1. Study Start Up
1.1. Team Setup
1.2. Handover Meeting
1.2.1. Internal Kick Off Meeting
1.2.1.1. Internal Team Trainings
1.2.2. Review of Pricing/Contract
1.2.3. External Kick Off Meeting
1.2.3.1. Site qualifications
1.2.3.1.1. Site Survey
1.2.3.1.2. Test Transfer
1.2.3.1.3. Site lists on PMED
1.2.3.2. Tracking User Requirements
1.2.3.2.1. Tracking Requirement Specifications
1.2.3.3. Investigator Meetings
1.2.4. Resourcing request
1.2.4.1. SMG
1.2.4.2. GQG
1.2.4.3. Mailbox routing
1.2.4.4. Processing
1.2.5. PMED folder structure
2. Maintenance
2.1. Finance
2.1.1. RAFT
2.1.1.1. Project to date
2.1.1.1.1. SOX Proof
2.1.1.2. Forecast
2.1.2. OSB
2.1.2.1. Pass Through Costs
2.1.2.2. Service Fee Invoicing
2.1.3. Requesting a CIS
2.1.4. O2C (CRS)
2.2. Reader Management
2.2.1. Request of reviewers
2.2.1.1. Reader Approval
2.2.1.1.1. Reader Training
2.2.1.1.2. Cache Setup
2.2.1.1.3. Customer Care
2.2.1.1.4. Reviewer Invoices
2.2.1.1.5. Secondary Reads
2.2.1.1.6. CARE
2.2.1.1.7. Case assignment
2.3. Data reconciliation
2.3.1. DREAM
2.4. Interim and final Exports
2.5. Eligibility Reads
2.6. PD reads
2.7. Paper CRF
2.8. MAT
2.9. Client Meetings
2.9.1. Minutes
2.10. Escalations
3. Close out
3.1. Financial Reconcilitation
3.1.1. Final study report
3.2. Close out meeting
3.3. Central File Archiving
3.4. additional reports
4. MI System
4.1. Export
4.1.1. unvalidated/validated test transfer
4.1.1.1. client approval
4.1.1.1.1. release
4.2. Project Health
4.3. BugZero
4.3.1. DCR
4.3.2. Enhancement
4.4. Analysis
4.4.1. demo
4.4.1.1. release
4.5. MINT
4.6. System Change Requests
4.7. Tracking
4.7.1. CaseManager
4.7.1.1. Radiology/Adjudication/Global
4.7.1.2. Roll back of cases
4.8. Ambra eTransfer
5. PM study transition
6. Documents
6.1. QC spreadsheet
6.2. Site documents
6.2.1. Site operations manual
6.2.2. Image Acquisition Guideline
6.2.3. Translations