Specific rules for medical devices

Specific rules for medical devices Writing a final report Visa mer Visa mindre Writing a final report When a study requires a permit from the Swedish Medical Products Agency, you must write a final report that is available on request, according to

Last modified: 2019-01-15 13.47

Archiving

Archiving When a clinical study is completed, research materials including data and documentation need to be prepared for long-term storage. It is important to research documents are stored and archived in a structured way in order to enable scrutiny

Last modified: 2019-09-11 14.03

Specific rules for medicines

Specific rules for medicines Archiving clinical trials with medicines Visa mer Visa mindre Archiving clinical trials with medicines The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a

Last modified: 2019-01-15 13.48

Specific rules for medical devices

Specific rules for medical devices What shall be archived? Visa mer Visa mindre What shall be archived? Please contact the information owner for information about what is to be archived in your particular study. In general, the sponsor of a study

Last modified: 2019-01-15 13.48

Laws regulations

Laws and regulations When a clinical study is conducted, a number of legal requirements must be complied with in order for the research to be legal. The legislation aims primarily to protect the persons participating in a clinical study, and to

Last modified: 2019-02-20 23.02

Act concerning Ethical Review Research Involving Humans

The Act concerning the Ethical Review of Research Involving Humans The Act concerning the Ethical Review of Research Involving Humans (2006:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure

Last modified: 2019-02-11 10.18

Declaration of Helsinki

Declaration of Helsinki The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association (WMA) in 1964. The Declaration contains ethical principles for doctors and other participants in medical research.

Last modified: 2019-02-20 22.53

Study types

Study types A clinical study is a research study using human subjects to evaluate biomedical or health-related outcomes. On the English version of this website, clinical studies are divided up into the subsidiary groups clinical trial s and

Last modified: 2019-02-20 22.27

Phases clinical trials

The various phases of clinical trials A clinical trial is conducted according to a study protocol set in advance. A trial may last from a couple of weeks up to a year or more, depending on the question, the disease, the nature of the therapy and how

Last modified: 2019-03-04 11.36

Participating in study

Participating in a clinical study Clinical studies are dependent on persons who volunteer to take part. As a study participant, you are part of driving research forward. Page contents: Page contents: What is a clinical study, and why is it carried

Last modified: 2019-03-12 09.01