We are promoting and educating research to realize world-class research.
It plays a role as an ARO (Academic Research Organization) as well as a promotion axis for university-wide research projects, and covers a wide range of projects from research support to education in collaboration with medical faculties / graduate schools and affiliated hospitals. We are doing activities.
Consulting on clinical research (including doctor-led clinical trials)
For on-campus researchers: Free support in principle
Under the "Ethical Guidelines for Medical Research for Humans" enforced from April 2015 and the "Clinical Research Law" enforced from April 2018, further scientificity and ethics for conducting clinical research Is required. Therefore, it is necessary to proceed with the plan while looking at the overall schedule, such as the formulation of research plans and the establishment of an implementation system, with an eye on goals such as acquisition of public research funds, acceptance of papers, and regulatory approval. By thinking with TARC about the direction of the idea in the faculty's mind, we aim to create a protocol together to prove the true endpoint of the idea. We will build a strategic partnership so that you can say, "The meeting with TARC has clarified the logic of research." We look forward to your active consultation from the "research idea" stage.
Research strategy consultation Clarification of test hypothesis Setting up a test design to test the hypothesis Examination of test feasibility
Statistical consultation Statistical analysis does not cost if it is only consultation. However, it is not possible to actually carry out statistical analysis at the consultation site. Please bring the following materials with you when you consult with us.
Clinical trial protocol or overview An overview of the data to be imaged (image of talble1 in the paper, basic statistics sheet for main variables) Test hypothesis and what kind of analysis you want to do Results of analysis conducted by yourself so far
In principle, the actual statistical consultation will be conducted through an interview.
About consulting reservation
Reservations are accepted by email. Please fill in (1) name, (2) affiliation, (3) email address, (4) extension number, (5) desired date and time, (6) name of the principal investigator or instructor, (7) email address of the principal investigator or instructor, and please contact tarc-info@med.teikyo . Depending on the content of the consultation, we will respond by email or face-to-face. If you would like to meet, please indicate multiple candidate dates and times. We also accept consultations at web conferences, so if you wish, please indicate so in the email. Please cooperate with a simple questionnaire after the consultation.
Clinical research (including doctor-led clinical trials) support services
Available for both on-campus and off-campus researchers: Partially paid
The Teikyo Academic Research Center (TARC) supports a wide range of trials, from single-center clinical trials to nationwide multicenter clinical trials, clinical research, doctor-led clinical trials and clinical trials, from planning to operation and management. doing. In addition to research planned and operated by researchers belonging to this university, we also support a wide range of research support requests and research outsourcing from off-campus educational / research institutions, medical institutions, pharmaceutical companies, medical device manufacturing companies, etc. If you would like to support clinical research, please feel free to contact TARC.
< Details of support operations >
Contents
Overview
1. Creating a research plan (protocol)
Research design
Case number design
Protocol creation support, etc.
(Doctor-led clinical trial) Support for prior interviews and face-to-face advice with PMDA
2. Building a research system
Budget estimation / allocation, etc.
Negotiations with sponsors
Estimate negotiation for clinical research insurance, procedure support
Management office / data center maintenance
3. Support for various in-hospital procedures before the start of the test
Ethical review, conflict of interest, etc.
4. Data management
Construction and management of electronic case data collection system (EDC)
Creating a data management plan
Registration / allocation
Data management
Data review
5. Monitoring
Planning a monitoring plan according to research risk
Promotion and implementation of specific clinical research activities
At Teikyo University, "We have established a "procedure manual for conducting clinical research under the Clinical Research Law," and are promoting and implementing specific clinical research activities for on-campus researchers. TARC prepares for specific clinical research in this clinical research activity. We provide operational support.
Educational activities and information dissemination related to clinical research
At TARC, we are engaged in various activities to develop a wide range of human resources involved in clinical research, and to provide continuous educational support and information dissemination.
1. Management of clinical research course at Graduate School Graduate School of Medicine
Research activities related to clinical research methods
At TARC, we not only support the clinical research of researchers, but also the staff themselves are enthusiastically conducting various researches as research subjects. The specific research areas are as follows.
Database research using electronic medical records
Epidemiological research on occupational health in the workplace (telework research, etc.)
Clinical studies on the following therapeutic areas Cardiovascular, arteriosclerosis, diabetes, nutrition, etc.
