Roles and Responsibilities in Clinical Research

When something goes wrong in a clinical trial, the cause is often not that one person did their job badly. It is that a task fell into the gap between two people who each assumed the other had it: the eligibility check no one was assigned, the safety report each party thought the other was filing, the assessment performed by someone never authorised to do it. Harm in a trial hides less inside any single role than in the spaces between roles that were never clearly divided.

A trial is not run by an organisation. It is run by named people, each holding a defined piece of responsibility, with the boundaries between those pieces written down. When the boundaries are clear, every task has an owner and every problem has a path to escalation. Ambiguity about who is responsible is not administrative untidiness — it is itself a safety risk, which is why GCP treats clear, documented roles as a requirement rather than good housekeeping.

Learning Objectives

After this module, you can:

• Identify the parties in a clinical trial and name what each is responsible for
• Distinguish a sponsor transferring an activity from an investigator delegating one — and state what neither can hand off
• Locate the coordinating investigator and the lead ethics committee in a multicentre Swiss trial
• Apply the rules for documenting delegation, and spot a delegation log that would fail an inspection
• Decide how much oversight a transferred or delegated activity needs

The Cast of a Clinical Trial

Before going deep on any one role, it helps to see the whole cast at once. A clinical trial of a medicinal product in Switzerland can involve all of these parties — though, as we'll see, not every trial uses every one:

• The sponsor — takes responsibility for initiating, managing, and financing the trial.
• The investigator (the principal investigator, or PI) — the person responsible for the conduct of the trial at a given site.
• The sub-investigator — a qualified team member, often a physician, supporting the PI under delegation.
• The study coordinator and study nurse — the team members who run the day-to-day conduct of the trial at the site under the PI's authority.
• The monitor — appointed by the sponsor to check, through monitoring visits, that the site is running the trial correctly.
• Service providers — outside organisations the sponsor or investigator uses to carry out specific trial activities.
• The ethics committee — the independent body that reviews and approves the trial to protect participants.
• The competent authority — in Switzerland, Swissmedic for trials of medicinal products — the regulator that authorises and inspects.

That is the cast. The rest of this module explains what each one owns, and — more importantly — how responsibility moves between them without ever fully leaving the person it started with.

Transfer and Delegation: The Principle Behind Every Role

Here is the single idea that makes sense of every role you just met. Almost no investigator runs a trial single-handed — work is nearly always handed to the site team — and a sponsor will often, though not always, hand some activities to an outside organisation as well. ICH E6(R3) gives these two movements different names on purpose, and the difference is the most useful thing in this module.

• A sponsor transfers an activity (to a service provider).
• An investigator delegates an activity (to a member of the site team).

In both cases the activity moves, but the responsibility does not. The sponsor who transfers data management to a vendor still answers for the quality of that data. The investigator who delegates blood draws to a study nurse still answers for whether they were done right. Transfer and delegation move the hands; they never move the accountability.

This is the R3 reframing worth internalising. Earlier guidance talked mainly about the "CRO" — the contract research organisation a sponsor pays to run trial operations. R3 widens and sharpens the concept into the service provider: any person or organisation, commercial, academic, or other, providing a service used by either the sponsor or the investigator to fulfil trial-related activities. ICH E6(R3) The CRO is now just one kind of service provider — the glossary literally redirects "Contract Research Organisation" to "Service Provider." The point of the broader term is that the same rule governs all of them: whoever you hand the work to, you keep the responsibility for it.

Read Principle 10 as three claims that build on each other: you may hand the work out; doing so does not hand out the responsibility; and because the responsibility stays, you owe the work continued oversight. Sections further down unpack the oversight obligation in practice. For now, hold the spine of it: activities move, accountability stays, oversight is the price of keeping it.

The Sponsor

The sponsor is the individual, company, institution, or organisation that takes responsibility for initiating, managing, and arranging the financing of a clinical trial. ICH E6(R3) In Swiss law the definition adds a national hook: the sponsor must be a person or institution headquartered or represented in Switzerland that takes responsibility for organising the trial here. KlinV

The sponsor's responsibilities run the length of the trial, and most of them are about setting things up correctly and then watching that they stay correct:

• Designing the trial. The sponsor is responsible for a scientifically sound, operationally feasible protocol. ICH E6(R3)
• Allocating the activities. Before the trial starts, the sponsor determines the roles and allocates the trial-related activities — deciding what it will do itself and what it will transfer to service providers. ICH E6(R3)
• Putting agreements in writing. Agreements with the investigator/institution, with service providers, and with bodies such as an independent data monitoring committee must be documented before those parties begin their activities. ICH E6(R3)
• Overseeing the whole thing. The sponsor must maintain oversight of the trial — covered in its own right at the end of this module.
• Running safety and monitoring. The sponsor manages pharmacovigilance — collecting adverse-event reports, evaluating them, and reporting serious unexpected reactions onward — and runs the monitoring programme that checks each site. Both have their own homes: safety reporting in Module 13, monitoring in Module 14.

