Qualified Investigators Research Articles

Systematic review-based guideline "Parkinson's disease" of the German Society of Neurology: diagnostic use of transcranial sonography.

Transcranial brain parenchyma sonography (TCS) has been recommended as a tool for the early and differential diagnosis of Parkinson's disease (PD) in German and European clinical guidelines. Still, the brain structures to be examined for the diagnostic questions and the requirements for being a qualified investigator were not specified in detail. These issues have now been addressed in the 2023 update of the clinical guideline on PD by the German Society of Neurology (DGN). The recommendations were based on a systematic literature review following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Three diagnostic questions were defined: (1) What is the accuracy of TCS in the differential diagnosis of PD versus atypical and secondary Parkinsonian syndromes? (2) What is the accuracy of TCS in the differential diagnosis of PD versus essential tremor? (3) What is the accuracy of TCS in the diagnosis of PD in persons with typical early symptoms, compared with the diagnosis established by clinical follow-up? The brain structures to be assessed and the level of recommendation were formulated for these questions. The training requirements for being regarded as qualified TCS investigator were stipulated by the responsible medical societies (German Society of Ultrasound in Medicine, DEGUM; German Society for Clinical Neurophysiology and Functional Imaging, DGKN). Finally, the recommendations for these diagnostic questions reached strong consensus (each ≥ 97%) of the guideline committee. Here, the details of review and recommendations are presented. The updated guideline clarifies the diagnostic uses and limitations of TCS in PD.

IT-INVESTIGATOR IN THE DIGITAL ENVIRONMENT OF CRIMINAL PROCEEDINGS

This paper is devoted to the issues of investigation of crimes characterized by complexity and extensive use of digital technologies. The authors argue that criminal proceedings nowadays need modernization through the involvement of technology, as well as the provision of highly qualified investigators who are able to use the knowledge of interdisciplinary sciences to solve technogenic problems of criminal proceedings. Many crimes are committed with the use of modern technologies. At the same time, crimes are becoming more and more sophisticated and technological. They can be investigated by IT-investigators. It seems that the level of competence of the latter can be determined by the category of crimes, defined by the method of committing crimes. Highly qualified investigators should also investigate crimes related to digital financial assets and digital currency. The authors substantiate that an IT investigator should be able to work with big data, read expert opinions on the results of computer-technical examinations of any complexity, widely use electronic documents, and in the future use an electronic assistant. Digital video library, audio recordings and photos can be accumulated in cloud spaces, regarding which today there are various proposals for the application of software, modeling, algorithmization of processes.

Large vessel occlusive stroke with milder baseline severity shows better collaterals and reduced harm from thrombectomy transfer delays.

