Volume LVII, Number 1
Jennifer Harry
Seattle Children’s Research Institute
Ethan Arana
Laird Norton Wetherby
Marilyn Marshall
Helios, Research Administrative Services
Abstract
This case study evaluates Seattle Children’s Research Institute’s self-audit process of 11 private industry-funded clinical trials, with a specific focus on post-award financial management. Our primary goal was to evaluate the effectiveness of newly implemented systems and processes designed to mitigate financial and compliance risks to the organization. This comprehensive review of our existing practices, including document integrity, identified areas for improvement and opportunities for increased training initiatives. The study highlights the importance of continuous training for research administrators, focusing on adapting to new systems and policy changes. Findings will be disseminated to senior leadership to inform future recommendations, guide institutional improvements, and champion financial stewardship in clinical trial research management. Lessons learned will also be shared internally and externally to benefit the broader research community.
Keywords: Clinical Research, Post-Award, Compliance, Research Operations, and Contracts
Introduction
While clinical trials are essential to translational research, their management can offer complexities that may be unfamiliar to many research administrators. This often creates a significant training gap, which can expose institutions to considerable financial and billing compliance risks. Unlike other areas of research administration, clinical trial management involves unique intricacies, particularly within the pre-clinical and clinical research stages of the translational research spectrum (National Center for Advancing Translational Sciences, n.d.). This poses two major risks: 1) having a lack of experience managing clinical trial studies can become a financial risk to the respective institution, and 2) having a lack of experience can become a billing compliance risk to the respective institution. A core function of research administrators managing clinical trials is to prevent study deficits through consistent invoicing, timely and complete reconciliations, and accurate charge routing based on the study coverage analysis to the appropriate funding source.
Research administrators frequently discuss financial statuses and deficits with research study teams or the Principal Investigator (PI), leading to a common question: how can I avoid a clinical trial deficit while adhering to complex compliance rules and contract terms? Effective management of clinical trials, from coverage analysis and budget negotiation to comprehensive post-award processes, is crucial to preventing financial loss upon trial completion. As Lievre notes, “[m]any trials are stopped early because…funding does not match the incurring costs” (Lièvre et al., 2001, p.603). To avoid this mishap, “…something to consider is how to monitor the budget during the trial. Monitoring the budget throughout the trial can create financial stability throughout the trial’s longevity” (Fritter & Harper, 2023, p.1).
Coverage analysis is a vital part of compliant clinical research billing and involves identifying all clinical items and/or services and assigning financial responsibility to the clinical trial sponsor, patient, or a third-party insurer. This process requires a detailed review of study documents to determine the Medicare billing status, ensuring adherence to federal regulations (Table 1). Non-compliance can result in substantial fines from the U.S. Department of Justice and public scrutiny. With over half a million clinical trials registered on ClinicalTrials.gov as of June 2025, the potential for mismanagement to create high-risk environments is significant (National Library of Medicine, n.d.).
Table 1. Compliance in Clinical Research Billing Following Federal Billing Requirements*
Centers for Medicare & Medicaid Services (CMS, n.d.) provides a National Coverage Determination policy on Routine Costs in Clinical Trials which outlines federal regulations for any clinical trial receiving Medicare coverage of routine costs. Failing to adhere to this policy can lead to organizational fines and large settlement payouts. The False Claims Act prohibits knowingly submitting false claims to the government for reimbursement; “double-dipping” (billing both sponsor and insurance for the same services) is a common example. The Office of Public Affairs recently published the settlements and judgments under the False Claims Act, exceeding more than $2.9 billion in fiscal year 2024, the highest in any one fiscal year (U.S. Department of Justice, 2025).