The thread running through all of these is that the sponsor is the organising mind of the trial. It does not usually see participants. It is responsible for the conditions under which everyone who does see participants can do their job correctly.

When the investigator is also the sponsor

In academic and investigator-initiated research, one person frequently designs the study, finds the funding, and runs it. That person is a sponsor-investigator: an individual who both initiates and conducts a trial. ICH E6(R3) Swiss law reaches the same place from the other direction — an investigator who takes responsibility for organising a trial is also a sponsor. KlinV

The label is not a formality. A sponsor-investigator carries the obligations of both roles at once: the sponsor's regulatory submissions, agreements, oversight, and pharmacovigilance, on top of the investigator's duties to participants at the site. It is the heaviest seat in clinical research, and it is routinely taken by clinicians whose training prepared them for the investigator half and not the sponsor half. If that is you, the practical warning is simple: the sponsor duties do not become optional just because no company is present to perform them.

The Investigator and the Site Team

The investigator is the person responsible for the conduct of the clinical trial at a trial site. ICH E6(R3) When a team runs the trial, the investigator is the responsible leader of that team — the principal investigator. Swiss law frames the role around the people in the room: the investigator is the person responsible in Switzerland for the conduct of the trial and for the protection of the participants at the site. KlinV

A site has exactly one principal investigator — the single point of ultimate accountability for everything that happens there — even when several sub-investigators and a larger team work beneath them. Accountability does not divide across the team; it concentrates in one named person. That is the whole reason the role exists: so that, however many hands touch the trial, there is never any doubt about whose responsibility the site is.

The PI's core, non-transferable obligations include:

• Being qualified, and ensuring the team is. The PI must be qualified by education, training, and experience, and must ensure every person performing a trial activity is qualified for it. ICH E6(R3)
• Following the protocol. The trial must be conducted in compliance with the protocol that the ethics committee approved; deviations are documented and, where significant, reported. ICH E6(R3)
• Owning the medical decisions. A qualified physician — who is the investigator or a sub-investigator — is responsible for trial-related medical care and the medical decisions made on a participant's behalf. ICH E6(R3)
• Standing behind the records. The PI is responsible for the accuracy, completeness, and integrity of the data recorded at the site. ICH E6(R3)

Consent sits here too — ensuring valid informed consent is obtained before any procedure is the PI's responsibility — but the how of consent is large enough to have its own module. ICH E6(R3) The mechanics, special situations, and re-consent triggers are covered in Module 7.

Around the PI sits the rest of the site team, and the word that defines each of them is delegated:

• A sub-investigator is a qualified team member — frequently a physician — to whom the PI delegates trial-related medical tasks such as eligibility assessment, examinations, or causality judgements. The sub-investigator works within their delegated scope; the medical-care responsibility under §2.7.1 can rest with them precisely because they are qualified to hold it.
• A study coordinator typically runs the operational spine of the trial at the site — scheduling, source documentation, communication with the sponsor and the monitor, and keeping the site files in order.
• A study nurse carries out delegated clinical tasks: visits, sampling, administration of the investigational product, and participant contact.

These are real roles with real responsibility for the tasks delegated to them. What they are not is the holder of ultimate accountability for the site. That stays with the PI. The distinction matters most for anyone who is not the PI: your job is to work inside the scope you were delegated, and to flag uncertainty rather than quietly extend that scope. Doing a task you were never delegated, however competently, is not initiative — it is a gap waiting to be found.

The Ethics Committee and the Competent Authority

Two parties sit outside the trial team and provide independent control over it. M3 introduces them as members of the cast; the work they do has its own homes elsewhere in the course.

The ethics committee — the independent review board (IRB/IEC) — is a body of medical and non-medical members whose job is to protect the rights, safety, and well-being of participants, and to give public assurance of that protection, principally by reviewing and approving the protocol, the consent materials, and the suitability of the investigator and site. ICH E6(R3) In Swiss law, the committee assesses whether a research project and its conduct meet the ethical, legal, and scientific requirements of the Human Research Act. HRA Swiss ethics committees are organised at cantonal level HRA and coordinate nationally through swissethics, their joint association. How a committee reviews a dossier, and what it assesses, is Module 5; the ongoing relationship with the committee once the trial is running — amendments, safety reports, end-of-trial notification — is Module 9.

The competent authority is the regulator. For clinical trials of medicinal products in Switzerland, that is Swissmedic: the sponsor submits the trial to Swissmedic, which reviews and authorises it before it begins (with the lowest-risk category exempt from that approval). KlinV Swissmedic also inspects sites and sponsors for GCP compliance (inspections themselves are covered in Module 11). Trials of medical devices run under a separate ordinance — also with Swissmedic as competent authority, not, as is sometimes assumed, a different agency — and are dealt with where devices are, in Module 10. ClinO-MD The precise division of labour between the ethics committee and Swissmedic, and how trials are sorted into risk categories, belongs to the Swiss-law framework in Module 6.

