What information is collected about me?
The nature of clinical trials makes it necessary for data to be collected about and from you. Every clinical trial will be different in the information it collect, and quite often, it is quite private information that will be collected.
Ask the research team before you take part!
It is important that you ask questions during the consent discussion prior to taking part like:
- What information will be collected?
- Who collects the information and will have access to it?
- Where and how will the information be stored? (for example, electronically, on a single computer or “in the cloud”, on paper?)
- Will my name be attached to the data (identifiable) or will it be coded (de-identified)?
- Who owns the data that you collect?
- How will my privacy be protected?
- Can I get copies of the data you collect about me?
What typically happens with data?
The way data is being collected and stored is changing rapidly with the use of technology like electronic medical records, wearables (like apple watches and fitbts), and mobile phone apps. So the following picture attempts to describe what happens to data in a clinical trial typically. As above, always ask your trial team the specifics for your trial.
How is my identify protected?
Most clinical trials will de-identify the participant. This is done by giving every participant in the trial a unique code number. Any data collected for an individual will then be identified with a number, instead of the name. The list of names and code numbers will usually be kept separate to the data collected for the trial, so as to de-identify the person. However, this data is considered re-identifiable because it is possible if the list of names and codes is put together with the data.
Many clinical trials allow data to be reidentifiable at the trial site level because if a safety issue is identified, they want to be able to figure out the participant that is affected. Usually however, these list of names and codes are not available centrally where the data is collated from lot of different patients and trial sites, minimising the risk of reidentifying someone by accident when there is no safety issue.
Ask your research team how you identity will be protected for your particular trial.
Who will see my data?
This should be outline in the participant information you are provided with before you consent to the trial.
It is possible the following types of people may see your de-identified data:
- The clinical trial site that collect the data
- The people that enter data into a database (if this is a manual process)
- The people that have oversight for the ethical conduct (such as a human research ethics committee) or running of the trial at the trial site (such as a governance officer), if there is an incident that requires investigation
- The people that are responsible for monitoring the study (that make sure the protocol and regulatory guidelines are being following, data is collected properly, and patients safety is monitored)
- The people/organisation that has started the trial, that is, the sponsors of the trial. Sponsors may be commercial or non-commercial organisations.
- The people at a sponsor that are responsible for safety, data analysis, statistics, reporting a trial.
- Regulatory authorities that might inspect a trial site or sponsor are following regulatory guidelines.
If you consent to a trial, you need to be aware of the scope of people that may see your (usually) deidentified data.