Course Content: This online Good Clinical Practice (GCP) for Investigators training is provided through the European Centre for Clinical Research Training (ECCRT) and is available on the ECCRT virtual campus. All GCP-duties of the investigator and their team according to chapter 4 of ICH-GCP will be elucidated in this course. In addition, the implementation of GCP is explained and illustrated using examples from practice. You will receive hands-on information about mandatory elements such as approval for clinical trials, informed consent, safety reporting and trial specific documentation. Finally, you will learn to link your clinical research tasks with ICH-GCP requirements.

The Learning Objectives include:

• Comprehension of the overall ICH-GCP requirements
• Understanding of the responsibilities of a Medical Doctor within clinical trials
• Knowing what, why and how clinical trial duties are to be performed and documented
• Knowing how to be prepared for audits/inspections

The GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by “TransCelerate BioPharma” as necessary to enable mutual recognition of GCP training among trial sponsors.

Target Audience: Principal Investigators and sub-investigators who need a specific GCP training for Investigators.

Duration: The course takes approximately 3 hours. It can be started and stopped at any time, and can be completed within 3 months after registration.

Certificate: Upon successfully completing the course and final exam, an official GCP certificate can be downloaded.

Registration: Please send an email with the following information to vaccelerate@umcutrecht.nl to register for this course:
-Your First and Last Name
-Email Address
-Institution Name
-Country
-Study Team Role (Principal Investigator, Sub–Investigator, Medical Staff/Physician, Study –Nurse, Study Coordinator, Project Manager, Other)
-Which course(s) you are interested in
-If you are involved in a VACCELERATE study (yes, no – if yes, which study)
-How you found this course (via VACCELERATE social media, VACCELERATE website, institutional information channels, EUVAP emailing, VACCELERATE National Coordinator, VACCELERATE newsletter, Other)

Course Content: This online Good Clinical Practice (GCP) Refresher is provided through the European Centre for Clinical Research Training (ECCRT) and is available on the ECCRT virtual campus. The training is specifically for professionals who already have knowledge of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) standard but need to update and refresh their knowledge. This interactive eLearning course is designed as a refresher and will cover the responsibilities of all players in the clinical research field.

The Learning Objectives include:

• Refreshing Definitions and Principles of GCP
• Responsibilities for all involved persons/parties
• The essential GCP-related documents
• Impact of the 2016 GCP addendum for Investigators and for Sponsors
• GCP Audit Findings at the Sponsor and at the Investigational Sites

Target Audience: Principal Investigators, sub-investigators, physicians, medical staff, study coordinators and project managers who need a GCP refresher training.

Duration: The course takes approximately 4 hours. It can be started and stopped at any time, and can be completed within 3 months after registration.

Certificate: Upon successfully completing the course and final exam, an official GCP certificate can be downloaded.

Registration: Please send an email with the following information to vaccelerate@umcutrecht.nl to register for this course:
-Your First and Last Name
-Email Address
-Institution Name
-Country
-Study Team Role (Principal Investigator, Sub–Investigator, Medical Staff/Physician, Study –Nurse, Study Coordinator, Project Manager, Other)
-Which course(s) you are interested in
-If you are involved in a VACCELERATE study (yes, no – if yes, which study)
-How you found this course (via VACCELERATE social media, VACCELERATE website, institutional information channels, EUVAP emailing, VACCELERATE National Coordinator, VACCELERATE newsletter, Other)

This course is designed for study nurses and will provide the needed expertise to conduct a clinical trial. Study nurses are responsible for organizational processes and they are the central link between physicians, patients, sponsors, clinical research organizations, and ethics committees.

The course is based on the curriculum of the KKS Network, a German association of academic coordinating centers for clinical studies, and uses the standards set out in ICH GCP E6 (R2).

Next to the regulatory background the course also tackles and trains practical aspects necessary for the work as study nurse.

The course consists of 3 modules including, among others, the following topics:

First Module:

• General information and basics of clinical trials
• Regulatory aspects, ethical guidelines, and principles of clinical trials
• Study protocol, patient information and informed consent
• Adverse events

Second Module:

• Practical information for the trial site, study preparation and site organization
• Documentation and handling of study data
• Patient recruitment and visits
• Safety

Third Module:

• Quality control and completion of studies
• Monitoring and audits
• Archiving and essential documents
• Ethical evaluation

Total duration of the course is approximately 30 hours.

Course Content: This online Clinical Development Of A Vaccine course is provided through the European Centre for Clinical Research Training (ECCRT) and is available on the ECCRT virtual campus. This course describes the characteristics of a vaccine trial in general and differences between vaccine trials and drug trials, identifies possible issues and challenges within vaccine trials, and lets you understand the biologics business. In addition, the course highlights the specific regulatory requirements, including the quality, safety, efficacy, and clinical trial performance, in the development of vaccines, and the requirements for a pharmaceutical company to successfully achieve the development, licensing and marketing of vaccines.

The Learning Objectives include:

• Explaining the particularities of a vaccine trial compared to a drug trial and the types of participants, and organization of recruitment, in a vaccine trial
• Describing the biologics business
• Identifying challenges and possible issues
• Illustrating the theory with examples of recently conducted vaccine trials

Target Audience: Principal Investigators, sub-investigators, study coordinators and project managers who need training on the Clinical Development of a Vaccine.

Duration: The course takes approximately 1.5 days. It can be started and stopped at any time, and can be completed within 3 months after registration.

Certificate: Upon successfully completing the course and final exam, a certificate can be downloaded.

Registration: Please send an email with the following information to vaccelerate@umcutrecht.nl to register for this course:
-Your First and Last Name
-Email Address
-Institution Name
-Country
-Study Team Role (Principal Investigator, Sub–Investigator, Medical Staff/Physician, Study –Nurse, Study Coordinator, Project Manager, Other)
-Which course(s) you are interested in
-If you are involved in a VACCELERATE study (yes, no – if yes, which study)
-How you found this course (via VACCELERATE social media, VACCELERATE website, institutional information channels, EUVAP emailing, VACCELERATE National Coordinator, VACCELERATE newsletter, Other)

Course Content: This training course is designed to familiarize personnel from clinical trial units and sites (project managers, study coordinators, etc. ) from the public and the private sector with the challenges of initiating and managing multinational trials. The main objective of this course will be solution-oriented to address the most common barriers in the European landscape. Among the obstacles are the variety of national implementations of the European Regulation on clinical and vaccine trials that govern the European clinical research as well as ethical considerations. The early identification of roles and responsibilities of all stakeholders, in both industry and academic research, as a key aspect to ensure good management of the clinical trial and effective harmonization among participating countries, will be covered. In addition, funding sources and key elements of budget preparation when conducting multinational clinical trials will be covered, as well as the role of clinical trial data sharing and GDPR when sharing sensitive data across borders. Primary considerations on how to plan clinical research that include data sharing plans, tools and services will be highlighted.

Target Audience: Principal Investigators, sub-investigators, study coordinators and project managers who need training on the management of multinational trials.

Duration: The course takes approximately 2 hours. It can be started and stopped at any time, and can be completed within 1 month after registration.

Certificate: Upon successfully completing the course, a certificate can be provided.

Further details following soon.