The reason to meet these two here, rather than only in their own modules, is that they complete the picture of accountability: the sponsor and investigator run the trial, and the ethics committee and the competent authority are the independent checks that neither of them can overrule.

Multicentre Trials and the Coordinating Investigator

Most of what we have said assumes a single site. Many trials run at several. A multicentre trial is one conducted under a single protocol at more than one investigator site, ICH E6(R3) and it adds one role and one piece of machinery.

The role is the coordinating investigator: an investigator given responsibility for coordinating the investigators across the different sites. ICH E6(R3) Swiss law mirrors this — the coordinating investigator is the person responsible in Switzerland for coordinating the investigators at the individual trial sites. KlinV Each site investigator remains the PI for their own site, fully responsible for conduct there; the coordinating investigator does not absorb that responsibility, but holds the trial together across sites and acts as the point of contact for the cross-site picture.

The piece of machinery is the lead committee. Rather than every site's cantonal ethics committee reviewing a multicentre trial independently, Swiss law routes the application through a single lead committee, with the coordinating investigator submitting it. KlinV What the lead committee does — how it leads, and how the other involved committees fit in — is part of the ethics-review process in Module 5; here it is enough to know that the coordinating investigator is the person who carries the trial to it.

The Delegation Log

Now to the mechanism that makes delegation real on the ground. An investigator may delegate trial-related activities to other persons or parties — but the delegation has to be recorded. The investigator must maintain a record of the persons and parties to whom trial-related activities have been delegated. ICH E6(R3) In practice this record is the delegation log (sometimes a delegation-of-authority log), and it captures:

• Who is authorised to perform which trial-related activities,
• evidence that they are appropriately qualified and trained for those activities, ICH E6(R3)
• the dates authorisation began and, where relevant, ended, and
• the PI's signature confirming the delegation.

The non-negotiable rule is sequence: the delegation is documented before the person performs the task, because the qualification and authorisation have to exist before the work, not be reconstructed after it. R3 adds a proportionality nuance worth knowing — the amount of documentation should match the significance of the activity, and where an activity is performed as part of ordinary clinical practice, separate delegation documentation may not be required. ICH E6(R3) That nuance scales the paperwork; it does not weaken the core sequence for trial-specific tasks.

This requirement is binding in Switzerland through the door that makes all of GCP binding here: Swiss law requires trials to be conducted according to the rules of Good Clinical Practice. KlinV The delegation log is one of the most concrete, most frequently inspected expressions of that requirement.

Proportionate Oversight: What Can Never Be Handed Off

We end where Principle 10 began, on the part that cannot be given away. The sponsor transfers, the investigator delegates — and each must then maintain appropriate oversight of what they handed out. The defining feature of R3 is that this oversight is not a fixed quantity. It is proportionate: scaled to the nature of the activity and to the risk it carries.

For the investigator, the level of oversight of a delegated activity should depend on the nature of that activity and be proportionate to the importance of the data being collected and the risks to participant safety and data reliability. ICH E6(R3) For the sponsor, the range and extent of oversight should be fit for purpose and tailored to the complexity of and risks associated with the trial — and the selection and oversight of investigators and service providers is named as a fundamental feature of that oversight. ICH E6(R3)

What this rules out is a single answer to "how much should I check?" A delegated task that touches the primary endpoint (the trial's main outcome measure) or participant safety earns close, frequent oversight; a low-risk administrative task earns light oversight. Spending the same effort on both is not diligence — it is a failure of proportion that starves the activities that actually matter.

This is the through-line of the entire module. You can hand out almost any task in a trial. You cannot hand out the responsibility for it, and you cannot hand out the duty to keep watching it. Every role in the cast — sponsor, investigator, sub-investigator, coordinator, nurse, monitor, service provider — exists because someone, at some point, treated a handed-over task as a handed-over responsibility, and a participant paid for the difference.

Module Summary

A clinical trial is a structure of named responsibilities around a participant who cannot protect themselves. The sponsor organises and oversees; the investigator conducts and protects at the site; the team works within delegated scope; the ethics committee and the competent authority check from outside. Activities move between them constantly — but accountability stays put, and oversight is the price of keeping it.

You can now:

• Identify the parties in a clinical trial and name what each is responsible for
• Distinguish a sponsor transferring an activity from an investigator delegating one — and state what neither can hand off
• Locate the coordinating investigator and the lead ethics committee in a multicentre Swiss trial
• Apply the rules for documenting delegation, and spot a delegation log that would fail an inspection
• Decide how much oversight a transferred or delegated activity needs