Seattle Children's Research Institute (SCRI) continues to excel as one of the top five pediatric research centers, which fosters an academic environment supporting multidisciplinary research. Seattle Children’s Hospital serves as the pediatric and adolescent academic medical center for the WAMI region (Washington, Alaska, Montana, and Idaho)—the largest region of any children’s hospital in the country (Seattle Children’s, 2024). As Varmaghani et al. notes, industry sponsored clinical trials are not only beneficial for the “advancement of healthcare and science,” but they have positive effects on the society’s economy including the “…significant investment of pharmaceutical companies in supporting [clinical trials] for the development of healthcare and science and economic growth of countries is undeniable” (Varmaghani et al., 2020, p.1194).
Serving a robust pediatric population, SCRI manages over 500 active studies, including both federally and industry-sponsored clinical trials. SCRI has implemented many initiatives to boost transparency, communication, and fiscal accountability within research administration. Support comes from the various Center Business Office (CBO) Research Centers and the Clinical Research Support Office (CRSO), assisting PIs with private industry-sponsored clinical trials—the focus of this case study.
Given the risks of clinical trial mismanagement, institutions need to ensure staff are properly trained in post-award financial management. SCRI’s Center for Clinical & Translational Research CBO took a proactive, risk-averse strategy by conducting a self-audit on several clinical trials. This self-audit aimed to confirm continued compliance with regulations and best practices, identify knowledge gaps, and refine existing business processes. Over the past three years, SCRI has also faced major changes, including adopting a new Clinical Trial Management System (CTMS), centralizing clinical trial support, and aligning with evolving strategic initiatives. The goal of this self-audit was to gauge understanding of these new changes, identify areas for new and ongoing training for our research administrators, and offer recommendations to leadership for continuous improvement in clinical research management and operations.
The main goal of our self-audit incorporates ideas and processes from the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation—Transforming the Economics of Clinical Trials, including to:
…consider approaches to enable business transformation that will keep pace with new technology and the escalating need for information about the practice of medicine, it would be wise to first articulate a common goal for the clinical research enterprise: to facilitate the efficient conduct of high-quality clinical trials to address pressing medical questions and evaluate therapeutic interventions. This goal serves both public health and business interests. In short, we want to do more trials at a lower cost, complete them faster, and enhance their quality (Kramer & Schulman, 2012, p.186).
Case Presentation
For our case study at SCRI, 11 clinical trials were selected, which were all fully pharmaceutical and biotech private industry-sponsored and funded. The clinical trials had study start dates from the beginning of early 2017 to current ongoing trials. Studies were selected across various PIs, divisions, sponsors, study designs, Contract Research Organizations, and the responsible Grants and Contracts Administrator (GCA) for post-award financial management (see Table 2 for additional details).
Table 2. Clinical Trials Selected for Self-Audit
Since implementing our CTMS in 2023, some of the selected studies predated software implementation, some were legacy back build studies used in the CTMS to troubleshoot and learn system capabilities quickly, and some were newer studies completely built out and managed using the CTMS. It must be noted that the CTMS is new to SCRI, and studies older than two years may not have been fully built out in the system due to its recent implementation. Of the clinical trials reviewed, seven of our 11 trials were not fully built into the CTMS. Four of the trials selected had transferred over time to another internal PI, which created multiple financial accounts to reconcile throughout the full clinical trial conducted. Three of the selected trials included mixed billing, where research-related study costs are billed to both the sponsor and the patient’s insurance. For studies with mixed billing, our Electronic Health Record (EHR) was used to validate unique participant visits to ensure proper charge routing of clinical billable procedures and services.
The main goal of this self-audit was to ensure that changes implemented in recent years were continually improving institutional processes and procedures for better management of our clinical trials conducted at SCRI. As Fritter and Harper (2023, p.1) state, “It is important to conduct financial audits because it provides a comparison of your total revenue to your total expenses. There is the ability to notice…what was budgeted and if the trial is over or under budget,” for example. In the past five years, like many research institutions, SCRI has implemented numerous software systems and updated processes to streamline, automate, and improve daily research administration operations. This self-audit allowed observation of the impact of those changes over time, as well as identification of gaps in the current oversight of clinical trial post-award management, as institutional knowledge continued increasing and new training opportunities developed.
