NIS Links

CHCUK NIS RESOURCES

Free CHCUK Resourcesfree

 

GLOBAL

Applicable Legislation and Guidelines

 

Designing Studies to Support Decision Making

 

Demonstrating Value with Real World Data

Monitoring Guidelines and Resources for Observational Studies

 

Observational Study Reporting Guidelines and ChecklistsCHCUK

 

Guidance for Patient Reported Outcomes (PROs)

 

eCONSENT & eSIGNATURES

Europe

USA

Tools

HUMAN TISSUE RESEARCH and BIOBANKS

Europe

  •  Human Sample Exchange Regulation Navigator (HSERN )

EUROPEEurope-map-colour

Applicable Legislation and Guidelines

Data Privacy and Protection

Post-Authorisation Safety Studies (PASS) EMA

 

Pharmaceutical Self-Regulatory BodyEFPIA

 

Transparency and Disclosure of Transfers of Value Financial-Disclosure

 

EU Databases

 

Human Tissue Research and BiobanksUK-Map-Colour

  •  Human Sample Exchange Regulation Navigator (HSERN )

 

UNITED KINGDOM (UK)

Competent Authority

 

Research Ethics Service

 

UK Applicable Legislation and GuidelinesMHRA_website_logo

 

NHS Observational Data Research ServiceCPRD

  • Clinical Practice Research Datalink (CPRD)
  • Observational data – Access to NHS and other health related data and linked data (suitably anonymised)