Frequently Asked Questions (FAQs) with registration and reporting results for clinical trials and clinical studies

This section provides researchers with answers for the most common questions that arise with registration and reporting results for clinical trials and clinical studies.

FAQs

What is the difference between a clinical trial and a clinical study?

Does my study meet the criteria of a clinical trial or clinical study?

Do I have to register my study in a clinical registry even though I've already published my data in a journal?

What are the requirements for registration?

Why is Karolinska Institutet (KI) centralizing clinical trial registration and reporting?

Does my clinical trial require approval from the Swedish Medical Products Agency (MPA)?

Who is responsible for registration and reporting?

Do I need to have ethical approval before I can register a new study?

Can I register a study after patients/participants have been recruited?

Where do I register my study?

How do I register for a new user account in ClinicalTrials.gov or EudraCT?

How do I register a new study protocol on Clinicaltrials.gov or EudraCT?

How often do I have to make updates to the study registration?

How do I report the results on ClinicalTrials.gov and EudraCT?

Am I required to post results in the clinical registry when the study is completed?

Does Karolinska Institutet (KI) offer support for registration and results reporting?

How can I schedule an appointment for online support with my registration and/or reporting results?