How is information from a clinical trial kept confidential?
This information includes each person’s:
- medical history and diagnosis
- gender and race
- height and weight
- response to the trial medicine – that is, how it worked in treating the person’s disease
- side effects, if any, during the clinical trial.
This information is kept in special trial forms on a computer. On these forms, people are identified only by a trial participant number and when they were born.
Names and other information that can directly identify people, such as an address or personal ID number, is not included on these forms. The link between the trial participant number and the information that can directly identify the person is stored at the clinical trial site. It will be kept for as long as it is required by local laws. This is in line with the regulations of Good Clinical Practice, which apply to all clinical research with people. Names or other information that can directly identify the people taking part will never be shared outside of the clinical trial.
Clinical trial information is protected by the regulations of Good Clinical Practice and any local data privacy laws and regulations that apply. This ensures strict control over who can access the information. Information is kept confidential as far as possible.