Inside The Clinic

What this team does

The doctors and nurses who are responsible for the patients in the study.

Decide who is safe to join, watch for side effects and make the medical calls.

Sign off on the data, because their name is on the study at that site.

A day here

1. 8:00Clinic starts. Two of today's patients are study patients, mixed in with everyone else.
2. 10:15A study patient reports dizziness. The nurse takes vitals and calls the investigator in.
3. 11:00Is it related to the study drug? The investigator decides it might be, and it is serious enough to report today.
4. 13:30The nurse completes the safety report with the coordinator. The clock started this morning.
5. 17:00The investigator signs eligibility for next week's patient and reviews three lab reports.

Roles, junior to senior

• Clinical research nurse
• Senior research nurse
• Sub-investigator
• Principal investigator
• Nurse manager, research

1. Clinical research nurseStudy visits, dosing, vitals and the first look at side effects.Clinical Research NurseParticipant Safety and Safety ReportingStudy Conduct and Operational ExecutionParticipant Rights
2. Senior research nurseComplex visits, training other nurses and the nursing side of safety reports.Clinical Research NurseParticipant Safety and Safety ReportingInvestigational ProductQuality
3. Sub-investigatorMedical tasks the principal investigator hands over, on the delegation log.Principal InvestigatorParticipant Safety and Safety ReportingProtocol Interpretation
4. Principal investigatorThe study at the site, legally and medically. Eligibility, safety and oversight.Principal InvestigatorParticipant RightsParticipant Safety and Safety ReportingProtocol Interpretation
5. Nurse manager, researchThe research nursing team, staffing and how studies fit around normal clinic.Clinical Research NurseStudy Conduct and Operational ExecutionCommunication

Who they talk to every day

• Site 204
• Safety Watch
• Terminal C
• The Exchange
• City Hall

Words you will hear

PI

Principal investigator, the doctor in charge of the study at one site.

AE

Adverse event. Anything bad that happens to a patient during the study, related or not.

SAE

A serious adverse event, like a hospital stay. It must be reported within a day.

Eligibility

The rules that say who can join the study and who cannot.

Causality

The doctor's call on whether the study drug could have caused a problem.

Oversight

The investigator staying in charge of what the team does, not just signing at the end.

Common moves in and out

Nurses come in from wards, oncology, emergency and community nursing.

Research nurses move into CRA work, home visit nursing or safety.

Investigators sometimes move to sponsors as medical monitors or into medical affairs.