To standardize the process, a list of documents for each study was established for review, and their availability was documented. Documents reviewed included final protocols, final consent forms, final billing grids (BG), fully executed clinical trial agreements (CTA), fully executed clinical trial amendments, reconciliation and study financial projection files, CTMS invoicing reports, CTMS subject study visit reports, EHR billing reports, and accounts receivable (AR) reports.
The final study protocol served as a reference to verify study-related procedures and activities as stated in the schedule of events. If a final consent was not obtained, a draft version was used. This was used to harmonize participant incentive payments with posted participant expenditures. At SCRI, the final BG includes the completed coverage analysis agreed upon during negotiations between the private industry entity and SCRI by CRSO upon review of the final study protocol. This was used to reconcile research charges as well as determine billing designations. The fully executed CTA was used to verify payment terms and invoiceable items per study. Revenue was reconciled against the payment schedule and invoiceable items set out in the terms and conditions. If the clinical trial included any CTA amendments, these were collected to reconcile any protocol changes that would represent a financial change in payment collection from the sponsor. Reconciliation and study financial projection files were collected from each of the GCAs managing the selected studies. AR reports were further collected for each study to verify revenue received and help identify any missing payments to study accounts. Files were reviewed and audited, and recommendations were provided if any information was found missing.
For studies entered into CTMS, invoicing reports were generated and reviewed to ensure that invoicing had occurred based on patient enrollment and study-related activities. Additionally, deidentified participant visit information from CTMS subject study visit reports was further collected to reconcile against the coverage analysis to ensure patient activity was billed correctly and that revenue was captured for completed study visits. Specific research-related reports in the EHR were previously created for this self-audit case study for the CBO to review, reconcile, and verify that each medical billing transaction was routed appropriately based on the coverage analysis.
In this self-audit case study, invoicing reports were generated and reviewed to ensure that invoicing had occurred based on patient enrollment and study-related activities for studies that were entered into our CTMS. Deidentified participant visit information was further collected to reconcile against the above-mentioned coverage analysis to ensure patient activity was billed correctly and that revenue was captured for completed study visits.
In our self-audit, we assessed whether the listed documents were available or unavailable for the selected clinical trials (see Table 3). “When acquiring the documents, …[i]f these are scattered and in multiple formats, it may prompt the need to develop a better storage format for future audits” (Fritter, 2023, p.2). This fortunately only occurred with a few of our older clinical trials that were self-audited, and it primarily concerned final consent/assent documents. To effectively manage clinical trials, it is important that there is a source of truth. With the recent implementation of the CTMS, a recommendation has since been provided to our CRSO to help standardize the location of study-related documents so that documents are easily accessible by the study team and GCAs. “Electronic storage systems or financial tracking systems are the most efficient way to maintain data integrity throughout a clinical research study” (Fritter, 2023, p.2).
Table 3. Materials Found
Once all relevant clinical trial administrative documents were gathered, each trial’s history to date was reviewed. This process began with a detailed expenditure report from SCRI’s institutional financial software systems that itemized all account detailed expenditures life-to-date for the clinical trial. If a study had a change in PI over time, detailed expenditure reports of all associated accounts over the course of the study were included. This report was used as a reference to compare actual expenditures to the original estimated expenses budgeted in the final BG developed during coverage analysis. Financial reports were downloaded to Excel to create searchable filters for comparison purposes. This was used to compare each participant and their study visits with other study participants in the reviewed clinical trial. From there, the original study billing grid was cross-compared to verify whether the trial’s actual expenses were within an acceptable variance of the amounts estimated in the study billing grid.
