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Specific rules for medicines

A trial protocol is required for the application to the Medical Products Agency

For most clinical studies using medicines, authorisation from the Medical Products Agency is also required. The Medical Products Agency’s website has a test to help you determine whether or not your study requires authorisation from the Medical Products Agency (pdf, 154 kB, in Swedish)external link, opens in new window.

A trial protocol must be appended to the application to the Medical Products Agency. For medicine studies involving several clinics, the trial protocol forms the basis for uniform implementation and shall include all the information needed to ensure the participating clinics conduct the study correctly. On its website, the Medical Products Agency provides information on how to conduct clinical trials with medicinesexternal link, opens in new window.

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)external link, opens in new window 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 medicine studies, GCP is defined by the International Conference on Harmonisation (ICH)external link, opens in new window, which includes US, European and Japanese medicine authorities.

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

More on the allocation of responsibility in the Medical Product Agency’s regulations on clinical medicine trials on human subjects (pdf, 96 kB, in Swedish)external link, opens in new window

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

A process overview for studies using medicines is available here.external link, opens in new window

The sponsor is the physical person or legal entity responsible for starting, organising and/or financing the study. In some cases, an individual can be both the sponsor and the principal investigator, and is then the person who both initiates and leads a clinical study. The role thus includes the obligations of both the sponsor and the principal investigator.

The sponsor has overall responsibility for the implementation of the study, and is responsible for issues such as:

  • 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 study is conducted and reported according to the applicable authorisations and rules.

A template/checklist for sponsorship responsibilities is available here.external link, opens in new window

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 study 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 study
  • to appoint qualified personnel who can help in the implementation of the study and also monitor delegated personnel in order to safeguard all processes
  • to take responsibility for delegated personnel receiving suitable training on the study
  • to ensure information on the study is provided, and that consent to participate is obtained according to the applicable rules
  • to draw up procedures for saving all study documentation and to allow monitoring and audit
  • to allow monitoring and audits

The clinical investigator has overall responsibility for the study, 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 study. 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 investigatorresponsibilities 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 study, by carrying out tasks such as:

  • ensuring on location that the study 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 study-related communication

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

  • the product being tested
  • the protocol
  • study participant information
  • the sponsor’s procedures
  • GCP
  • regulatory requirements

Set up systems for data collection, data processing and data storage

Data on the study participants in a clinical medicine study 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 ten years after the study 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).