Clinical Research, Clinical Trials, ICH-GCP Guidelines, Code of Federal Regulations, GDPR, Roles and Responsibilities, Key stakeholders

Kick-off and various other important meetings

Protocol Review

CRF Design considerations by SDTM

Create Edit check specifications including Dynamic Rules, Mapping and Calculation fields

Edit check specification programming

Test cases for edit checks

Edit checks validation or UAT

Online Screen Review Meeting (OSRM)

Investigator Meeting (IM)

Training the users

Setup of standard and custom reports

Develop and Maintain study documents

Budgeting and Finance

Go-Live

(Split go-live)

DBL Meetings

Finalize study documents

Resolve all issues

Complete the DBL checklist

Lock the database

Final data transfer

Archival of database