Quality Assurance In Trials Research Articles

SU-F-T-351: Establishing a Workflow for IMRT Pre-Treatment Reviews for NRG-GY006 Clinical Trial

Purpose: To establish a workflow for NRG-GY006 IMRT pre-treatment reviews, incorporating advanced radiotherapy technologies being evaluated as part of the clinical trial. Methods: Pre-Treatment reviews are required for every IMRT case as part of NRG-GY006 (a randomized phase II trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage I B2, stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer. The pretreatment review process includes structures review and generating an active bone marrow(ABM)- to be used as an avoidance structure during IMRT optimization- and evaluating initial IMRT plan quality using knowledgeengineering based planning (KBP). Institutions will initially submit their simulation CT scan, structures file and PET/CT to IROC QA center for generating ABM. The ABM will be returned to the institution for use in planning. Institutions will then submit an initial IMRT plan for review and will receive information back following implementation of a KBP algorithm, for use in re-optimization, before submitting the final IMRT used for treatment. Results: ABM structure is generated using MIM vista software (Version 6.5, MIM corporation, Inc.). Here, the planning CT and the diagnostic PET/CT are fused and a sub threshold structure is auto segmented above the mean value of the SUV of the bone marrow. The generated ABM were compared with those generated with other software system (e.g. Velocity, Varian) and Dice coefficient (reflects the overlap of structures) ranged between 80 – 90% was achieved. A KBP model was built in Varian Eclipse TPS using the RapidPlan KBP software to perform plan quality assurance. Conclusion: The workflow for IMRT pretreatment reviews has been established. It represents a major improvement of NRG Oncology clinical trial quality assurance and incorporates the latest radiotherapy technologies as part of NCI clinical trials. This project was supported by grants U24CA180803 (IROC), UG1CA189867 (NCORP), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC) from the National Cancer Institute (NCI) and PA CURE grant

The dosimetric impact of target volume delineation variation for cervical cancer radiotherapy

BackgroundCervical cancer inter-observer delineation variation has been demonstrated. This article addresses its dosimetric impact. Methods21 centres outlined two INTERLACE trial quality assurance test cases. A gold standard clinical target volume (GSCTV) was created from a consensus and STAPLE outline. RapidArc plans were created for all centres’ planning target volumes (PTVs; PTV1+2). Gold standard PTVs (GSPTVs) were created for each plan by applying each centre’s CTV–PTV margins to GSCTV. DVH parameters including D95% and Dmean for each PTV1+2 and GSPTV were compared, representing planned versus GSPTV delivered dose. PTV1+2 and GSPTV V95% was also calculated. ResultsReviewing all parameters, no plans achieved acceptable GSPTV coverage. GSPTV V95%⩾95% was not achieved for any plan. GSPTV V95%<90% in 15/21 (case 1) and 14/22 (case 2) and <80% in 2 plans from both cases. GSPTV V95% is on average 10–15% lower than planned and GSPTV D95% is 10–20% lower than planned. Most common GSCTV anatomical areas not receiving 95% dose were vagina, obturator and external iliac nodes and, in case 1, the superior nodal aspect. ConclusionCervical cancer CTV delineation variation leads to significant reductions in dose delivered to GSPTV. This highlights the ongoing importance of standardising delineation in the IMRT era.

Risk Scores to Facilitate Preoperative Prediction of Transfusion and Large Volume Blood Transfusion Associated With Adult Cardiac Surgery

Background The aim of this study was to develop two novel risk prediction scores for transfusion and bleeding that would be used to inform treatment decisions, quality assurance, and clinical trial design in cardiac surgery. Methods Clinical data prospectively collected from 26 UK cardiac surgical centres and a single European centre were used to develop two risk prediction models: one for any red blood cell (RBC) transfusion, and the other for large volume blood transfusion (≥4 RBC units; LVBT), an index of severe blood loss. ‘Complete case' data were available for 24 749 patients. Multiple imputation was used for missing covariate data (typically Results The area under the receiver operating characteristic curve (AUC) was 0.77 (95% confidence interval 0.77–0.77) for the any RBC transfusion score and AUC 0.80 (0.79–0.80) for the LVBT score in the imputed data set. The LVBT model also showed excellent discrimination (Hosmer–Lemeshow P=0.32). In the imputed data set, the AUCs for the TRACK and TRUST scores for any RBC transfusion were 0.71 and 0.71, respectively, and for LVBT the AUC for the BRiSc score was 0.69. Conclusions Two new risk scores for any RBC transfusion or LVBT among cardiac surgery patients have excellent discrimination, and could inform clinical decision making.