PI and staff labor expenditures were similarly compared to the final BG, as were clinical procedures. Actual expenses were reviewed against estimated budgets to determine variances causing potential overages in study team labor expenses. Before study start-up, the study team met with CRSO analysts to determine the estimated time per PI, per clinical research coordinator, and whether the study plans to utilize a core resource such as a clinical research coordinator labor pool. These time estimates were used in budget negotiations with the industry sponsor when developing the CTA. Based on the fully negotiated estimates, when a study visit had occurred, the date of the participant’s study visit was cross-compared to labor expenses at the same time for the PI and/or other study staff. Variances were noted, especially if hours did not align with a participant’s visit or the labor expenses were greater than the approved study final BG.
In addition, the most updated account reconciliation file by the assigned GCA for each clinical trial was reviewed to see if study visits outlined in the BG were being reconciled thoroughly based on our current standard business processes. Study payments received were matched to amounts corresponding to the latest CTA. Additionally, study procedures, regulatory, and other invoiceable items were reviewed to assess if they were submitted to the sponsor and if done so in a timely manner (for example, within 30-60 days of visit completion). After invoices had been submitted to sponsors, we reviewed whether payments were followed up on in agreement with payment terms in the CTA. In addition, we reviewed whether payments were received and applied to the study account within a 30–60 day timeframe after the completion of each visit.
For studies that had mixed billing, EHR patient billing reports were utilized to track clinical billable procedures when a clinical trial involved billing to both the private industry study sponsor and a patient’s insurance for certain allowable standard of care procedures. This was done to ensure that there were no instances of double-billing. The self-audit revealed no instances of this occurring, and we were able to utilize some of the studies reviewed to guide group discussions and increase shared knowledge among GCAs of best practices when encountering these types of clinical trials. Another key finding was that our actual expenditures for clinical billable procedures had minimal variances from the coverage analysis originally developed. At SCRI, the more recent clinical trials were built completely in our CTMS. These studies had easily accessible reports allowing us to view upcoming planned study visits, past visits, and corresponding study invoicing. Additionally, our CTMS provided study accrual reports to verify clinical trial participants. When available, these additional reports easily helped cross-compare multiple sources of data when reviewing each clinical trial’s financial expenditures during our self-audit.
Self-Audit Process
The self-audit conducted at SCRI consisted of the following process steps. We first collected all necessary administrative documents outlined in Table 3. Next, a detailed life-to-date financial expenditure report was created using filtered, searchable fields in Microsoft Excel. After this, we identified participant ID numbers on our financial reports, associating expenditures with each participant ID, and cross-referenced financial transaction dates to participants’ visit dates. This allowed for our self-audit purposes to search by participant visit, clinical billable procedure, or other non-personnel study-related expenditures to identify noticeable trends, variances, or other inconsistencies. To quantify personnel expenses by amount and effort spent, we used financial labor reports to detail study time expensed for PI and associated clinical research staff time.
We set up a shared OneDrive folder to review the case clinical trials to confirm and double-check findings. Each shared folder contained each trial’s study documents, financial data, and summary results specific to each clinical trial to be discussed during the follow-up meeting with GCAs. Regarding Protected Health Information, all files were deidentified of participants' names (if found), and clinical trial subject identification numbers were used to ensure patient confidentiality during our review. In addition to eliminating any identification, all study short title names, PI names, sponsor names, and other identifying information were removed when discussing the clinical trials selected in our self-audit.
It was also important to have easily available for reference or cross-comparison the final BG developed in the coverage analysis process, GCA’s latest account reconciliation and projection files, EHR clinical billing reports, and CTMS reports (when available). Variances and inconsistencies were noted when found per the clinical trial study. We drilled down in our available reports to compare CPT codes used in coverage analysis for developing the study BG to CPT codes used in our EHR for participant visit encounters to account for clinical procedures mandated by the study protocol. This included a careful review of any clinical procedures possibly bundled together with multiple CPT codes (such as Anesthesia with Imaging). With the information gathered, we compared clinical billable visit-related expenditures to corresponding sponsor visit payments per the current terms and conditions of the CTA. The financial self-audit reviewed all automatic sponsor-paid visits, and it further reviewed outstanding invoiceable items included in the CTA to compare with incoming study AR payments. Additionally, we compared participant visits across the clinical trial for consistency among all study participants.
