GCP Useful Links

CHCUK GCP TOOLS & RESOURCES

GCP Compliance (Clinical Trials)CHCUK Compilation of GCP Useful Links

CHCUK GCP Resources

CHCUK GCP Training Portfolio

BIOETHICS

COMPILATION OF GLOBAL CLINICAL RESEARCH LEGISLATION

GCP ETHICAL STANDARDS AND GUIDELINES

Regulatory Guidance

PHARMACOVIGILANCE GUIDANCE AND NEWS

INVESTIGATOR INITIATED TRIAL (IIT) GUIDANCE

  • The Investigator Initiated Sponsored Research Association (IISRA) (Now part of the ACRP)
  • IISRA Best Practice Guidelines

eCONSENT & eSIGNATURES

Europe

USA

Tools

HUMAN TISSUE RESEARCH and BIOBANKS

Europe

  •  Human Sample Exchange Regulation Navigator (HSERN )

GCP CONSIDERATIONS – EUROPE

Competent Authority

Applicable Legislation and Guidelines

GCP CONSIDERATIONS – UK

Competent Authority

Research Ethics Service

New Health Research Authority (England)

Applicable Legislation and Guidelines

Useful Resources

GCP CONSIDERATIONS – USA

Competent Authority

Human Research Protections

Applicable Legislation and Guidelines

GCP CONSIDERATIONS – INDIA

Competent Authority

Applicable Legislation and Guidelines