Quality assurance metrics in clinical trial conduct.

274 Background: Quality assurance (QA) in clinical trials is a safeguard against non-compliance, which impacts patient safety and data integrity. On an institutional level, compiling quality findings provides insight to gaps within existing processes, protocol compliance, and educational content. A QA metrics methodology has been implemented, which is streamlined with the ICH-GCP, and institutional Standard Operating Procedures (SOPs) and policies. Methods: Individual findings are assigned an alphanumerical code, based on severity and category, and a reference for each Quality Assurance Review (QAR). Annual data is tracked for all QAR findings. Different data sets are created to allow for analysis of quality gaps and quality changes over time. Results are used in the creation or revision of educational content, SOPs, and to drive process improvement. Results: To date, a total of 1608 QAR observations between 2014 and mid-2015 have been coded and tracked across 22 studies. Areas of quality gaps, such as most-cited categories (e.g. 27% in Source Documentation and 13% in Regulatory) and references (e.g. 30% on SOPs and 14% on guidelines), are communicated to the Quality and Education team regularly and incorporated into training content. This has also prompted the development of new SOPs, processes, and research tools, after which QA metrics continues to be used to monitor program wide quality improvement. For example, following the implementation of Electronic Source Documentation, the proportion of findings on delays in Adverse Event sign off has seen a decline. For individual QARs, a personalized trends summary is provided to the study team with an overview of the quality of the study conduct. The report displays the distribution of findings across different categories and severity levels. Lastly, quality metrics has increased the efficiency of tracking and reporting program wide QA activity. Conclusions: The regular analysis of quality metrics has proven to be a pivotal step in the Quality Management Cycle. It presents a quick snap shot of the quality of individual research studies under review. When implemented on an institutional scale, it offers valuable feedback on the current SOPs, processes, and training content.

Quality assurance in MRI breast screening: comparing signal-to-noise ratio in dynamic contrast-enhanced imaging protocols

MRI has been extensively used in breast cancer staging, management and high risk screening. Detection sensitivity is paramount in breast screening, but variations of signal-to-noise ratio (SNR) as a function of position are often overlooked. We propose and demonstrate practical methods to assess spatial SNR variations in dynamic contrast-enhanced (DCE) breast examinations and apply those methods to different protocols and systems.Four different protocols in three different MRI systems (1.5 and 3.0 T) with receiver coils of different design were employed on oil-filled test objects with and without uniformity filters. Twenty 3D datasets were acquired with each protocol; each dataset was acquired in under 60 s, thus complying with current breast DCE guidelines. In addition to the standard SNR calculated on a pixel-by-pixel basis, we propose other regional indices considering the mean and standard deviation of the signal over a small sub-region centred on each pixel. These regional indices include effects of the spatial variation of coil sensitivity and other structured artefacts.The proposed regional SNR indices demonstrate spatial variations in SNR as well as the presence of artefacts and sensitivity variations, which are otherwise difficult to quantify and might be overlooked in a clinical setting. Spatial variations in SNR depend on protocol choice and hardware characteristics. The use of uniformity filters was shown to lead to a rise of SNR values, altering the noise distribution. Correlation between noise in adjacent pixels was associated with data truncation along the phase encoding direction.Methods to characterise spatial SNR variations using regional information were demonstrated, with implications for quality assurance in breast screening and multi-centre trials.

The role of an in-house audit group as an innovative tool to review clinical trials

Background Auditing is an integral part of quality assurance in trials. The introduction of risk-based monitoring in industry coupled with reduced funding for academic trials indicates a need to enhance the comprehensive oversight of trials. Generating an internal audit system streamlines quality management across the clinical trials unit. We aimed to pilot a robust in-house process that prioritises patient safety and monitors trial delivery.

Quality assurance in clinical trials--the role of pathology.

In the last two decades, our knowledge about cancer genetics and cancer biology increased exponentially. Deep sequencing now allows rapid and cost-effective analysis of entire cancer genomes. Dysregulation of cell growth, cell survival, tissue homeostasis, and immune surveillance have been recognized as hallmarks of cancer. In parallel, diagnostic surgical pathology has been harmonized and consensus diagnostic criteria for cancer classification have been developed by initiatives of the World Health Organization, the International Agency for Research on Cancer, and the Union for International Cancer Control. Pharmaceutical companies developed novel drugs targeting specific molecules in signaling pathways, which has allowed the development of the concept of precision medicine. Now, we are facing a large number of clinical trials which bring together these advances and will explore efficacy of novel treatment regimens. Assessment of the efficacy of a new drug is often coupled with the simultaneous assessment of the capacity of tissue-based biomarkers to predict response of individual patients (companion diagnostics/precision medicine). Patients with histologically similar tumors might respond differently to the same drug. This review summarizes the diverse roles played by surgical pathologists involved in clinical trials, with a special focus on quality assurance of diagnostic, laboratory, and reporting standards.

