The ICSSC conducts training sessions in a variety of venues, both on and offline. These include on-location at international sites, at selected international regional locations, and on-location at FHI 360 headquarters in Durham, NC. The ICSSC has made web-based trainings available in the form of live Webinars as well as self-guided e-learning modules for selected topics. Some trainings can be made available in other languages.
The Fundamentals of Clinical Research Workshop: This workshop provides an overview the essential aspects of conducting a clinical study, as required by DMID. This workshop covers protocol development, study design, biostatistics, data management, good clinical practice, ethics, field operations, safety oversight, etc. Sample Agenda
Data Management Training: The ICSSC conducts training on data management at various levels. These trainings cover GCP compliance, data management planning, CRFs, quality assurance, and programming, among others. Sample Agenda
Science Writing Training: This workshop covers all aspects of the development and publication of a scientific manuscript. It includes an overview of each section of a manuscript, writing tips, and strategies for getting published. This training may include intensive editing sessions of a participant’s manuscripts. Sample Agenda
Biostatistics Training: The ICSSC conducts training on numerous biostatistics topics at basic and advanced levels, as needed, with an emphasis on analytic methodologies. Sample Agenda
Study Design Training: The ICSSC conducts trainings focused on study design. The observational epidemiological workshop addresses the primary analytical epidemiological study designs, cohort studies, and case-control studies. The randomized controlled trial workshop addresses the fundamentals of randomization, retention, and blinding. The advanced trial workshop tackles more complicated randomization approaches as well as special analytic challenges. Sample Agenda
Good Clinical Practice Training: This workshop covers the required international standards on the conduct of human subject research. It includes DMID policies, guidelines, and other regulations. This training is available in Chinese, Spanish, Portuguese, French, and Arabic, and makes use of simultaneous translation. Sample Agenda
Laboratory Quality Improvement and Safety Training: Topics covered include good laboratory practice, quality and safety regulations, quality management requirements, and care and use of equipment. Sample Agenda
Research Ethics and IRB Operations Training: The ICSSC conducts two trainings on research ethics. One covers essential topics in the Protection of Human Research Participants and another addresses both research ethics and Institutional Research Board (IRB) Operations. Sample Agenda
Attendance at these events is by invitation only. DMID-funded researchers can submit a request for an ICSSC event by using the Request Assistance form.
Thirteen learning tutorials covering an array of data management topics—which are typically offered only in face-to face training—are now available through a self-guided, online format. This online learning resource, like the face-to face training, focuses on the design and conduct of data management processes in accordance with GCP and 21 CFR Part 11 guidelines. The modules can be studied individually, as each module is self-contained—or as comprehensive training. In general, the modules take 30-60 minutes to complete with a quiz at the end of each unit.
Please note that this online training is available only for investigators funded by the DHHS/NIH/NIAID Division of Microbiology and Infectious Diseases (DMID).
Please contact Laura Phillips at email@example.com if you have any questions or if you are interested in participating in the program.
Good Clinical Practice: Offered through NIAID http://gcplearningcenter.niaid.nih.gov/Pages/default.aspx
Offered through FHI 360
Offered through the NIH office of Extramural Research http://phrp.nihtraining.com/users/login.php