Regulations and requirements for clinical trials and clinical studies
The regulations and requirements for clinical trials differ than those for clinical studies. It is important to understand the distinct legal and ethical obligations between registering and reporting clinical trials and those for registering and reporting clinical studies.
Regulations and requirements for clinical trials
There are number of national and international laws and regulations that require clinical trials to be registered and results reported in a recognized clinical trial registry. In Sweden, regulations regarding the registration and reporting of clinical trials adhere to Directive 2001/20/EC of the European Union. These include clinical trials that test investigational medical products (IMP). If a study qualifies as a clinical trial in accordance with the EU Directive, then a Sponsor must be identified, and a EudraCT number must be obtained, followed by authorization from the Medical Products Agency (MPA) and approval by the Swedish Ethical Review Authority (EPM). The MPA requires all approved IMP clinical trials conducted in Sweden to be registered in EudraCT. Information about the application and registration is available on the "Medical Product Agency" website. Information and procedures for registering a new clinical trial in EudraCT can be found on the "Register a new clinical trial or clinical study" webpage.
In terms of reporting results, all clinical trials registered in EudraCT must post trial outcomes. In accordance with the European Commission (EC) Directive 2001/20/EC, Sponsors must ensure that all clinical trials registered on EudraCT report their results within 12 months of trial completion.
Regulations and requirements for clinical studies
If a study does not qualify as a clinical trial, but qualifies as a clinical study, then approval by the Swedish Ethical Review Authority (EPM) must be obtained. The application will identify the research principals. Authorization from MPA is NOT required. These clinical studies do not have a Sponsor, as the term is defined in the EU Directive. However, a Sponsor is required for clinical trial registration. In such cases, it is recommended that the research principal stipulated in the ethical approval serve as the "Sponsor responsible for registration and reporting (responsible registrant)", unless specified otherwise. Research collaborators can also choose another collaborating organization to serve as the "Sponsor (responsible registrant)", however, an agreement with the research principal must be ascertained regarding which organization will assume the responsibility for the registration, reporting, funding, and composing all necessary contracts with all collaborating sites.
Clinical studies should be registered in ClinicalTrials.gov or a similarly approved WHO registry. Clinical studies cannot be registered in EudraCT. The ICMJE states that unregistered clinical studies will not be considered for publication in journals that adhere to ICMJE standards. Information and procedures for registering a new clinical study in ClinicalTrials.gov can be found on the "Register a new clinical trial or clinical study" webpage.
In terms of reporting results in ClinicalTrials.gov, only "applicable clinical trials (ACT)" are required to post results in accordance with the FDA ACT 2007. To determine if a study meets the criteria of an "applicable clinical trial (ACT)", researchers can download the "ACT Criteria Flow Chart" and "ACT Checklist" documents for assistance. Clinical studies registered in ClinicalTrials.gov, on the other hand, are not required to report results by law. The ICMJE, however, requires researchers to meet all results reporting obligations of their funding and regulatory agencies. Karolinska Institutet strongly recommends that all clinical studies registered with KI as the Research Principal/Sponsor to report results in the respective clinical trial registry.
KI’s instructions for registration and reporting
The Compliance & Data Office (CDO) has developed comprehensive instructions for registration and reporting requirements and procedures. These instructions incorporate regulatory information, legal requirements, and procedures for registration and reporting based on directives at Karolinska Institutet (KI), clinical trial registries, and national and international institutions. Detailed information is provided regarding the centralization process of registration and reporting at KI; responsibilities and determination of the Sponsor and research principle; regulations and requirements for registering and reporting results; technical procedures for registration and reporting results; and the timeframe for registering, updating, and reporting results in ClinicalTrials.gov and EudraCT. Researchers are encouraged to download and read through "KI's Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below. For questions regarding registration and reporting, researchers can also contact CDO at email@example.com.