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Dictionary:

Specific rules for medicinal products

Producing trial files

In clinical trials on medicinal product, Trial Master Files (TMF) must be established, one for the sponsor and one for the clinical investigator. The trial files are established in the initial stage of the clinical trial and is continuously updated. The trial files contain relevant documentation to initiate a clinical trial and documentation that is generated during the clinical trial. ICH-GCP (R6) chap. 8 contains information on what must be in the trial file with the sponsor and the clinical investigator before, during and after the end of the clinical trial. EMA also has a recommendation for what trial file should contain. After completion, it must be possible to reconstruct the clinical trial based on the documentation in the trial files. Trial files for the clinical investigator contains documentation that is important at the own clinic and the trial file for the sponsor contains the total documentation for the entire drug trial. Note that information that can identify study participants must not be in sponsor's trial file.

Information about what should be in the test folder, ICH-GCP (R6) chap. 8 External link.

Recommendations on what TMF should include, EMA website External link, opens in new window.

Templates for table of contents for sponsor- and clinical investigator trial master files are available here. External link, opens in new window.

Implementing monitoring

Monitoring is performed for quality control and is a requirement for clinical trial on medicinal products. The monitoring is carried out by a monitor on behlaf of the sponsor. A monitor may not be involved in the practical implementation of the clinical trial. The monitor must have scientific and/or clinical knowledge about:

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

The monitor shall verify that the protocol is complied with, that laws and regulations are complied with and that the collected data is complete and correctly registered.

Here are templates that can be helpful in planning and carrying out monitoring, as several monitors collaborate within one and the same study (is Swedish) External link.

Notifications in the EU portal for studies carried out in accordance with EU Regulation EU 536/2014

The sponsor must notify via the EU portal when the drug trial has started, when the first study participant has completed the first visit and when the recruitment has ended. The registrations must be made within 15 days.

Information about registration in the EU portal External link.

Reporting side effects

The clinical investigator in a clinical trial on medicinal products is responsible for registering and reporting any side effects continuously. The study protocol defines clearly how this is to be carried out. As the side effect reporting is important both for the persons participating in the clinical trial and for future patients, procedures for side effect reporting must be in place before the clinical trial starts.

 

Summarising an annual safety report

For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC

A safety report with a summary of serious adverse reactions is compiled annually for clinical trials on medicinal products (Development Safety Update Report, DSUR). The report includes an assessment of safety and that the risk / benefit assessment has not been changed during the drug trial. The report is sent to the Swedish Medical Products Agency and to the Swedish Ethical Review Authority.

Information about the annual safety reporting and template for DSUR is available on the Swedish Medical Products Agency's website External link.

For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014

A safety report summarizing serious adverse reactions is compiled annually for clinical trials on medicinal products. The report includes an assessment of safety and that the risk / benefit assessment has not been changed during the clinical trial. The report is submitted to via the EU database CTIS.

Information about the annual safety reporting in CTIS is available on the Swedish Medical Products Agency's website External link.

Ensuring that all data are complete and correct

When the data collection in a clinical trial on medicinal products is completed, the sponsor must ensure that all data registered during the clinical trial is complete and correct. In case of ambiguity, questions are asked to the examiner. When all data entered in the test database has been checked, supplemented and corrected, the database is declared "clean". Thereafter, no changes are made and the statistical analysis of the test can begin.

Reporting that the study is completed

For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC

The sponsor must notify the Swedish Medical Products Agency and the Ethical Review Authority within 90 days that the clinical drug trial has been completed. Within a year, a summary of the results of the clinical trial will be published in the EU database (EudraCT) and a trial report will be prepared.

Information about the completed trial, the Swedish Medical Products Agency's website External link.

For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014

The sponsor must within 15 days via the EU portal CTIS notify that the clinical trial has been completed. Within a year, a summary of the test results must be submitted via the EU portal. In addition to the publication, a written summary of the results must also be prepared, which is written in a way that is understandable to lay people.

Information for sponsors on notification of completed clinical trial on medicinal products, the Swedish Medical Products Agency's website External link.