China - NIS Training

Course Details

This training course describes the CDISC (formerly the TMF Reference Model) study master file designed specifically non-interventional studies (NIS).

Topics covered:

  1. NIS Regulatory Requirements – What Must I Do?
    • Clinical Trial or Clinical Study?
    • Scope of Reg (EU) 536/2014
    • Interventional or Non-Interventional?
    • Is GCP Applicable to Non-Interventional Studies?
    • What GxPs are Applicable to Non-Interventional Studies?
  2. NIS Regulatory Expectation – What Do I Need to Do?
    • Regulatory foundation and framework for RWR studies
    • We know WHAT to do. But HOW to do it?
    • ISPE Good Pharmacoepidemiologic Practice –Summary
    • Regulations & Guidance
    • Data Integrity
    • Scope of Study Master File Data and Documents
    • Inspectors’ Expectations
    • Regulations –PIC/S 011-3 (Computer Systems)
    • ISPE GAMP® Guides (Computer Systems)
  3. NIS Regulatory Compliance – How Do I Prove I Did it?
    • Standardizing document management approaches for real-world studies
    • Imagine a ‘Trial Master File’ Designed for Your Observational Study…
    • Establishing the Study Master File (SMF)
    • ISPE Good Pharmacoepidemiologic Practice –Example Records
    • Scope of Studies Covered
    • Standardizing Document Management Approaches for Real-World Studies
    • Standard Contents
    • Standard Naming
    • Standard Structure
    • Standard Metadata
    • Structure of RWR Study Master File
    • SMF Adaptability
    • Benefits of the Study Master File
    • Real World Research Study Master File (Concise)
    • Real World Research Study Master File (Detailed)

You Need a Subscription to Access Our Training Modules and Other Services

Billed MonthlyBilled Annually
Save money with an annual plan
Pro
Monthly
Yearly
£3603600
Single Seat License
Ideal for Consultants and Small Organisations
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Cancel Any Time
Sign UpSign Up
Teams
Monthly
Yearly
£7207200
Up to 5 Seat License
Ideal for Medium Sized Organisations
Add Users as Needed (Maximum 5 Users)
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Cancel Any Time
Sign UpSign Up
Enterprise
Monthly
Yearly
£POAPOA
Unlimited Seat License
Ideal for Large Pharmaceutical, Biotech, Medtech Companies and Clinical Research Organisations
Volume Discount Pricing
Unlimited Seat License
Add More Users As Needed
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Personalised Onboarding
Custom Contract
Cancel Any Time
Contact UsContact Us

Academic Pricing

Billed MonthlyBilled Annually
Save money with an annual plan
Academic Pro
Monthly
Yearly
£1801800
Single Seat License
Ideal for Small Research Projects
50% Compared to Commercial Membership
Single Seat Licence
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Cancel Any Time
Sign UpSign Up
Academic Teams
Monthly
Yearly
£3603600
Up to 5 Seat License
Ideal for Medium Sized Organisations
50% Discount Compared to Commercial Membership
Multiple Seat Licence
Add Users as Needed (Maximum 5 Users)
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
NIS Training Modules
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Cancel Any Time
Sign UpSign Up
Academic Enterprise
Monthly
Yearly
£POAPOA
Unlimited Seat License
Ideal for Large Academic and Not-for-Profit Organisations
Significant Discount Compared to Commercial Membership
Unlimited Seat Licence
Add Users as Needed
NIS Training Modules
Monthly RWR Regulatory Updates
Country-Specific NIS Regulatory Requirements
EU MDR Clinical Investigation Roadmaps and Detailed Requirements
Priority Support
Personalised Onboarding
2 Hours Free Expert Consulting per Month
Cancel Any Time
Contact UsSign Up