Frequently Asked Questions (FAQs)

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

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

Not all clinical studies qualify as a clinical trial under the EU Directive/EU Regulation. For the purpose to clarify the requirements for registration and reporting between clinical trials and clinical studies, Karolinska Institutet (KI) uses the term “clinical trial” (klinisk läkemedelsprövning) to describe “trials that are subject to approval by the Medical Products Agency (MPA)”, as opposed to the term “clinical study” (klinisk studie), which describe other “interventional studies” and “non-interventional studies” that do NOT require MPA approval. Information on the definition of these terms can be accessed on the "Definition of clinical trials vs. clinical studies" webpage. 

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

The Medical Products Agency (MPA) has specific criteria to determine if a study meets the definition of a clinical trial. Researchers can review the requirements by downloading the “MPA Criteria for Clinical Trials” document using the link below.

The International Committee of Medical Journal Editors (ICJME) developed an expanded definition that includes the criteria for clinical studies. The ICJME definition that is used for clinical studies can be accessed at the “ICJME” website. Detailed information on the definition of clinical trials and clinical studies can be accessed on the "Definition of clinical trials vs. clinical studies" webpage. 

Do I have to register my study on a clinical registry?

If your study meets the criteria of a clinical trial, then registration on EudraCT is required. If your study meets the criteria of a clinical study, then registration on ClinicalTrials.gov or a similarly approved clinical registry is required. Information to determine if your study requires registration can be accessed at the “Clinical trials and clinical studies that require registration  webpage.

What are the regulations and requirements for registration?

There are various laws, regulations, and requirements for registration and reporting of clinical trials and clinical studies, which are stipulated by the Food and Drug Administration (FDA) in the United States, the European Commission in the European Union, the Swedish Medical Products Agency (MPA) in Sweden, and Karolinska Institutet (KI). The regulations for registration and reporting differ between clinical trials and clinical studies. Regulatory information and requirements for registration and reporting of both clinical trials and clinical studies can be accessed on the “Regulations and Requirementswebpage. Researchers can also download “KI’s Clinical Trial Registration & Reporting (CTRR) Instructions” document using the link below.

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

A recent report evaluated compliance rates for reporting clinical trial results in EudraCT among European Universities. The results showed that only 17% of European Universities reported their results. It is important to note that greater clinical trial transparency leads to improved patient care, research advances and overall better healthcare systems. Failure to report results in clinical trial registries deprives patients and doctors of complete data to gauge the safety and benefit of treatments. There is an international initiative to increase clinical trial transparency within open science. Given Karolinska Institutet (KI) is committed to this important initiative, the University Director at KI put forth a new directive to centralize the registration and reporting process in order to monitor and support KI researchers with registering and reporting. This initiative was bestowed to the Compliance and Date Office (CDO) within the Research Support Office (RSO) at KI. For more information about centralization, researchers can access the “Centralization of clinical trial registration & reporting webpage.

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

Yes. If the study meets the Medical Products Agency (MPA) criteria for a clinical trial that involves investigational medicinal products (IMP) either under development or approved, then MPA approval is required. Researchers can determine if their clinical trial must be MPA approved by assessing these requirements by downloading the “MPA Criteria for Clinical Trials” document in the link below. Researchers can also access this information at the “Swedish Medical Products Agency Criteria for Clinical Trials”.

Who is responsible for registration and reporting?

The Sponsor responsible for registration and reporting (responsible registrant) is liable for ensuring the study is registered, updated and results are reported. The Sponsor (responsible registrant) can either be the research principal who submits the ethical application, or another organization can be allocated as the “Sponsor (responsible registrant)” through an “agreement” between the research principal and the organization.

The lead researcher (referred to as a principal investigator in clinical registries) is responsible for the actual registering, updating, and reporting results, whereas, the Sponsor (responsible registrant) is responsible for compliance. Detailed information regarding the responsibilities of registration and reporting can be accessed by downloading the “KI’s Clinical Trial Registration & Reporting (CTRR) Instructions” document using the link below.

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

Clinical studies can be registered in ClinicalTrials.gov prior to receiving ethical approval, however, ethical approval must be obtained before recruiting patients/participants to the study.

If registering a clinical trial on EudraCT, the process requires that researchers obtain a EudraCT number, complete the Clinical Trial Application (CTA), and submit it to the Swedish Medical Products Agency (MPA) and Swedish Ethical Review Authority. Once approved, the MPA will upload the CTA to EudraCT, and then it will be approved for registration.

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

No. Studies must be registered prior to patient/participant recruitment in both ClinicalTrial.gov and EudraCT.

Where do I register my study?

Clinical trials involving investigational medicinal products (IMP) conducted in Sweden must be registered in EudraCT. Karolinska Institutet (KI) recommends that non-IMP clinical studies to be registered in ClinicalTrials.gov. However, researchers can also choose to register non-IMP clinical studies in any World Health Organization (WHO) approved Primary Registry. Information regarding registry profiles and a list of WHO approved clinical registries can be accessed by downloading the “International Clinical Trials Registry Platform document using the link below.

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

The process for registering a new user account differs between ClinicalTrials.gov and EudraCT. Information to register a new user account in either ClinicalTrials.gov or EudraCT can be accessed at the “Register a New User Account webpage.

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

The process for registering a new study protocol differs between ClinicalTrials.gov and EudraCT. Information to register a new study protocol in either ClinicalTrials.gov or EudraCT can be accessed at the “Register a new clinical trial or clinical study webpage.

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

Researchers are required to update the study registration at least once a year in ClinicalTrials.gov. If there are any changes to the study protocol (e.g., changes to individual site status or overall recruitment status), the study registration must be updated within 30 days for both ClinicalTrials.gov and EudraCT.

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

Information regarding how to report results in ClinicalTrials.gov and EudraCT can be accessed on the “Reporting Results” webpage. Researchers can also access a full tutorial on reporting results in ClinicalTrials.gov on the “PRS Guided Tutorials” website. Detailed instructions for reporting results in EudraCT are available on the “Tutorials on posting results in EudraCT website.

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

Results for clinical trials must be reported in EudraCT within 12 months of the trial completion by law. The Medical Products Agency (MPA) must be notified the trial is completed and results are posted on EudraCT.

Clinical studies do not require posted results by law, however, Karolinska Institutet (KI) strongly recommends that all registered clinical studies with KI as the Sponsor (responsible registrant) post results in ClinicalTrials.gov or another approved clinical registry. The purpose is to increase clinical trial transparency, thereby, improving advancements in science, medicine and healthcare systems.

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

Yes. Researchers with questions concerning registration and reporting can contact the Compliance & Data Office (CDO) at: compliance@ki.se. CDO also offers online support through a one-hour session for registration and reporting results.

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

Researchers can schedule an appointment for support with registration and/or reporting results at: Session Bookings

 

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