Frequently Asked Questions (FAQs) about 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?

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

Do I have to register my study in a clinical trial registry?

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

Who is responsible for registration and reporting?

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 CTIS?

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

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

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

Am I required to post results in the clinical trial registry when the study is completed, even though I’ve already published the results in a scientific journal?

What is the difference between EudraCT and CTIS?

Does Karolinska Institutet offer support for registration and results reporting?

Why is Karolinska Institutet centralizing clinical trial registration and reporting?

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Compliance & Data Office