Once the initial review was completed, study findings were confirmed in a summary report for each self-audited clinical trial to be discussed with the assigned GCA. These reports detailed the information available for the self-audit of materials listed in Table 3 to ensure that the GCA agreed with the available or missing documents. Additionally, the summary findings listed questions for clarification to be discussed during the meetings specific to the study. These questions typically pertained to ongoing administrative tasks such as corresponding with the clinical research coordinators for any specific questions related to visit procedures, following up on outstanding sponsor payments, or creating new invoices to ensure we have the most updated trial information when reviewing each study. Finally, this report summarized any noted findings or future directions the GCA planned to undertake in the overall findings section. Each summary report was approximately one page, resembling a high-level executive summary overview that outlined the history of the trial to date and any pending tasks or lessons learned from the self-audit. Some of the older trials audited were conducted prior to new institutional processes and procedures, and many had turnover of GCA administration during the time of the coronavirus pandemic. The intention of this meeting with the GCA was to inform and improve future processes rather than a punitive measure.
We also included notes at the bottom of the final summary reports documentation summarizing the follow-up GCA meeting discussion and any relevant feedback. For our self-audit, we offered each study GCA time to respond to any findings or additional information requested after the meeting concluded, with an expected turnaround time of less than a week. After the meeting, we emailed documents of our findings to each GCA and their supervisor for record keeping, noted findings, and next steps if needed.
Then we cross-compared relevant findings across all examined cases to look for consistently applied institutional policies and procedures, adherence to accounting and clinical trial standards, and identify areas of impact and room for further improvement. Each study summary report was rolled up into an overall self-audit executive report for CBO administrative leadership to review and analyze for future decision-making purposes. These summary findings clearly illustrated to departmental leadership that a previously identified problem with administrative management of clinical trials, which had been addressed through institutional process improvements, was no longer occurring with post-award management of more current clinical trials. The information generated from our self-audit of just a small selection of our CBO clinical trials allowed departmental administrative leadership the ability to review information gathered to develop strategic business process recommendations for next steps.
Discussion
Spotlight Case: Study 3
Study 3 exemplifies how effective clinical trial management and target training can positively impact an organization in a short period. For the self-audit of Study 3, this clinical trial faced a significant deficit when initially reviewed in late 2023, primarily due to a lack of comprehensive GCA management preceding this period. This challenge is common among clinical trials, and the objective was to improve the GCA’s fundamental understanding of this clinical trial and to establish effective management strategies moving forward, as the study was ongoing. Due to GCA turnover, an interim GCA with clinical trial management experience was assigned to review the trial in late 2023. A new permanent GCA, with prior experience mainly in federally funded research administration but no clinical trial experience, was hired in early March 2024 (see orange dotted line in Figure 1). The interim GCA provided training to the new hire during their first 90-day onboarding window, from March through the end of May 2024. After the 90-day onboarding window (see grey dotted line in Figure 1), the interim GCA no longer oversaw or performed any administrative tasks related to this clinical trial.
Figure 1. Study 3 Deficit Trend
The initial training period for the new hire commenced in March 2024 for Study 3. Within the subsequent six months, the overall study deficit was reduced significantly, resulting in a positive balance for ongoing study expenditures. During the 90-day onboarding window, the new hire was trained to use our CTMS and follow institutional standard processes and procedures for effectively managing clinical trials at SCRI. They also frequently engaged in one-on-one training sessions with the interim GCA, specifically discussing this case study trial and other trials in their new research portfolio. For Study 3, the primary cause of the existing deficit was identified as inconsistent invoicing to the study sponsor by the prior GCA managing the clinical trial. Identifying items not yet invoiced but reimbursable by the sponsor, as per the CTA, became the most significant factor for increasing the study’s revenue and reducing the study deficit. Invoiceable items identified primarily fell into areas of regulatory compliance (monitoring visits, IRB modifications, IRB annual continuing review, etc.), identified screen failures, and reimbursement of participant travel expenses for their study visits.