Comparison of investigator-delineated gross tumor volumes and quality assurance in pancreatic cancer: Analysis of the pretrial benchmark case for the SCALOP trial

Background and purposeTo evaluate the variation in investigator-delineated volumes and assess plans from the radiotherapy trial quality assurance (RTTQA) program of SCALOP, a phase II trial in locally advanced pancreatic cancer. Materials and methodsParticipating investigators (n=25) outlined a pre-trial benchmark case as per RT protocol, and the accuracy of investigators’ GTV (iGTV) and PTV (iPTV) was evaluated, against the trials team-defined gold standard GTV (gsGTV) and PTV (gsPTV), using both qualitative and geometric analyses. The median Jaccard Conformity Index (JCI) and Geographical Miss Index (GMI) were calculated. Participating RT centers also submitted a radiotherapy plan for this benchmark case, which was centrally reviewed against protocol-defined constraints. ResultsTwenty-five investigator-defined contours were evaluated. The median JCI and GMI of iGTVs were 0.57 (IQR: 0.51–0.65) and 0.26 (IQR: 0.15–0.40). For iPTVs, these were 0.75 (IQR: 0.71–0.79) and 0.14 (IQR: 0.11–0.22) respectively. Qualitative analysis showed largest variation at the tumor edges and failure to recognize a peri-pancreatic lymph node. There were no major protocol deviations in RT planning, but three minor PTV coverage deviations were identified. . ConclusionsSCALOP demonstrated considerable variation in iGTV delineation. RTTQA workshops and real-time central review of delineations are needed in future trials.

Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. RAVES (Radiation Therapy-Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation and clinician experience.

Technical quality assurance during the TROG 03.04 RADAR prostate radiotherapy trial: are the results reflected in observed toxicity rates?

Multicentre radiotherapy clinical trials can incorporate quality assurance (QA) procedures for ensuring consistent application of the trial protocol in the planning, delivery and reporting of participant treatments. Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy, although little has been shown for toxicity rates. The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial. Using QA records from the TROG 03.04 RADAR trial, the impact of variations on gastrointestinal (GI) and genito-urinary (GU) toxicities was investigated. Protocol variation rates were lower than reported in previous studies, and showed little correlation with GI toxicity outcomes. Variations classified as 'major' showed a non-significant trend for increased toxicity relative to those classified as 'minor'. Results from a Level III phantom-based dosimetry study showed some correlation with GI toxicity, whereas ranking on a set-up accuracy study did not impact on toxicity. Toxicity in general increased with the number of participants accrued per centre, at odds with previous reports relating to disease progression, with a potential link to increases in low-mid-range rectal doses in the cohort from higher-accruing centres. No QA-related variables correlated with GU toxicities. Besides non-significant trends, minimal association was observed between QA variables and toxicity rates for the RADAR trial. The intention of the trial's QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach.

Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs

External proficiency testing programs designed to evaluate the performance of end-point laboratories involved in vaccine and therapeutic clinical trials form an important part of clinical trial quality assurance. Good clinical laboratory practice (GCLP) guidelines recommend both assay validation and proficiency testing for assays being used in clinical trials, and such testing is facilitated by the availability of large numbers of well-characterized test samples. These samples can be distributed to laboratories participating in these programs and allow monitoring of laboratory performance over time and among participating sites when results are obtained with samples derived from a large master set. The leukapheresis procedure provides an ideal way to collect samples from participants that can meet the required number of cells to support these activities. The collection and processing of leukapheresis samples require tight coordination between the clinical and laboratory teams to collect, process, and cryopreserve large number of samples within the established ideal time of ≤8hours. Here, we describe our experience with a leukapheresis cryopreseration program that has been able to preserve the functionality of cellular subsets and that provides the sample numbers necessary to run an external proficiency testing program.

The SCALOP Trial Plan Assessment Form (PAF) as a Tool for Radiation Therapy Trials Quality Assurance (RTTQA)

SCALOP, a randomized Phase II multicenter trial, compared gemcitabine-chemoradiation (CRT) and capecitabine-CRT following induction chemotherapy in locally advanced pancreatic cancer (LAPC); 74 patients were randomized to a CRT arm. A prospective RTTQA program to ensure protocol compliance and high quality RT delivery involved: (1) RT trial protocol including radiologist outlined example images; (2) Centrally reviewed benchmark case for outlining and planning; (3) Real time, on-trial assessment of RT planning compliance for every patient using a trial specific PAF, to allow all planning data to be compared against protocol standards.

