en
Dictionary:

Specific rules for medicinal products

Please note: from 31 January 2022, a new EU-wide regulation on clinical trials on medicinal products applies. More information is available on the Swedish Medical Products Agency’s website External link.

A clinical trial on medicinal product needs permission from the Swedish Medical Products Agency

For a clinical trial on a medinical product, a permit from the Swedish Medical Products Agency is required. On the Swedish Medical Products Agency's website, there is a guide that can help you decide whether your study needs a permit from the Swedish Medical Products Agency or not.

A trial protocol must be appended to the application. For clinical trials on medicinal products involving several countries and clinics, the trial protocol forms the basis for uniform implementation and shall include all the information needed to ensure the participating clinics conduct the clinicak trial correctly. The EU Regulation (536/2014) on clinical trials of medicinal products for human use contains information on what must be included in the establishment of a trial protocol for a clinical trial on medicinal products.

Guide to help determine if the clinical trial on a medicinal product needs a permit, the Swedish Medical Products Agency External link.

What should be included in the preparation of a trial protocol, the Swedish Medical Products Agency's website External link.

A template for study protocols (including help text) is available here (in Swedish) External link, opens in new window.

Allocating roles and responsibilities in accordance with Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting and reporting on clinical studies using medicines or medical devices. The purpose of GCP is to safeguard the rights, safety and well-being of the study participants. For clinical trials on medicinal products, GCP is defined by the International Conference on Harmonisation (ICH), which includes US, European and Japanese medicine authorities.

According to GCP, there are a number of roles with varying responsibility to allocate when planning to carry out a clinical study using medicines.

For clinical trials on medicinal products, GCP is defined by the International Conference on Harmonisation (ICH) External link, opens in new window.

More on the allocation of responsibility in the Swedish Medical Product Agency’s regulations on clinical trials of medicinal products on human subjects (in Swedish) External link, opens in new window.

More about the allocation of responsibilities in the EU Regulation (536/2014) on clinical trials on medicinal products for human use, EMA's website External link.

Common questions about GCP on the European Medicines Agency’s website External link, opens in new window.

A process overview for clinical trials on medicinal products is available here. External link, opens in new window.

The sponsor is the person, company, institution or organization that is responsible for starting, organizing and arranging the financing of the trial. In some cases, the sponsor and principal investigator may be the same and is then the one who both initiates and leads a clinical trial on medicinal products. The role thus includes the obligations of both the sponsor and the principal investigator.

The sponsor has overall responsibility for the implementation of the clinical trial on medicinal products, and is responsible for issues such as:

  • all permits from authorities are in place before the clinical trial on medicinal products starts
  • ensuring there are written instructions for work, quality control and quality assurance
  • ensuring instructions are complied with
  • ensuring the study participants are guaranteed financial protection by means of insurance or otherwise

The sponsor may delegate all or parts of its tasks to an individual person, a company, an institution or an organisation, but the sponsor retains responsibility for ensuring the clinical trial is conducted and reported according to the applicable authorisations and rules.

According to GCP, the sponsor must make a risk analysis of the clinical drug trial and, based on this, assess which risks are to be managed and how the trial is to be quality controlled. For more information, see ICH E6 R2.

A template/checklist for sponsorship responsibilities and a template for risk analysis is available here External link, opens in new window.

The monitor is a person appointed by the sponsor, whose responsibility it is to monitor the development of a clinical trial, by carrying out tasks such as:

  • ensuring on location that the clinical trial is conducted, documented and reported according to the protocol, GCP and applicable public agency requirements
  • submitting a written report to the sponsor following each visit to the study site and to report on other clinical trial-related communication

In order to enable the monitor to monitor a clinical trial, he or she needs to have scientific and/or clinical prior knowledge, and also knowledge about:

  • the product to be tested
  • the protocol
  • the sponsor’s routines
  • GCP
  • regulatory requirements

Monitor must be independent of the implementation of the drug test at the clinic.

The clinical investigator shall be a registered medical doctor or dentist and shall have the qualifications in the form of the education, training and experience required to take responsibility for the implementation of the clinical trial and the health and safety of the study participants, including documented training in GCP.

Some of the tasks of the clinical investigator are:

  • to provide the prerequisites for recruiting the agreed number of study participants and to set aside sufficient time to implement the clinical trial
  • to appoint qualified personnel who can help in the implementation of the clinical trial and also monitor delegated personnel in order to safeguard all processes
  • to take responsibility for delegated personnel receiving suitable training on the clinical trial
  • to ensure information on the clinical trial is provided, and that consent to participate is obtained according to the applicable rules
  • to draw up procedures for saving all clinical trial documentation and to allow monitoring and audit
  • to allow monitoring and audits

The clinical investigator has overall responsibility for the clinical trial, but may delegate tasks on condition that the delegation is done in writing. For this reason, a signature and delegation list must be drawn up and kept updated in the event of any personnel changes during the course of the clinical trial. A task must first be delegated before it may be executed by any person other than the clinical investigator.

If there is more than one clinical investigator at a trial site, the sponsor may appoint one of them to be the principal investigator.

A template/checklist for clinical investigator responsibilities is available here External link, opens in new window.

Systems for data collection, data processing and data storage

Data on the study participants, participating in a clinical trial on medicinal products, shall be collected into a data collection form, a Case Report Form (CRF). You can choose between setting up the system in paper format or electronic format. Electronic CRF (eCRF) may constitute the foundation for the database that is created for analyses, while paper CRF need to be converted into electronic data at a later stage. The material must be saved and be readable for at least twentyfive years after the clinical trial has been concluded and reported.

You also need to write plans for data handling (Data Management Plan, DMP) and data validation (Data Validation Plan, DVP).