monitoring boards
Support annual IND updates
Biostatistics
Create Statistical Analysis Plan
Create mock tables and listings
Document exploratory analyses
Program Analysis Datasets
Program SDTM / ADaM submission datasets
Program tables, listings and figures
Program exploratory analyses
Last Patient Last Visit to Database Lock
EDC Support
Provide ongoing EDC Support
Add users
Answer user’s questions
Reset passwords
Ensure that the system is operating as intended
Interact with the system provider to address any issues that arise during the conduct of the trial
Data Management
Generate status reports on an ongoing basis to assist with trial monitoring
Generate data listings and patient profiles
Review subject’s data to ensure accuracy, consistency and completeness
Issue and resolve queries
Provide support for data safety monitoring boards
Support annual IND updates
Perform database lock activities
Biostatistics
Program / Validate Analysis Datasets
Program / Validate SDTM / ADaM submission datasets
Program / Validate tables, listings and figures
Program / Validate exploratory analyses
Database Lock to Study Finalization
EDC Support
Extract subject casebooks and audit trails
Send subject casebooks to the site(s) and sponsor
Biostatistics
Generate / QC final analysis datasets
Generate / QC final SDTM / ADaM submission datasets
Generate / QC tables, listings and figures
Generate / QC exploratory analyses
Create Ad hoc / Post hoc Analysis Plans (if necessary)
Generate / QC Ad hoc / Post hoc analyses (if necessary)
Interact with the medical writer to generate the comprehensive study report
Assist in the creating of presentations and abstracts
Post Study Finalization
Biostatistics
Generate / QC exploratory analyses
Assist in the creating of presentations and abstracts
Creation of ISS and ISE outputs and reports
