Clinical Research: What Does the Physician Actually Do?

Q: Where Does an SMO Fit In?

A Site Management Organization (SMO) provides operational support to physicians and medical practices conducting clinical trials.

kcastagnaro7

Jul 15

5 min read

One of the first questions physicians considering clinical research ask is also one of the most practical:

How much of my time is this going to take?

It’s a fair question.

Clinical trials involve protocols, regulatory requirements, patient visits, documentation, sponsor communications, data entry, monitoring visits, and numerous other activities that don't exist in ordinary clinical practice.

But the physician serving as Principal Investigator (PI) does not personally perform every task required to run a clinical trial.

A well-supported research site divides responsibilities among the investigator and a research team. Understanding that division is one of the best ways to determine whether clinical research could realistically fit into your practice.

What Is the Physician's Role in a Clinical Trial?

The Principal Investigator is the physician responsible for the conduct of the clinical trial at the research site.

That responsibility is significant.

The PI provides medical and research oversight and is responsible for ensuring that the study is conducted appropriately, participants are protected, and the research team follows the study protocol and applicable requirements.

But responsibility doesn't mean doing everything yourself.

Many of the operational tasks involved in running a study can be performed by trained research professionals working under appropriate investigator oversight.

Think of the PI as the clinical and research leader of the site—not its research coordinator, regulatory specialist, data-entry person, scheduler, and billing department all rolled into one.

What Does the Physician Actually Do?

The exact responsibilities vary by study, but a physician investigator can generally expect to be involved in several important areas.

Evaluate the Study Before Agreeing to Participate

Before accepting a clinical trial, the physician should understand what is being studied and determine whether participation makes sense for the practice and its patients.

That means reviewing the protocol and considering questions such as: Are these patients we actually see? Is the study scientifically and clinically appropriate? Can we realistically follow the protocol? Are there procedures or requirements that could create problems for our patients or practice?

This is an important decision. A study shouldn't be accepted simply because it's available.

Complete Study-Specific Training

Before a trial begins, investigators typically complete required training on the protocol and other study-specific requirements.

Depending on the study, additional training may be required during the trial, particularly when the protocol or other study documents change.

Your research team can help coordinate and track these requirements, but some training must be completed by the investigator.

Determine Whether Patients Are Appropriate for the Study

Research staff can help identify potential participants, review eligibility criteria, gather records, coordinate screening activities, and prepare information for physician review.

But medical eligibility often requires investigator judgment.

The physician remains an important part of determining whether participation is medically appropriate for an individual patient.

Provide Medical Oversight

Some study activities specifically require physician involvement.

Depending on the protocol, this could include physical examinations, assessment of adverse events, review of laboratory or imaging results, treatment decisions, evaluation of symptoms, medication decisions, or other clinical assessments.

The specifics depend heavily on the trial.

Oversee the Research Team

A PI can delegate many study tasks to appropriately qualified members of the research team.

But delegation isn't the same as giving away responsibility.

The investigator needs to know who is performing study activities, ensure that individuals are appropriately qualified and trained, and provide adequate oversight throughout the trial.

That is why having an experienced research team matters.

What Doesn't the Physician Usually Have to Do Personally?

This is where physicians new to research are often pleasantly surprised.

There is a substantial amount of work involved in conducting a clinical trial, but much of it can be handled by research professionals.

Depending on the arrangement and the particular study, a research team may manage activities such as:

Coordinating study startup and activation
Preparing and maintaining regulatory documentation
Coordinating Institutional Review Board (IRB) submissions
Scheduling research visits
Preparing for patient visits
Tracking study procedures and timelines
Communicating with sponsors and Clinical Research Organizations (CROs)
Entering data into study systems
Responding to data queries
Maintaining research records
Preparing for sponsor monitoring visits
Managing investigational product processes
Tracking study-related payments and invoices
Coordinating study closeout

Some studies require additional specialized support, and the exact division of responsibilities will vary.

The key point is that a physician doesn't need to personally become a clinical research operations expert in order to become an investigator.

How Much Time Does Clinical Research Require From the Physician?

There isn't one answer.

A straightforward observational study may require relatively little physician time. A complex interventional trial with frequent visits, treatment decisions, safety assessments, or specialized procedures may require considerably more.

Enrollment matters too. A study with one active participant creates a different workload than a study with 20.

This is one reason evaluating a clinical trial before accepting it is so important.

A research team should be able to help the physician understand the anticipated workload, visit schedule, required investigator activities, patient population, and operational complexity before the practice commits to the study.

The right question isn't simply:

"How many hours will this take?"

It's:

"Which responsibilities require me, and which responsibilities will my research team handle?"

Will Clinical Research Disrupt My Medical Practice?

It shouldn't be allowed to.

Research adds new activities to a medical practice, and those activities need to be deliberately integrated into existing clinical operations.

Patient scheduling, examination rooms, research staff, laboratory services, investigational product storage, documentation, and communication all have to work within the practice environment.

That's one reason trying to "add research" without adequate infrastructure can become frustrating quickly.

A well-designed research program should work around the clinical practice—not expect the clinical practice to reorganize itself around research.

For physicians who don't want to build that infrastructure internally, working with an experienced research organization can provide another option.

Where Does an SMO Fit In?

A Site Management Organization (SMO) provides operational support to physicians and medical practices conducting clinical trials.

The exact services vary among organizations, but an SMO may provide clinical research coordinators, regulatory support, study startup assistance, data management, sponsor communication, research systems, financial administration, quality support, and other research infrastructure.

The physician remains the investigator.

The SMO provides much of the machinery that helps the research site operate.

That distinction matters.

A good research partner shouldn't try to take the physician out of clinical research. It should take unnecessary research administration off the physician's plate so the physician can concentrate on patients, medical decisions, and investigator oversight.

What If I've Never Been a Principal Investigator Before?

That's okay.

Every experienced investigator had a first clinical trial.

The more important questions are whether you're interested in research, have the appropriate medical expertise, have access to a relevant patient population, are willing to fulfill the responsibilities of an investigator, and have the right support around you.

You don't have to know how to build a regulatory binder, navigate every sponsor system, prepare for a monitoring visit, or manage a clinical trial budget before exploring the possibility.

Those are learnable—and supportable—parts of clinical research.

Your medical expertise is the part that can't simply be supplied by a research operations team.

Interested in Clinical Research but Concerned About the Workload?

Altitude Clinical Research works with physicians and medical practices that want to participate in clinical trials without building an entire research operation themselves.

We provide research infrastructure and operational support while the physician remains focused on the responsibilities that require their medical expertise and investigator oversight.