Stereotactic ablative radiotherapy in the UK: current status and developments

Stereotactic ablative radiotherapy (SABR) has developed from the principles and techniques used in the stereotactic radiosurgery treatment of brain metastases. Advances in computer technology, imaging, planning and treatment delivery and evidence from retrospective analysis of single- and multi-institutional early-phase studies have established SABR in the treatment of medically inoperable early lung cancer. Effective multidisciplinary team working is crucial to safe delivery of SABR. The variation in patient selection, radiotherapy planning and delivery techniques has led to a collective approach to SABR implementation across the UK. Centres developing the technique are represented in the UK SABR Consortium, which is supported by the relevant UK professional bodies and represents a platform to develop extracranial SABR across the UK. The uptake of SABR in the UK has been slowed by workforce issues, but at least 15 centres are currently delivering treatment with over 500 patients treated using UK SABR Consortium guidance. A mentoring program is being piloted helping new centres to develop their programs, and over 30 UK centres are expected to be offering SABR treatment by the end of 2014. The use of consistent guidance for patient selection, treatment planning and delivery in the UK gives the opportunity to collect and audit toxicity and outcome across the centres, contributing to the internationally reported SABR experience. Having established this service in the UK, the development of SABR through clinical research is a priority, and with input from the Radiotherapy Trials Quality Assurance Group, the UK is developing a national study program that includes participation in international trials.

Dosimetry for audit and clinical trials: challenges and requirements

Many important dosimetry audit networks for radiotherapy have their roots in clinical trial quality assurance (QA). In both scenarios it is essential to test two issues: does the treatment plan conform with the clinical requirements and is the plan a reasonable representation of what is actually delivered to a patient throughout their course of treatment. Part of a sound quality program would be an external audit of these issues with verification of the equivalence of plan and treatment typically referred to as a dosimetry audit. The increasing complexity of radiotherapy planning and delivery makes audits challenging. While verification of absolute dose delivered at a reference point was the standard of external dosimetry audits two decades ago this is often deemed inadequate for verification of treatment approaches such as Intensity Modulated Radiation Therapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT). As such, most dosimetry audit networks have successfully introduced more complex tests of dose delivery using anthropomorphic phantoms that can be imaged, planned and treated as a patient would. The new challenge is to adapt this approach to ever more diversified radiotherapy procedures with image guided/adaptive radiotherapy, motion management and brachytherapy being the focus of current research.

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program.

WE‐G‐141‐01: The Imaging and Radiation Oncology Core (IROC) Group: A Proposed New Clinical Trial Quality Assurance Organization

Purpose: The NCI is implementing the new National Clinical Trial Network (NCTN) Program in 2014 reducing the number of existing study groups from ten to five. The NCTN Program also requires a new combined Imaging and Radiation Oncology Core (IROC) service to provide a uniform QA program. Methods: The six existing clinical trial QA centers, Radiological Physics Center, Quality Assurance Review Center, RTOG QA Center, Image Guided Therapy Center, ACRIN Core Lab and the CALGB Imaging Core Lab have combined to form IROC. The interdependencies between diagnostic imaging and radiation therapy (RT) will be synergized in IROC eliminating duplication of services within the network and optimizing efficient and effective workflows. A major strength of this new organization will be the development of consistent standard operating procedures for all imaging and RT aspects of the NCTN as well as to facilitate a seamless flow of imaging and RT datasets across the network. Results: IROC, administered though the American College of Radiology will provide the scientific and technical expertise in both diagnostic imaging and RT to the entire NCTN Program capitalizing on existing infrastructure and expertise at QA centers currently providing services to the NCI Cooperative Groups. IROC's organizational structure will allow the delivery of a broad array of imaging and RT QA services including Site Qualification; Trial Design Support; Credentialing; Data Management and Case Review. IROC will work closely with the leadership of each Network Group and NCI to assure them that imaging and RT data used by the Groups for protocol analysis are accurate. Conclusion: The proposed IROC Group has hundreds of collective years of experience conducting clinical trial QA and fully understands the QA needs/dataflow requirements of clinical trials to maintain the highest quality clinical trial data that will not obscure the outcomes of clinical trials. This work was supported by PHS grants CA10953, CA21661, CA029511 and CA081647 awarded by NCI, DHHS.