Given the volume of items to be invoiced, the interim GCA suggested grouping items into “buckets” for submission to the sponsor for ease of payment processing. This approach facilitated quicker verification by the sponsor, therefore decreasing payment processing times. The first invoice created identified potential screen failures, and all participant information was first verified with the clinical research coordinator at the site to validate invoicing details. The clinical research coordinator confirmed four screen failures to be invoiced. This invoice alone represented 16.27% of revenue generation during the six months after the permanent GCA was hired (see Figure 2). This also served as an effective training exercise for engaging with the study teams to identify potential screen failures for a study. The second invoice was related to regulatory compliance, representing 10.45% of revenue generation during the time discussed. Third, an invoice was created for all participant travel reimbursements to date. Upon review, an amendment was found fully executed in January 2021 to include reimbursement for participants traveling outside the immediate Seattle area, covering items such as flights, lodging, meals, mileage, and other visit-related travel expenses. The invoice for travel reimbursement accounted for 23.93% of revenue generation during this time. The remainder of revenue generated during this period originated from ongoing participant visit payments (21.74%) and the identification of invoiceable study procedures (27.61%). The newly hired and trained GCA also routinely contacted the sponsor during this time to address any related follow-up questions, ensuring prompt payment processing to the institution.
Figure 2. Study 3 Revenue Collection March - September 2024
Figures 1 and 2 illustrate the substantial positive impact of concentrated invoicing efforts on significant deficit reduction in less than half a year. From October 2023 to September 2024, this clinical trial account decreased from a -$97,727 deficit to an available balance of $18,637 to continue ongoing study activities. This demonstrated the benefit of effective clinical trial management and the resulting positive impact that can be trained and replicated with other ongoing clinical trials across the department and institution. Furthermore, the self-audit of these selected clinical trials facilitates institution-wide knowledge sharing for best practices in future business policies and procedures related to effective post-award financial and administrative clinical trial management.
Spotlight Case: Study 9
Study 9 highlights another common cause of deficits during clinical trials post-award management: misaligned labor expenses. For this clinical trial, the outlined self-audit process was applied. Findings indicated that all invoicing was kept updated regularly, and the study had received sponsor payments promptly. However, the historical study deficit persisted. During the follow-up discussion with the GCA, it was identified that the study team was continuously charging labor expenses for study recruitment efforts without additional revenue due to a lack of enrollment. The original PI-approved billing grid did not include reimbursement for recruitment expenses. This discrepancy was identified, and it caused a finding in the self-audit, as reconciliation of the charged labor expenses with the amount of labor allocated for completed participant study visits was not possible. This issue was discussed with the GCA, their supervisor, and past PI budget meeting discussion materials were reviewed. Although the GCA had previously identified the cause of this deficit to the study team, the clinical research coordinator continued to post labor hours not reimbursable by the CTA. This was also communicated to the PI, indicating their responsibility for any outstanding deficits at the conclusion of the clinical trial, as they had already provided approval of the negotiated CTA and related BG developed during coverage analysis. Additional recommendations were made to the study team to request a possible future amendment, as well as request reimbursement for recruitment activities for any future clinical trials with hard-to-recruit patient populations.
Participant recruitment activities can be especially time-consuming for pediatric clinical trials or trials studying rare diseases. “Recruiting…within the defined time frame in clinical trials has proven to be the chief bottleneck in the drug development process. It causes missed clinical trial deadlines, leads to increased costs, and consumes more time than any other aspect...” (Chaudhari et al., 2020, p.64). While not every sponsor is open to accepting this study expense during CTA negotiation, many recognize the time and effort needed to support ongoing study recruitment and retention of participants.
