What data a study collects about you

§1 Identifying details

The site records your name, contact details and date of birth so it can reach you and keep your records straight. These details usually stay at the site. Research forms carry a code instead, though some may include initials or a year of birth so labs can match samples correctly.

§2 Medical history and current medicines

At screening the team asks about past illnesses, operations, allergies and every medicine you take, including vitamins and supplements. They may ask permission to look at your hospital or clinic records. Only the parts the protocol needs should be copied into the research forms.

§3 Measurements at each visit

Most visits include measurements such as weight, blood pressure, heart rate and temperature. Some studies add heart tracings, breathing tests or scans. Each result goes into your coded record, building a timeline that shows how you change during the study.

§4 Samples and genetic information

Blood, urine or tissue samples may be tested at the site or sent to a central lab under your code. Some studies ask to store leftover samples for future research or to analyze DNA. These are usually separate choices with their own boxes in the consent form. You can say yes to the main study and no to storage.

§5 Questionnaires and diaries

Studies often ask about pain, mood, sleep, daily activities or quality of life. Some use paper forms, others apps or tablets. Your answers are part of the research data, so the team should explain who reads them and whether anyone checks worrying answers between visits.

§6 Apps, wearables and home devices

More studies now use phone apps, activity trackers or connected blood pressure cuffs. These can collect data continuously, sometimes including location or step counts. Ask exactly what the device records, where that data is sent and whether you can turn any feature off.

§7 Information from your regular records

With permission, some studies link to your ordinary health records, insurance claims or national registries, sometimes for years after the study ends. This helps track long-term outcomes without extra visits. The consent form should say how long the linking continues and how to stop it.

§8 What is usually not collected

A study should not collect information it does not need. It does not normally ask for bank details, unless for payments, or social media accounts. If a form asks for something that seems unrelated to the research, it is reasonable to ask why.

§9 How long the data is kept

Study records are not deleted when your last visit ends. FDA rules require investigators to keep records for at least two years after a drug is approved or the research stops, and many institutions keep them far longer. Stored samples can be held for decades if you agreed to future research. The consent form should give a retention period or explain how long is likely. If no period is stated, ask what happens to your records and samples when the study is finished.

§10 Asking for a data list

You can ask the study team for a plain summary of the information they will collect, how often and for how long. Some sites have a one-page data sheet. Having it in front of you helps when you weigh the main study and any optional extras such as sample storage.

Data checklist

• Ask for a list of data the study collects
• Ask which details stay at the site
• Ask whether samples will be stored
• Check optional boxes for genetic testing
• Ask what apps or devices record
• Ask whether your health records will be linked
• Ask how long collection continues
• Question anything that seems unrelated

Summary table

Definitions

Case report form

The coded research form for each participant.

Source document

The original record, such as a clinic note.

Biobank

A store of samples kept for research.

Genomic data

Information from analyzing DNA.

Wearable

A device worn on the body that records data.

Record linkage

Connecting study data with other records.