Register a new clinical trial or clinical study
There are specific procedures and requirements for registration that differ between clinical trials and clinical studies. Determining if the study is a clinical trial or clinical study is important, as this will determine the necessary regulations and procedures for registration. Identifying specific issues and preparing prior to registration will help in avoiding mistakes and later corrections during the registration process.
The WHO recommends that clinical trials and clinical studies should only be registered once and in only one clinical trial registry. Registering the same study in multiple clinical trial registries must be avoided unless there are specific requirements stipulated by the Sponsor or funding agency. Information regarding international standards for clinical trial registration can be accessed by downloading the "WHO International Standards for Clinical Trial Registries" document on WHO's pebpage.
Prior to registering a new clinical study, it is important to coordinate with all collaborators and other centers, if it is a multicenter or multi-national project, in developing a process for registration and results reporting. This process can start at the planning stages when developing a research proposal for a grant. Many funding agencies, particularly at the European level, allow research proposals to include registration and results reporting in the research budget.
Prior to registration
The registration process at Karolinska Institutet (KI) begins first by informing the Compliance & Data Office (CDO) if the registration is for a clinical trial or a clinical study.
A copy of the ethical approval/application or other “agreement” to confirm KI is the Sponsor for registration and reporting (responsible registrant) should be submitted to CDO at firstname.lastname@example.org. This “agreement” can be formalized in the study protocol, application to Swedish Ethical Review Authority, Medical Products Agency, etc. Information and procedures regarding how to register a new clinical trial or clinical study are accessible in "KI's Clinical Trial Registration & Reporting (CTRR) Instructions" document using the link below.
Registering a new clinical study in ClinicalTrials.gov
When registering a new clinical study in ClinicalTrials.gov, there are specific requirements that must be included in the protocol registration. When the researcher starts a ‘New Record’ for registration, a protocol form will generate. In the protocol registration, there are required fields that must be completed. The following fields must be completed in accordance with KI instructions.
- Record Owner: This can be the lead researcher (referred to as principal investigator [PI] in ClinicalTrials.gov), or a researcher assigned by the lead researcher (PI). If the record owner is not the lead researcher (PI), then the lead researcher (PI) must be added to the ‘access list’ in order to approve and release the protocol registration to NIH for review.
- Unique Protocol ID: This can either be a grant number received for the study protocol by the funding agency, the Dnr number from the ethical approval, or the acronym of the study (if the other two identification numbers are unavailable).
- Sponsor: Karolinska Institutet must be listed as the Sponsor.
- Responsible Party: The lead researcher (PI) must be listed as responsible.
Technical instructions for completing a clinical study registration can be accessed by downloading the "Technical Instructions for Registering a New Study" document using the link below.
Registering a new clinical trial in CTIS
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. A clinical trial application is sent to CTIS, and both the Medical Products Agency and the Ethical Review Authority have access to the application in CTIS, where it is managed jointly. Decisions and any revisions to the application can be viewed and managed by the applicant via CTIS.
KI will have a so-called “organization-centric approach”. Information and instructions regarding this will come soon.
Clinical trial that includes biobank samples
A clinical trial that includes biobank samples requires an approved biobank application. With the new Eu-regulation (EU 536/2014), the biobank application must be sent to the Regional biobank center (Regionalt biobankscentrum), at the same time as the “clinical trial application” is registered in CTIS. Review of the biobank application is then managed in parallel with the assessment of the Medical Products Agency and the Ethical Review Authority. Any revisions to the biobank application are managed in CTIS. For more detailed information about the biobank application process, please visit the webpage Biobank Sverige.
Registering a new clinical trial in EudraCT
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 should be registered in CTIS (Clinical Trials Information System), instead of EudraCT.
The process of applying and registering a new clinical trial should be completed before submitting an application to any of the Member State in which the clinical trial will be conducted. The Swedish Medical Products Agency (MPA) requires that IMP clinical trials be approved and registered in EudraCT. To register a new clinical trial in EudraCT, the process begins by obtaining a unique EudraCT number. The EudraCT number is created in the EudraCT database where all clinical trials conducted in the EU/EEA region are registered. PIP clinical trials conducted outside of the EU/EEA are also registered in the EudraCT database. The application for a EudraCT number can be accessed from the "EudraCT Community Clinical Trial System". To obtain the EudraCT number automatically from the database, the applicant will need to provide a few items of information. A EudraCT number will only be issued once by the system. If a number is issued, but the clinical trial does not proceed, that number is not available for reuse. The EudraCT number is issued via email within 24 hours.
Once an EudraCT number has been obtained for the clinical trial, then researchers must complete the Clinical Trial Application. In the Clinical Trial Application (CTA), applicants must complete the required sections and include the unique EudraCT number, the name of NCA (National Competent Authority), which is the Swedish Medical Products Agency, and have access to the EudraCT public or secure application. Once the CTA is completed, the application must be sent to the MPA and the Swedish Ethical Review Authority. The MPA recommends applications to be sent via Eudralink. Researchers will need an account to access Eudralink, which is accessible at "EMA Account Management". Applications can also be submitted via email to: email@example.com. In the email subject field, include “EudraCT number: Clinical Trial Application.” After the CTA is approved by the MPA and Swedish Ethical Review Authority, the study will be uploaded by the MPA and published on EudraCT as a registered clinical trial. For more information on how to register a study in EudraCT, researchers can download the "Technical Instructions for Registering a New Study" document using the link below.