Resources

Welcome to our clinical trial resource library

Navigate the complexities of clinical research with a knowledge base of curated guidelines, templates, protocols, and toolkits. More resources will be added over time, so make sure to come back every once in a while.

Featured resource

EMA Guidance on Decentralised Clinical Trials

This document was created by experts from the HMA Clinical Trial Coordination Group(CTCG), EC Clinical Trial Expert Group (CTEG), and the EMA GCP Inspectors Working Group (GCPIWG). It aims to inform a harmonised perspective on the use of decentralised elements in clinical trials across the European Union and European Economic Area.

Guideline
Dec 13, 2022

FDA Guidance on Decentralised Clinical Trials

Free
Guidance for Industry, Investigators, and Other Stakeholders
Guideline
Guideline
May 1, 2023

EMA Guidance on Decentralised Clinical Trials

Free
Featured
A harmonised perspective on the use of decentralised elements in European clinical trials
Guideline
Guideline
Dec 13, 2022

FDA Guidance on Informed Consent

Free
Guidance for IRBs, Clinical Investigators, and Sponsors
Guideline
Guideline
Aug 1, 2023

Case-Control Study Design

Premium
Knowledge resource on the key design aspects of case-control studies.
Knowledge Resource
Knowledge Resource
Aug 18, 2023

Randomised Controlled Trial Design

Premium
Knowledge resource on the key design aspects of randomised controlled trials.
Knowledge Resource
Knowledge Resource
Oct 18, 2023

EMA Guidance on Complex Clinical Trials

Free
Questions and answers on scientific and operational aspects of complex clinical trials
Guideline
Guideline
May 23, 2022

EMA Guidance on Computerised Systems & Electronic Data in Clinical Trials

Free
Requirements for computerised systems, including validation, user management, security, and electronic data in clinical trials.
Template
Template
Mar 7, 2023