Clinical Researcher—February 2026 (Volume 40, Issue 1)
ON THE JOB
Elizabeth Weeks-Rowe, LVN, CCRA
Patient safety, credible data, and investigator responsibilities have their origins in the Declaration of Helsinki and are the tenets of ethical research conduct. Patient safety is supported by sound trial design, early-phase trials that help identify optimal dosing, and consistent adverse event review/reporting by investigators. Credible data starts with accuracy in data collection and documentation. It is refined by adherence to the ALCOA++ principles for data integrity, and collated/reported through electronic data capture, with each generation reassessed to reach the most credible stage.
Principal investigator (PI) responsibilities are outlined in section 9 of the Form FDA 1572 (Statement of Investigator) and the Good Clinical Practice guideline from the International Council for Harmonization, which help ensure such elements of investigator compliance as:
- Adherence to the protocol
- Proper conduct of informed consent
- Institutional review board (IRB) compliance
- Accurate record keeping and reporting
- Training and oversight of investigational site staff, vendors, and ancillary support staff
Patient safety, credible data, and the investigator’s responsibilities are equally important, but the investigator’s responsibilities are the most actionable, and help drive patient safety and credible data. They are also best facilitated by strong, professional relationships between investigators and other members of the clinical trials team.
Investigator-related relationships are diverse across the trial spectrum, and include sponsor–investigator relationships, clinical research associate–clinical research coordinator relationships, and investigator–site staff relationships. The sponsor communicates study directives to trusted investigators knowing they will be effectively understood and implemented. Investigators then disseminate protocol requirements to appropriately trained/qualified staff. Those qualified staff complete study procedures, collect and report credible data, and work collectively with the investigator to ensure that IRB compliance, PI oversight, and patient safety are maintained. These relationships are symbiotic; the success or failure of one significantly impacts the other and, ultimately, trial performance.
Further, these relationships are not defined by regulatory standards nor quantified by an algorithm. They are not a footnote reference in a scientific journal nor housed in a repository. They are formed in the proverbial trenches by clinical researchers executing on both sides of the equation (site and sponsor). They must be intentional, carefully cultivated, and nurtured for sustainability. They must be collaborative, not subordinate. They must be rooted in transparency and reliability. They start with the obvious why but culminate with the critical how. How are directives communicated? How are questions answered? How are promises delivered? How is each side supported?
A Perspective from the Field: Part I
Trevor J. Cole, BHS, MBA-HCM-PM, CCRC, PMP, RN, Program Director at WCG, has worked on the sponsor and investigational site side in his 13 years as a clinical researcher, intrinsic to his understanding of factors that help or hinder investigator relationships. He notes that “a strong relationship can make the world of difference when collaborating as sites and sponsors, and the adage [about] ‘leave the place better than you found it’ is exactly the mindset we should bring to every partnership, ensuring our collaboration leaves the other party stronger, more capable, and better supported than before. When relationships are intentionally cultivated, communication becomes more open, trust deepens, and operational efficiencies follow.”
Cole cites the 2025 WCG CenterWatch Global Site Relationship Survey Report, which shows that overall site satisfaction continues to decline, with total customer satisfaction scores for long‑standing attributes dropping below 70% for the first time and study coordinators consistently reporting lower satisfaction than investigators. Quality communication remains one of the most important attributes to sites rated as “very important” by 74% of respondents; underscoring a simple truth of the saying: clear is kind, and unclear is unkind.
Spelling Out the Six Rs
There are six elements (we can think of them as the “six Rs”) that set the standard for successful investigator-related relationships and drive fulfilment of investigator responsibilities: recognition/respect, responsiveness/rigor, resolution, and return.
Recognition/Respect
This starts at the inception of a sponsor–site relationship. The sponsor recognizes potential study sites that seem qualified to recruit and execute study deliverables. This is accomplished through a transparent feasibility process that provides current protocol information and rigor in study site communication.
Investigational sites recognize trial potential and should thoroughly consider all study elements against site capabilities before agreeing to site evaluation. Respect is gained when all sponsor–site variables are weighed for a sound decision on participation. Better a study be declined with an honest assessment than the loss of revenue and respect that follows inflated abilities and disguised deficits (on both sides).
Responsiveness/Rigor
Communication must be transparent, professional, and timely. Sponsors should provide study information/updates as they occur and impact such areas as patient safety/data/investigator responsibilities, newly discovered side effects presented in an investigator’s brochure and informed consent release, and extra blood tests or eligibility criteria that place additional burden on sites and participants. They must follow those communications with timely responsiveness to sites, prioritizing seeking and providing clarity to questions asked and rigor in follow-up to issues identified.
On the other side, investigators/site staff must provide feedback on sponsor directives that impact their ability to retain participants and execute study timelines. They must speak up during investigator meetings on what is presented in theory (protocol design) that may not be possible to implement at the site level. They must ask critical questions during site initiation visits and pursue answers until they come. They must question that which does not seem right during monitoring visits and provide that essential insight.
Truth in information enables the equitability that is key to fostering effective relationships. Rigor and responsiveness lend credibility to and strengthen relationships over the long haul.
Resolution
Problems are presented with vigor but may lose their momentum on the path to resolution. There are often two causes: lack of movement and lack of solutions. There must be a single point of contact on the site and sponsor side when dealing with corrective and preventative action items that result from monitoring visits, central data, or safety listings review. The point of contact should employ follow-up at specific intervals to ensure that the items identified and solutions proposed don’t get lost in the ether.
Corrective and preventative action must be two-tiered, identifying issues and presenting solutions. It is simple enough to identify a discrepancy and walk away. However, when the individual identifying the issue also provides workable solutions and remains open minded to feedback, all parties are given a voice and resolution is achieved faster.
Return
Don’t just show up—keep showing up. During critical times, everybody must show up. But once the fire goes out and the deliverable is met, interest wanes. The way to sustain a successful relationship is to stay consistently available and aware, no matter the circumstance. Whether times are boring or boisterous, investigator-related relationships are bolstered by consistency and availability.
A Perspective from the Field: Part II
Cole also notes the challenges of, and the means toward, fostering consistent behaviors to strengthen investigator relationships and responsibilities. “Strengthening site–sponsor relationships requires moving beyond intent to consistent, observable behaviors that reinforce alignment and shared accountability,” he observes. “The [WCG] survey highlights meaningful gaps in areas that directly affect adherence to responsibilities, including protocol feasibility, incorporation of site feedback, contract and budget flexibility, and the growing burden of technology platforms; all of which declined in performance from 2023 to 2025. Addressing these challenges starts with earlier and more authentic site engagement, especially during protocol design, clearer escalation pathways, and proactive communication around timelines, expectations, and changes.
“Equally important is recognizing the operational reality of site teams—particularly study coordinators—by simplifying technology, ensuring training is practical, and following through on commitments. When sponsors invest in clarity, responsiveness, and partnership—and not just oversight—they create the conditions for stronger relationships, better compliance with responsibilities, and, ultimately, more sustainable clinical research execution.”
Elizabeth Weeks-Rowe, LVN, CCRA, has broad experience as a clinical research consultant, trainer, site evaluation and selection expert, content creator, and conference presenter. She is the author of The CRA’s Guide to Monitoring Research. Based in California, she last wrote for Clinical Researcher in February 2025 about “Critical Assimilation Tools to Aid the Training of New Clinical Researchers.”