To enhance departmental business processes for deficit mitigation, several proactive steps were recommended and implemented. To increase visibility, our Grants and Contracts Coordinators (GCCs) at SCRI now provide CBO administrative leadership with ongoing monthly deficit reports that detail clinical trial accounts by PI, study, and deficit amount. These reports are also sent to the GCAs, requiring input on whether the deficit is true or if pending revenue is anticipated to resolve the deficit amount within a reasonable time frame. Typically, a minor deficit in an ongoing clinical trial is considered an acceptable study financial variance, as there is often a delay between when a participant visit occurs and the time payment is received from the sponsor. This would serve as an example of an acceptable deficit justification. For true deficits, a 3-tier Deficit Mitigation Plan has been recommended for leadership to help guide discussions and ideally reverse any known deficits. The three tiers are structured into threshold limits of up to $5k, over $5k, and over $10k for escalation purposes and to guide discussions to address and hopefully reverse any known deficits (see Figure 3). For each threshold step, specific meetings are held for discussion purposes to proactively prevent deficits from further increasing. GCCs assist in coordinating these meetings, as well as maintaining documentation of ongoing discussion, escalation steps, and remedial actions taken.
Using the formalized steps outlined, the goal is to proactively address ongoing deficits as quickly as possible, thereby lessening financial liability to SCRI. When deficits remain unaddressed or corrective actions are not taken, they can often create a snowball effect, increasing the deficit further over time. The Deficit Mitigation Plan aims to curtail this snowball effect and address potential long-term study deficits as soon as identified as problematic.
Figure 3. Deficit Mitigation Plan
Conclusion
This case study, involving a self-audit of 11 selected clinical trials at SCRI, demonstrates that with ongoing training initiatives focused on effective clinical trial management, best practices can significantly improve financial outcomes in a short timeframe. Through concentrated efforts over a brief period, the institution successfully improved the financial standing of challenging cases and identified key areas for sustained improvement in post-award financial clinical trial management. The finding that more recent clinical trials showed less variance in charge matching, attributable to centralized negotiation and budget development, further highlights the positive impact of strategic institutional initiatives. A recent article showcasing Ohio State University and Nationwide Children’s Hospital saw similar success when they implemented their audit process, which contributed to returns of more than hundreds of thousands of dollars (Fritter, 2023).
To further build on these successes and address identified areas for growth, SCRI should implement a robust, ongoing training program for all GCAs. This training program must emphasize proficiency with the newly adopted CTMS, ensuring that all GCAs can fully utilize its capabilities for accurate invoicing, payment tracking, and reporting. Furthermore, training should continuously adapt to evolving institutional policies and external regulatory updates, consistent with best practices across the diverse clinical trial portfolio. For instance, specific training could focus on complex mixed-billing scenarios, reconciliation techniques, and optimizing sponsor communication for timely payment resolution.
Additionally, a tiered deficit mitigation protocol should be formally integrated into routine financial oversight. This would involve proactive, structured reviews at specific financial thresholds, such as the proposed 3-tier Deficit Mitigation Plan levels of up to $5k, over $5k, and over $10k. At each level, accountability measures and discussions would occur, involving relevant stakeholders from GCAs to administrative leadership. The goal of this structured approach is to ensure immediate financial shortcomings and prompt implementation of corrective actions, thereby preventing escalating into significant financial liabilities. This proactive approach will not only protect the institution but also empower the GCAs with clear guidelines and support for managing complex financial challenges.
These strategic recommendations, along with continued centralization of clinical budget development and negotiation, will further enhance financial stewardship and compliance across the institution’s diverse clinical research portfolio. By expanding these strategies to other clinical trial studies across the department and the institution, SCRI can contribute to positively impacting its organizational financial stability and overall efficiency in managing clinical trial operations (Fritter, 2023). This proactive approach ensures that the institution remains financially robust and compliant, fostering a sustainable environment for future clinical research endeavors.