Patients with large vessel occlusion (LVO) stroke presenting with milder baseline clinical severity are common and require endovascular thrombectomy. However, such patients are difficult to recognize using pre-hospital severity-based triage tools and therefore are likely to require a secondary inter-hospital transfer if transported to a non-thrombectomy center. Given the potential for milder severity to represent better underlying cerebrovascular collateral circulation, it is unknown whether transfer delays are still associated with poorer post-stroke outcomes in this patient group. We primarily aimed to examine whether the harmful effect of inter-hospital transfer delay for thrombectomy was different for LVO patients with mild or severe deficits. Secondarily, we also investigated whether imaging markers of collateral circulation were different between severity groups. Registry data from two large Australian thrombectomy centers were used to identify all directly presenting and secondarily transferred LVO patients undergoing thrombectomy, divided into those with lower (NIHSS < 10) and higher (NIHSS ⩾ 10) baseline deficits. The primary outcome was the functional independence or return to baseline defined as modified Rankin Scale 0-2 or baseline at 90 days. Patients with complete baseline CT-perfusion data were analyzed for imaging markers of collateral circulation by baseline severity group. A total of 1210 LVO patients undergoing thrombectomy were included, of which 273 (22.6%) had lower baseline severity. Despite similar thrombolysis and recanalization rates, transferred patients had lower odds of achieving the primary outcome compared to the primary presentation to a thrombectomy center, where baseline severity was higher (adjusted odds ratio (aOR) 0.759 (95% CI 0.576-0.999)), but not when severity was lower (aOR 1.357 (95% CI 0.764-2.409), p-interaction = 0.122). In the imaging analysis of 436 patients, those with milder severity showed smaller median ischemic core volumes (12.6 (IQR 0.0-17.9) vs 27.5 (IQR 6.5-37.1) mL, p < 0.001)), higher median perfusion mismatch ratio (10.8 (IQR 4.8-54.5) vs 6.6 (IQR 3.5-16.5), p < 0.001), and lower median hypoperfusion intensity ratio (0.25 (IQR 0.18-0.38) vs 0.40 (IQR 0.22-0.57), p < 0.001). Patients receiving secondary inter-hospital transfer for thrombectomy had poorer outcomes compared to those presenting directly to a thrombectomy center if baseline deficits were severe, but this difference was not observed when baseline deficits were milder. This result may potentially be due to our secondary findings of significantly improved collateral circulation markers in lower-severity LVO patients. As such, failure of pre-hospital screening tools to detect lower-severity LVO patients for pre-hospital bypass to a thrombectomy center may not necessarily deleteriously affect outcome. Anonymized data not published within this article will be made available on request from any qualified investigator.

Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study

IntroductionCognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or...

Clinical characteristics and outcome in expansive compared with steno-occlusive mural hematoma in spontaneous cervical artery dissection.

Spontaneous cervical artery dissection (sCeAD) is one of the prime causes of ischemic stroke in young adults. Based on vessel wall imaging, steno-occlusive or expansive wall hematomas can be distinguished. It is unclear whether these two distinct morphological phenotypes reflect different pathophysiological processes. We aim to evaluate differences in clinical characteristics and long-term recurrence between patients with expansive and steno-occlusive mural wall hematoma in the acute phase. Participants of the ReSect-study, one of the largest single-center cohort studies with long-term follow-up of sCeAD patients, with sufficient magnetic resonance imaging (MRI) were included. All available MRI scans were retrospectively evaluated for patients dichotomized to two groups: (1) mural hematoma causing steno-occlusive pathologies without expansion of total vessel diameter (steno-occlusive hematoma), and (2) mural hematoma causing vessel diameter expansion without lumen stenosis (expansive hematoma). Patients with mixed steno-occlusive and expansive vessel pathologies were excluded from the analysis. In total, 221 individuals were available for analysis. The pathognomonic vessel wall hematoma was steno-occlusive in 187 (84.6%) and expansive in 34 (15.4%). No difference was seen in patient demographics, clinical status at admission, laboratory parameters, family history, or the frequency of clinical stigmata for connective tissue disorders. Both patients with expansive and steno-occlusive mural hematoma had a high likelihood of suffering cerebral ischemia (64.7 vs 79.7). Still, time from symptom onset to diagnosis was significantly longer in those with expansive dissection (17.8 vs 7.8 days, p = 0.02). Those with expansive dissections were more likely to have upper respiratory infection within 4 weeks prior to dissection (26.5% vs 12.3%, p = 0.03). Upon follow-up, functional outcome was identical and groups did not differ in rate of sCeAD recurrence, but those with expansive mural hematoma at baseline more frequently had residual aneurysmal formation (41.2% vs 11.5%, p < 0.01). As cerebral ischemia was frequent in both, our clinical results do not advise for differential treatment or follow-up based on the acute morphological phenotype. There was no clear evidence of a different aetiopathogenesis between patients with steno-occlusive or expansive mural hematoma in the acute phase. More mechanistic approaches are needed to elucidate potential differences in pathomechanism between both entities. Anonymized data not published within this article will be made available by request from any qualified investigator.

Decline in spontaneous cervical artery dissection incidence during COVID-19 public health measures: Evidence for a role of upper respiratory infections in pathogenesis.

