Who Does What: The Clinical Trial Team

Part of Clinical Research Coordinator (CRC) Training: Clinical Research Foundations.

About 6 minutes. Free, in your language, no account needed.

Why this matters

New coordinators lose weeks to one avoidable mistake: sending a question to the wrong person. Worse, they sometimes answer a question they were never authorized to answer. Knowing who owns each decision protects participants, protects the data, and protects you.

The people outside your site

The sponsor. The organization that takes responsibility for the trial. It may be a pharmaceutical or device company, a university, a hospital, or a government body. The sponsor designs the study, supplies the investigational product, and answers to regulators for it.

The contract research organization, or CRO. Many sponsors hire a CRO to run parts of the trial. ICH E6(R3) treats a CRO as one kind of service provider: the sponsor may transfer trial-related duties to it, but the sponsor keeps overall responsibility for the quality and integrity of the trial data.

The monitor, often called the clinical research associate or CRA. Your main day-to-day contact with the sponsor or CRO. The monitor checks that the trial is being run according to the protocol, that participants are being protected, and that the reported data match your records. Your monitor is not your inspector and not your manager. Treat them as a colleague with a different job.

The regulatory authority. The government body that permits the trial and can inspect it. Examples include the United States Food and Drug Administration, the European Medicines Agency together with national authorities in European Union member states, and national agencies elsewhere.

The ethics committee, called an institutional review board in some countries. An independent group that reviews the study before it starts and continues to oversee it. Module 2, Lesson 3 covers what it does and what it needs from you.

The people at your site

The principal investigator, or PI. The person responsible for the conduct of the trial at your site. The PI makes the medical decisions: whether a person is eligible, whether an event is related to the study treatment, whether a participant should stop treatment. These judgments are not yours and must never be recorded as though they were.

Sub-investigators. Other qualified team members, usually physicians or nurses, to whom the PI formally delegates specific trial duties.

The coordinator. You. The operational center of the site.

The pharmacist or investigational product manager. Receives, stores, dispenses and accounts for the study treatment.

Laboratory and imaging staff. Take, process and ship samples, or perform scans, to the study's specification rather than to routine local practice.

The regulatory or start-up coordinator. At larger sites, a separate person who manages ethics submissions and the site file.

What a coordinator actually does

Across a working week, the role covers five kinds of task.

1. Study preparation. Learning the protocol, preparing source worksheets, supporting ethics submissions, making sure staff are trained and that training is documented.
2. Participant-facing work. Identifying and screening candidates, running the informed consent discussion, conducting visits, answering questions, and keeping people engaged in the study.
3. Data work. Recording what happened in source records, entering data into the study database, and answering queries raised against it.
4. Safety work. Noticing changes in a participant's health, making sure they are documented, and making sure the PI reviews and reports what has to be reported.
5. Records and compliance. Keeping the site file complete and current, hosting monitoring visits, and being ready for an audit or inspection at any time.

The delegation log is the map

Nobody at a site may perform a trial task simply because they are capable of it. The PI records who is authorized to do what, with start and end dates, on a delegation of authority log. If you are not on the log for a task, you do not do the task. If someone leaves the study, the log is updated.

Monitors check this log against what the records show actually happened. A signature from a person not delegated to sign is a finding, even when the work itself was done perfectly.

Communicating and disagreeing well

Different audiences need different things from you. The sponsor wants status and numbers. The ethics committee wants documents and prompt notification of changes. The PI wants problems raised early. The participant wants plain language and a person who will call them back.

Disagreements happen. Common ones are a monitor asking for something the site believes is not required, and a team member wanting to schedule a visit outside its allowed window. Three habits resolve most of them.

• Go back to the document. Most disputes end when someone reads the actual protocol section.
• Put it in writing. An email summarizing what was agreed prevents the same argument twice.
• Escalate without drama. If a request affects participant safety or data integrity, raise it with the PI. If it is unresolved, the sponsor's medical monitor exists for exactly this.

In practice

At Northside Clinic, a participant on VT-201 telephones Nadia to say she was admitted to hospital overnight with chest pain.

Nadia does not decide whether this is related to the study drug. That is a medical judgment and it belongs to Dr. Osei. What Nadia does is record the date and time she was told, gather the hospital details, and inform Dr. Osei the same morning so that he can make the causality assessment and the report can go to the sponsor.

She also does not tell the participant which tablet she has been taking, because Nadia does not know and because the study is blinded. She tells her that if her treating doctors need to know, there is a process that can tell them, at any hour.

Marcus, the monitor, reviews the record at the next visit. Everything he needs is there: who knew what, when, and who decided.

Know which decisions are yours. Make those well, and route the rest fast.

Key takeaways

• The sponsor holds overall responsibility for the trial, and under ICH E6(R3) it keeps that responsibility for data quality and integrity even when duties are transferred to a service provider such as a contract research organization.
• The principal investigator makes the medical judgments at the site, including eligibility, causality and treatment decisions; coordinators document those judgments but do not make them.
• The monitor checks protocol compliance, participant protection and data against source records, and is a working colleague rather than an inspector or a manager.
• A coordinator's work falls into five areas: preparation, participant-facing work, data, safety, and records and compliance.
• The delegation of authority log decides who may do what, and performing a delegated task without being listed on it is a compliance finding regardless of the quality of the work.