Training and Coaching Research Professionals
Clinical research has always played a prominent role in both teaching hospitals and major peripheral clinics. The Dutch Government creates a framework within which all drug studies must be performed, consisting of national and international laws and guidelines. Worldwide medical researchers adhere to the Good Clinical Practice guidelines while Europe has contributed the Clinical Trial Directives for scientific research. On a national level the Netherlands passed two relevant laws, i.e. the Law on Medical Research with Humans Subjects (Medisch Wetenschappelijk Onderzoek met Mensen, WMO) and the Personal Data Protection (WBP).
To perform research in compliance with existing rules and regulations you need qualified staff with the specific skills and competencies. Penthecilia will make your staff aware of tasks they often perform intuitively. We will teach them specific knowledge and insights, helping them to enhance their job performance and maybe that of non-participating colleagues as well.
The purpose of ICH-GCP training is to offer participants new knowledge and insights and to teach them specific skills for setting up and carrying out clinical research projects, ultimately helping them to do a better job. Any scientific research consists mainly of the accurate documentation of research data in essential research documents. Accuracy is crucial, since inaccurate or incomplete data will compromise the validity of the results and therefore their quality. During the training sessions we will extensively treat various processing methods of research data, their consequences and the research administration tasks. Before any clinical research project can take place, a research proposal has to be submitted to an IRB/IEC. Training subjects include the applicable rules and regulations for this review process, the committee’s tasks and responsibilities, ethics and the subject’s rights and obligations.
It is possible for Penthecilia to tailor training programs to the specific needs of the participants and their level of knowledge and experience. We also provide on-the-job coaching, giving research employees personal and direct training on their own research site.
Training and workshop possibilities:
- GCP training for investigators and site personnel, beginners and advanced (general and tailor made).
After the two day GCP course participants can follow-up for an e-learning exam organized by the ST. CKWO and performed by Mediavision.
For more information about this e-learning exam, please contact Cecilia Huisman, email@example.com.
- Informed Consent procedure
- How to write a SOP?
- How to write a patient information letter ?
- How to perform a feasibility analyses for your study?
For more information about the training, workshops and costs, please contact Cecilia Huisman, firstname.lastname@example.org
For the GCP training the application for receiving accreditation is in process.