Upper respiratory infections have been suggested as a risk factor for spontaneous cervical artery dissection (sCeAD). If this is the case, public health measures implemented to contain the spread of SARS-CoV-2, which also reduced other communicable diseases such as influenza, might be associated with a reduction in cervical artery dissection incidence. We determined the incidence of sCeAD before, during and after the COVID-19 pandemic, and the associated public health measures. All patients suffering an sCeAD and seen in Innsbruck Austria, between January 2002 to December 2016 (pre-COVID comparators) and between January 2020 to August 2022 were recorded through two individual prospective cohort studies. We compared admission rates, demographic, and clinical characteristics of sCeAD patients in pre-COVID-19 and COVID-19 times. In total, 249 sCeAD patients were admitted prior to the COVID-19 pandemic compared to 20 during its course. Baseline characteristics of sCeAD subjects did not differ in subjects admitted during and prior to the pandemic. Following the introduction of public health measures for the pandemic, there was a marked decrease of sCeAD admissions from 16.5 per year to 6.3 per year (p = 0.012). Since the measures were ended the number of sCeAD admissions increased again. In contrast, the number of all ischemic stroke patients treated at the Medical University of Innsbruck did not alter during the pandemic. (N per year: 633 in 2015, 687 in 2017, 684 in 2019, 731 in 2020, and 717 in 2021). The incidence of sCeAD fell markedly during the pandemic and this may have resulted from the public health measures introduced and a subsequent reduction in upper respiratory infections. Our study provides indirect evidence for a role of infection in the pathogenesis of sCeAD. Anonymized data not published within this article will be made available by request from any qualified investigator.

Preparing clinicians to be site investigators in multicenter clinical trials: A training program at an academic medical center.

Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators.

The Institute on Methods and Protocols for Advancement of Clinical Trials for ADRD (IMPACT‐AD): An update after two years of conduct.

AbstractBackgroundWe developed the Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT‐AD) to address the shortage of qualified investigators with adequate training and expertise to conduct Alzheimer’s Disease (AD) and AD Related Dementias (ADRD) clinical trials.MethodWe describe the experience of the first two years of funding of the IMPACT‐AD course, specifically the rates of applications to the course, descriptive summaries of the accepted trainees, and the measures of participant satisfaction and learning.ResultOver the first two years of the course, we received 195 eligible applications to the course. Most (n = 121, 62%) applicants were female and nearly half self‐reported as being African American/Black, Asian, or Pacific Islander race and/or Hispanic/Latino ethnicity. Forty‐one applicants (21%) indicated that they were the first in their family to attend collegeOf 69 total trainees accepted to the course (36% acceptance rate), a majority (n = 44, 64%) were female. Twenty‐eight (41%) self‐reported as being African American/Black, Asian, or Pacific Islander race and eleven (16%) were of Hispanic ethnicity. Fourteen trainees (20%) identified as being the first person in their family to attend college. Among trainees, 24 (35%) were MDs, 30 (43%) were PhDs, and 9 (13%) held master’s degrees.Course lecture topics were rated, on average, as “essential” or “valuable” by 98% of trainees. Across lecture topics, on average, 48% of trainees rated their prior knowledge of topics as “very strong” or “strong,” and 11% of trainees rated their prior knowledge as “weak.” Overall, 52% of trainees evaluated their change in knowledge based on the lectures as “very much increased,” 46% as “somewhat” or “slightly” increased, and 2% as “no change.” Results were similar for the two tracks. Based on pre‐ and post‐course assessments, trainees improved their knowledge of covered content (from 62% to 79% correct responses on knowledge assessments).ConclusionThe IMPACT‐AD course is achieving its mission of educating and diversifying the next generation of ADRD trialists.We thank Dr. Laurie Ryan and Dr. Kristina McLinden from the National Institute on Aging for their key contributions in leadership and scientific guidance of IMPACT‐AD.

Preparation of single-cell suspensions from the human placenta.