SU‐E‐T‐234: An Automated Tool for Treatment Plan Quality Evaluation and Clinical Trial Quality Assurance

Purpose: Develop an automated plan‐quality evaluation program for multi‐institutional clinical trials to improve case review efficiency. This program is generally applicable to routine clinical process to raise practice quality level. Methods: In this study, we developed an automated plan‐quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. Results: A slight difference of about 0.2% in volume or 0.6Gy in dose between the automated program and manual recording was observed. According to the criteria of indices, there was no significant difference between the two methods. The evaluation time was reduced from 10–20 minutes to 2 minutes by applying the automated plan‐quality evaluation program. Conclusion: Quality review efficiency was much improved by using this automated plan‐quality evaluation tool. Accuracy was also improved as human error was eliminated. This tool will be made freely available to benefit general clinical practice.

Prostate radiotherapy clinical trial quality assurance: How real should real time review be? (A TROG-OCOG Intergroup Project)

Background and purposeReview of plans early in treatment offers the potential to reduce the chance of sub-optimal treatment delivery. We compare the use of real time reviews (RTR) either before randomization (pre-rand 3D RTR) or following randomization (post-rand 2D RTR). Materials and methodsPROFIT is an international randomised trial for men with prostate cancer which had credentialing via multiple dummy runs. In Australia, but not Canada, all plans were submitted for pre-rand 3D RTR using 3D software, and resubmission was requested if significant protocol deviations (PD) were seen. All plans from Canada and Australia then underwent post-rand 2D RTR using a 2D assessment. ResultsFor 147 Australian patients, pre-rand 3D RTR was fast (median 1day, 95% range 0–4days). 51 minor and 5 major PD were observed and 15 of the 147 cases (10%) required resubmission. Of the 5 major PD, 4 were remedied on resubmission and 1 was withdrawn from study. For the post-rand 2D RTR, reports from 147 Australian cases and 193 Canadian cases were reviewed. No major PD were reported from Australian cases, but 3 were seen in Canadian cases (0% versus 1.5%; p=0.26). There was also no difference in the rate of minor PD (14.3% versus 15.3%; p=NS). ConclusionsIn a study using relatively simple treatment volumes after comprehensive credentialing, pre-rand 3D RTR offers only modest benefits compared with post-rand 2D RTR. In the future the intensity of RTR may need to vary according to protocol and site specific factors.

Improving radiotherapy quality assurance in clinical trials: assessment of target volume delineation of the pre-accrual benchmark case.

As the complexity of radiotherapy (RT) trials increases, issues surrounding target volume delineation will become more important. Some form of outlining assessment prior to trial entry is increasingly being mandated in UK RT trials. This document produced by the Outlining and Imaging Subgroup (OISG) of the National Cancer Research Institute will address methods to reduce interobserver variation in clinical trials and how to conduct an assessment of outlining through a pre-accrual benchmark case. We review currently available methods of describing the variation and identify areas where further work is needed. The OISG would encourage ongoing discussion with chief investigators in order to provide advice on individual aspects of benchmark case assessment for current and future trials.

Development of a novel treatment planning test for credentialing rotational intensity-modulated radiotherapy techniques in the UK

The increasing use of tomotherapy and volumetric-modulated arc therapy in UK centres will result in more centres choosing to use this technology in a clinical trial setting. The Radiotherapy Trials Quality Assurance (RTTQA) group has developed a new procedure to integrate into the UK intensity-modulated radiotherapy (IMRT) credentialing programme to cover rotational IMRT delivery techniques. A planning test [three-dimensional treatment planning system (3DTPS)] was designed specifically for rotational IMRT techniques. The feasibility of using this test in the credentialing programme for rotational IMRT was validated by 10 experienced UK centres. The study included five centres using Varian RapidArc™ (RA) (Varian Medical Systems, Milpitas, CA), two using Elekta VMAT™ (VMAT) (Elekta Inc., Norcross, GA) and three using helical tomotherapy (HT) plans. Centres were asked to carry out their own in-house quality assurance (QA) for the plans submitted for this study. A survey was sent out to centres aiming to gather information on their experience in undertaking the exercise and their QA results. All centres fulfilled the primary goal by achieving the dose constraints of the primary planning target volume and organ at risk. Seven centres (three RA, one VMAT and three HT plans) were able to fulfil the secondary goal. Among those seven centres, three centres (two RA and one VMAT plans) achieved the tertiary goal. The results of the survey indicated that the 3DTPS test is a clinically relevant and practical planning test to be used. A planning test for rotational therapy techniques was developed for the RTTQA IMRT credentialing programme. This study validated the feasibility of a 3DTPS test to be used as part of a credentialing programme for rotational IMRT techniques in the UK.