Roles and Responsibilities in Clinical Trials

Part of Fundamentals of Clinical Research: Principles and the Regulatory Framework.

About 1 minutes. Free, in your language, no account needed.

Roles and Responsibilities in Clinical Trials

A clinical trial works only when every party knows what it is responsible for. ICH E6(R3), the current international guideline for Good Clinical Practice (adopted 6 January 2025), organizes its Annex 1 around three of those parties: the institutional review board or independent ethics committee (section 1), the investigator (section 2) and the sponsor (section 3). The people who do the daily work at a site, such as coordinators and monitors, act under those responsibilities.

The Institutional Review Board or Independent Ethics Committee (IRB/IEC)

The IRB/IEC protects the rights, safety and well-being of participants. Before a trial starts, it reviews the protocol, the informed consent materials, recruitment materials and the investigator's qualifications, and it gives its opinion in writing. It continues to review the trial while it runs, including changes to the protocol and new safety information. A site may not enroll anyone until the IRB/IEC has given a favorable opinion.

The Investigator

The investigator (often called the principal investigator) is responsible for the conduct of the trial at the site. That includes:

• Making sure the team is qualified and trained, and keeping a record of who has been delegated which tasks.
• Obtaining and documenting informed consent before any trial procedure.
• Following the protocol, and documenting and explaining any deviation from it.
• Making trial-related medical decisions and making sure participants get appropriate medical care.
• Reporting serious adverse events to the sponsor immediately after becoming aware of them.
• Keeping accurate, complete source records and essential documents.

The investigator can delegate tasks, but not responsibility. If a coordinator makes an error on a delegated task, the investigator remains accountable for it.

The Sponsor

The sponsor is the company, institution or organization that takes responsibility for starting, managing and financing the trial. The sponsor designs the protocol, selects qualified investigators and sites, supplies the investigational product, monitors the trial, manages and analyzes the data, assesses safety information and reports to regulators as required. A sponsor may hand tasks to a contract research organization (CRO), but the sponsor keeps overall responsibility for the trial.

Roles You Will Meet at a Site

• Clinical research coordinator (CRC): runs the study day to day under the investigator's delegation: scheduling visits, supporting consent, collecting data and keeping records current.
• Clinical research associate (CRA) or monitor: works for the sponsor or CRO and checks that the trial follows the protocol and GCP and that the data match the source records.
• Pharmacist or investigational product manager: receives, stores, dispenses and accounts for the investigational product.
• Data manager: enters or reviews data and resolves queries.

Participants

Participants are not staff, but the whole system exists to protect them. They have the right to clear information, to ask questions, to have their data kept confidential and to withdraw at any time without giving a reason and without losing the care they are otherwise entitled to.

Check Your Understanding

1. A coordinator obtains consent on a delegated task and misses a signature. Who is accountable? The investigator, because delegation transfers the task, not the responsibility.
2. Who gives the favorable opinion that must exist before the first participant is enrolled? The IRB/IEC.
3. A sponsor uses a CRO for monitoring. Who is responsible for the quality of that monitoring? The sponsor.