Ctms

CTMS User Guide SITE MANAGEMENT TASKS
A step-by-step guide for each exercise performed at a SITE level in CTMS

15_17_25_42_CTMS User Guide for Monitor Version 5.00

Pg 1 of 139 23-Mar-12

Table of Contents
Introduction........................................................................................................................................................................... 3
1. Creating a Site ........................................................................................................................................ 4 1.1 Satellite Sites tracked as Site Accounts ....................................................................................... 11 1.2 Satellite Site Tracked as separate Site Records......................................................................... 13 1.3 Updating Site Status to Feasibility ................................................................................................. 15 1.4 Applying a Site Feasibility Activity Plan ........................................................................................ 17 1.5 Tracking Site Feasibility Activities................................................................................................. 19 2. Creating Pre-Study visit record & Updating Site Status to Pre-Study ...................................... 21 3. Applying a Site Document Package ................................................................................................ 23 4. Tracking Site Documents................................................................................................................... 25 5. Generating Documents within CTMS .............................................................................................. 28 6. Adding Additional Documents to an Existing Document Template .......................................... 32 7. Updating Recruitment CommitmentInformation.......................................................................... 33 8. Applying a Site Milestone Plan ......................................................................................................... 34 9. Tracking Local IEC/IRB and Additional Site Information............................................................. 37 10. Tracking Accounts for a Site........................................................................................................... 38 11. Tracking Contacts and their Roles for a Site ............................................................................... 41 11.1 Tracking Contacts and EDC/ RAVE Roles for a Site ................................................................. 45 11.2 Adding a Monitor to the Site........................................................................................................ 47 12. Updating Site Status to Selected ................................................................................................... 50 13. Creating the Linear and Non-Linear Site Recruitment Plan (Forecasting Subjects) ........... 52 14. Updating Site Status to Committed............................................................................................... 55 15. Tracking Shipment Addresses for a Site....................................................................................... 58 16. Applying an IEC/IRB Submissions Activity Plan.......................................................................... 62 17. Tracking Site Submission Activities.............................................................................................. 65 18. Adding an Activity to an existing Site Activity Plan .................................................................... 67 19. Updating Site Milestones ................................................................................................................ 69 20. Creating a Site Safety Distribution List...