Overall lessons learned from our self-audit included recognizing the added value of our newly implemented CTMS, which has enhanced overall study transparency and streamlined the invoicing process. In SCRI’s first full fiscal year of utilizing our CTMS, we exceeded expectations in our goal to increase clinical trial invoicing through our training and institutional transformation initiatives. Our department in the CBO with the case study clinical trials selected witnessed a six-fold increase in invoicing for ongoing active clinical trials using our CTMS, solidifying its use to continue managing our growing number of trials and to continue increasing related revenue collection.
Moving forward, we look to strengthen our partnerships with other peer departments and center support service areas in our institution to encourage self-auditing as a continuous process improvement initiative across our organization. We plan to incorporate ideas and processes from the Journal of Clinical and Translational Science:
This means incorporating hands-on activities that are designed to promote peer-to-peer inter-institutional networking, sharing of best practices and experiences, and discussion of new approaches or affirming current approaches. Activities support the presented content by enabling participants to engage with the material through case studies, real- world examples, and simulated scenarios (Roth et al., 2024, p.2).
Our CRSO and Research Integration Hub have outlined upcoming initiatives, including closeout scorecards and updated feasibility assessments and processes. Other strategic goals include centralizing clinical trial invoicing to increase revenue collection and streamlining the budget negotiation process. Small strategic investments like these enhance our ability to conduct high-quality clinical trials at our institution. Building upon this momentum, we also want to further develop leadership training initiatives for supervisors to better oversee and guide their direct reports in effective post-award clinical trial management practices, helping to flourish and support clinical research initiatives at our institution. Continuing SCRI’s internship program with the University of Washington to create a translational workforce pipeline of incoming research administrators is crucial to continuing and sustaining effective post-award management of our organization’s clinical trials.
In summary, our self-audit results spotlight the need for ongoing training and professional development opportunities, standardized processes, and cross-departmental collaboration to foster an environment supportive of effective clinical trial management. To support our institution’s mission of patients first and to conduct cutting-edge research, we need to invest in our workforce and create a supportive environment where clinical trial research administrators can train, learn, grow, and excel in their roles. Research administration is not a profession that is widely advertised and often overlooked in educational pathways. By creating career pathways and educational opportunities in new areas of research administration, we can continue to retain and grow new talent conducive to providing effective clinical trial management.
Author's Note
This manuscript reflects the original work of Jennifer Harry, Ethan Arana, and Marilyn Marshall. All authors participated in conceptualizing the work, reviewing the literature, analyzing relevant data, and shaping the final narrative. Each author reviewed and approved the final version of the manuscript and agrees to be accountable for the accuracy and integrity of the work. This manuscript reflects our independent scholarly perspectives and does not represent the official views of our affiliated institutions. No external funding influenced the development of this work, and the authors report no conflicts of interest. We extend our appreciation to colleagues and mentors who provided thoughtful feedback during the drafting process, as well as to the broader clinical research community whose ongoing contributions continue to inform and inspire our work.
Jennifer Harry
Director, Center Business Operations
Seattle Children’s Research Institute
1920 Terry Ave
Seattle, WA 98101
Jennifer.harry@seattlechildrens.org
Ethan Arana
Seattle Children's Research Institute (former Intern)
Laird Norton Wetherby (current Client Associate)
ethanarana10@gmail.com
Marilyn Marshall
Founding Consultant
Helios, Research Administrative Services
PO Box 1370
Ocean Park, WA 98640
marshallmarilyn@outlook.com
Corresponding Authors: Correspondence regarding this article should be addressed to Jennifer Harry (Jennifer.harry@seattlechildrens.org) and Marilyn Marshall (marshallmarilyn@outlook.com).
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