Single-cell RNA-sequencing (scRNA-seq) allows the characterization of cellular composition and interactions in complex tissues. An essential prerequisite for scRNA-seq is the preparation of high-quality single-cell suspensions. So far, no protocols have been described for preparing such suspensions from the placenta, an essential organ for fetal development and a site of maternal-fetal immune interaction. Here we describe a protocol for the preparation of high-quality single-cell suspensions from human placental tissues-namely, the basal plate, placental villi and chorioamniotic membranes. The protocol outlines the collection of tissues from the placenta, tailored dissociation procedures for each tissue, and the cryopreservation of single-cell suspensions for multiplex sequencing library preparation. The protocol can be performed by a qualified investigator with basic working knowledge of placental structure. Moreover, the single-cell suspensions generated by using this protocol are compatible with droplet-based scRNA-seq technology, such as the 10x Genomics Chromium system. This protocol reliably produces single-cell suspensions from the placental tissues with high yield and viability for scRNA-seq. This protocol takes ~6 h to complete from tissue collection to cryopreservation of single-cell suspensions, and an additional 2 h for thawing of cryopreserved single cells.

Factors associated with the location of perivascular space enlargement in middle-aged individuals undergoing brain screening in Japan

ObjectiveIn elderly populations, the enlargement of the perivascular space is related to small vessel disease and the glymphatic system. Enlarged perivascular spaces (EPVS) in the basal ganglia (EPVS–BG) and EPVS in the centrum semiovale (EPVS–CSO) are associated with different pathophysiological processes. However, the prevalence of EPVS and the factors associated with EPVS location in healthy middle-aged individuals are still unclear. We aimed to determine the prevalence of EPVS and the factors associated with EPVS location among healthy individuals in their 40 s MethodsThis study included 5000 consecutive healthy individuals who underwent screening for brain diseases in Japan from August to December 2018. Of them, the data of individuals in their 40 s were extracted and analyzed. The associations of age, sex, body mass index, smoking and drinking history, and medical history with EPVS location were investigated. Similar analyses were performed for the other age groups. A literature review on the factors associated with EPVS location was also performed. ResultsA total of 1720 individuals in their 40 s were finally included. The prevalence of EPVS–BG and EPVS–CSO was 7.7% and 9.2%, respectively. Age (years), smoking history, and hypertension were associated with EPVS–BG; none of the studied factors were found to be associated with EPVS–CSO. In the elderly, the factors previously reported to be associated with EPVS–BG included atherosclerosis change, while the factors associated with EPVS–CSO were cerebral amyloid angiopathy-related formation. ConclusionBoth EPVS–BG and EPVS–CSO occurred among healthy individuals in their 40 s, but they did so rarely, and less prevalently than in older age groups. EPVS–BG and EPVS–CSO may represent early imaging signs of the atherosclerotic and cerebral amyloid angiopathy processes, respectively. Data AvailabilityThe anonymized data for this study will be shared upon any qualified investigator’s request to the corresponding author. Primary data from this study will be made available upon reasonable request in accordance with the review board of the research institute.

Abstracts from the NIH Office of Research on Women's Health 2022 Annual BIRCWH Meeting:Building Interdisciplinary Research Careers in Women's Health November 2, 2022

Abstracts from the NIH Office of Research on Women's Health 2022 Annual BIRCWH Meeting:Building Interdisciplinary Research Careers in Women's Health November 2, 2022

A guide for developing a field research safety manual that explicitly considers risks for marginalized identities in the sciences

Abstract Field research can be an important component of the career trajectories for researchers in numerous academic fields; however, conducting research in field settings poses risks to health and safety, and researchers from marginalized groups often face greater risks than those experienced by other researchers in their fields; If these additional risks are not actively and thoughtfully mitigated, they are likely to hinder the participation of qualified investigators in field research and counteract efforts to improve and promote diversity, equity and inclusion in the field sciences. Here we provide, from our perspectives as co‐authors of a field safety manual for the Department of Biological Sciences at the University of Pittsburgh in Pennsylvania, United States, (A) background on risks and barriers that should be considered when planning and conducting field research and (B) suggestions on how to work as a collaborative team for developing an inclusive field safety manual. As an example of a manual this proposed process has yielded, we have included our own field safety manual written with diversity, equity and inclusion as a central focus. We hope this publication serves as a starting point for those interested in developing a similar document for use in their laboratory group, department or institution.

Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss

IntroductionThis protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss...

Geometric Derivation of Camera Equations

&lt;div class="section abstract"&gt;&lt;div class="htmlview paragraph"&gt;Photogrammetry, camera matching, and model-based image matching are commonly used techniques to analyze photographs and video for accident reconstruction and other forensic applications. Investigators are often tasked with taking measurements from photographs or determining speed from a video. All such calculations are based on fundamental geometric principles governing image projection inside a camera. Most treatments in the literature express the image projection equations in matrix notation rather than closed-form solutions. The purpose of this paper is to present a geometric derivation of the image projection equations in closed form that can be readily applied by a qualified investigator without the need for specialized software. In addition, a simple brute force optimization procedure is described to perform camera matching and model-based image matching. Examples are provided to demonstrate the method.&lt;/div&gt;&lt;/div&gt;

Prevalence and Risk of Obstructive Sleep Apnea and Association with Orofacial Symptoms in Patients Attending the Dental Clinics.

Background:Dentists have a vital role in detection of the signs and symptoms of obstructive sleep apnea (OSA) as it modifies in anatomy of orofacial structures.Aims and Objectives:This study aims to assess the prevalence of OSA risk in patients attending dental department and explore the factors related with high-risk OSA.Materials and Methods:The study was carried in the Al-Farabi Dental College, Jeddah, Saudi Arabia, on 200 consecutive dental patients from June 1, 2018, to July 31, 2019. Demographic details and the OSA risk were evaluated based on the Berlin questionnaire (Arabic version). Two qualified investigators independently did anthropometric measurements, medical and dental examination.Results:About 3.7% of males and 13.8% of females were found to be at high risk of OSA. Obese individuals almost had twice more likely chance to have OSA symptoms.Conclusion:Our findings confirm that dentists have an important role in recognizing the OSA signs and symptoms.

Геоморфология и неотектоника Восточной Сибири. К столетию со дня рождения А. Г. Золотарева

Doctor of Geography, Professor Anatoly Gavrilovich Zolotarev (02.18.1921– 01.15.2011) takes a worthy place in the history of Siberian science and Irkutsk State University. He was a bright and, we can say, unique personality, combining the qualities of a recognized leader, a talented organizer of science and higher university education, a brilliant lecturer and teacher, and, finally, a geologist – a highly qualified investigator. The area of his scientific interests was the geomorphology of Eastern Siberia, the latest tectonics of the Siberian platform and pre-rift transition zones of Eastern Siberia. He examined in detail the stages and features of the formation and structure of the Baikal-Patom step-vaulted uplift, as well as the latest tectonics and geomorphological structure of the Khubsugul region. He developed corrections for calculating the total amplitudes of vertical neotectonic movements – for the initial level, given the fluctuations of the World Ocean and corrections for the lithomorphic level. The result of these studies was the conclusion about the subsidence of some parts of the Siberian platform, and not their uplift, as previously thought. These new data were taken into account when compiling maps of the latest tectonics of the south of Eastern Siberia on a scale of 1: 1,500,000 under the guidance of A.G. Zolotarev. Zolotarev created a powerful Siberian scientific and educational geomorphological school, distinguished by high efficiency both in the field of fundamental and applied geomorphology, and in the training of specialists in geomorphology.

