You Are Still Their Doctor

Part of Principal Investigator (PI) Training: Medical Care of the Participant.

About 4 minutes. Free, in your language, no account needed.

Why this matters

Section 2.7.1 is four short lettered points, and together they are the reason this is a physician's course rather than a process course. They say that a trial participant is a patient, that a named physician is responsible for their trial-related medical care and decisions, and that the obligation does not evaporate at the end of a visit or at the end of the study.

Everything a site does around them — scheduling, documentation, monitoring — exists to make that clinical relationship possible, not to replace it.

The four points

§2.7.1(a) — a qualified physician is responsible. A qualified physician, or dentist, or other healthcare professional where applicable regulatory requirements permit, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical decisions. This is the sub-section that defines the boundary of everyone else's role at your site.

§2.7.1(b) — others may be involved in care. Other appropriately qualified healthcare professionals may be involved in participants' medical care. Your ward team, their oncologist, their surgeon, the nurses — all continue to care for the person. What they do not do is make the trial-related decisions.

§2.7.1(c) — adequate medical care for trial-related events. Adequate medical care should be provided for adverse events, including clinically significant laboratory values, related to the trial. Crucially, this extends during and following a participant's participation, and the participant should be informed when medical care is needed for intercurrent illness. That sentence is the subject of the next lesson.

§2.7.1(d) — tell their own doctor. With the participant's agreement, the investigator should inform the participant's primary physician about their participation in the trial.

Why (d) is not a formality

The primary physician letter is often treated as a start-up checkbox, sent once and forgotten. It is a patient-safety control, and its value shows up when something goes wrong somewhere else.

A participant presenting to an emergency department at two in the morning cannot reliably explain which trial they are in, what they may be receiving, or who to call. A general practitioner who knows may prescribe differently, avoid a prohibited medication, or telephone your site before acting.

Two improvements to the standard letter, both free:

Where the participant declines to have their physician informed, that is their right; document the refusal, and consider whether the trial remains appropriate for someone whose usual care will be blind to it.

Boundary cases worth deciding in advance

Three situations recur, and each is easier resolved at start-up than at the bedside.

An unrelated condition found during trial assessments. A screening scan shows an incidental finding; a safety laboratory test reveals an unrelated abnormality. You found it, so you are responsible for ensuring the person is told and appropriately referred. It may not be a trial event at all, and it is still your clinical obligation.

The participant asks you to treat something unrelated. Where you are also their treating physician this is ordinary practice. Where you are not, be clear about which hat you are wearing and route them properly — but never simply decline and leave.

Care that the trial makes necessary but the sponsor does not fund. Raise it with the sponsor, and do not let the funding question delay the care. Principle 1.5 settles the order: the participant's safety and wellbeing prevail.

Key takeaways