Create a new user account for a clinical trial registry

Prior to registering a new study, researchers must first create a new user account for the specific clinical trial registry. There are specific procedures for registering a new user account in ClinicalTrials.gov and EudraCT.

Introduction

There are different procedures for registering a new user account for ClinicalTrials.gov and EudraCT. For ClinicalTrials.gov, new user accounts for researchers at Karolinska Institutet (KI) are created through the PRS Administrator at the Compliance & Data Office (CDO). To create a new user account in ClinicalTrials.gov, the researcher must contact CDO and make an official request to open a new user account. Requests can be made via email to compliance@ki.se. Researchers will need to provide the following information in their email request: Full name, email address and telephone number for the researcher requesting a new user account. Specific instructions for creating a new user account in ClinicalTrials.gov can be accessed by downloading the "Technical Instructions for Creating a New User Account" document using the link below.

Regarding EudraCT, new user accounts are registered directly through the EudraCT website. Specific instructions for creating a new user account in EudraCT can be accessed by downloading the "Technical Instructions for Creating a New User Account" document using the link below. Information for creating a new user account can also be accessed by downloading "KI's Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below.

Important to note!

From 31 January 2022, a new EU-common regulation will come into application, Regulation EU 536/2014, also called Clinical Trials Regulation. This means that from 31 January, new clinical trials will be registered in CTIS (Clinical Trials Information System), instead of EudraCT. CTIS is a new common web portal and database for clinical trials within the EU. KI will have a so-called “organization-centric approach”. More information about this will come soon.

More information can be found on EMA’s website and at Läkemedelsverket.