Low rates of restenosis in primary lateral carotid artery endarterectomy

Carotid artery endarterectomy (CAE) is a treatment of choice for symptomatic and asymptomatic high-grade carotid stenosis, showing great results in reducing stroke morbidity. The optimal technique of the arterial closure is, however, still under discussion, with both patch angioplasty and primary closure having numerous advantages and pitfalls. The definite evidence is still lacking. The aim of this study was to evaluate the results of the modified primary closure technique during CEA. Incidence of restenosis more than 8 months after the surgery was measured. A retrospective observational study to evaluate modified primary internal carotid artery closure was conducted in Republican Vilnius University Hospital from January 1st, 2014 to December 31st, 2018. The patients were enrolled in the trial during their routine follow-up by their surgeon. During the visit, after an informed consent was signed, a qualified investigator performed carotid duplex ultrasound scan, documenting the restenosis rates. Patients also filled in the comorbidity assessment questionnaire, which included their smoking habits, history of hypertension and their adherence to antihypertensive medication as well as cholesterol levels and statin therapy, additional related comorbidities. Out of 342 patients that underwent CAE with primary closure in the Republican Vilnius university hospital from 2014 to 2018, 42 patients were identified as deceased, therefore a follow-up was impossible. Out of planned 150 (50%) consequently selected patients, 125 gave an informed consent to be enrolled into the study. Out of those 6 pre-occlusions were established during the review of the patient medical data and therefore were excluded from the study. In general, we analyzed the data of 119 patients and 125 CAE with a modified primary suture closure. The mean follow-up time was 35.78 months (SE 0.992; SD 11,046). At the time of a follow up, 3 (2,4%) carotid artery occlusions were identified and promptly evaluated. Restenosis rates varied: 5,6% of patients had low grade (&lt;50%), 5,6% had moderate grade (50-69%) and 1,6% had high grade (70-99%) stenosis. The modified lateral CAE with primary closure technique, used in our hospital’s contemporary practice has shown to be a promising alternative to the classical primary suture, due to reduced restenosis rates. More prospective and randomized studies are needed to evaluate this technique in comparison to other CAE closure techniques.

Effectiveness of telerehabilitation in physical therapy: A protocol for an overview in a time when rapid responses are needed.

Rehabilitation and physical therapy have been adapting to the telehealth era, increasing accessibility and improving the continuity of attention in geographically remote populations with disabilities. Due to the spread of infection by SARS-CoV-2, many professionals have had to adapt their work to telerehabilitation practices, which require the best evidence at short notice and in summarized form. In this context, this protocol has been developed to evaluate the effectiveness of telerehabilitation as a care strategy in physical therapy for different conditions, populations, and contexts. An overview will be carried out in the format of a rapid review. It will include systematic reviews of different conditions, populations, and contexts, where the intervention to be evaluated is telerehabilitation by physical therapy. The outcomes considered will be clinical effectiveness depending on the specific condition, functionality, quality of life, satisfaction, adherence, and safety. A search will be carried out of the MEDLINE/PubMed, EMBASE, and Cochrane Library databases. Studies will be selected in duplicate with any discrepancies resolved by a third reviewer. Data extraction and risk of bias assessment will be carried out by a reviewer with non-independent verification by a second reviewer. The findings will be reported qualitatively by tables and figures. The principles of the value of the research question, the methodological rigor, scientifically qualified investigators, an independent evaluation of the protocol, and timely and accurate publication of the results will be complied with. The complete review will lead to the publication of at least one article, and the results will be widely disseminated at various levels of decision-making. This protocol has been registered in PROSPERO with the number CRD42020185640.

Anti-NMDA receptor encephalitis presenting as new onset refractory status epilepticus in COVID-19

• Autoimmune encephalitis and status epilepticus in COVID-19 can be challenging. • Immunotherapy could be useful for anti-NMDAr encephalitis and SARS-Cov-2 infection. • Cytokines storm could play a role for NORSE presentation in NDMA-R encephalitis.

Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard “one-size-fits-all” GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of preparedness and qualification of investigators and delegates, determining whether a site team is a good fit for a particular protocol, and improving the quality of clinical trial conduct.