Čeština | Dansk | Deutsch | English | Español | Français | Italiano | Nederlands | Norsk | Polski | Português | Pусский | Suomi | Svenska | US
Euro Huntington's disease network [logo]
Projektit - Ehdotukset - Kliiniset kokeet -
Any member of EHDN may apply to the Scientific and Bioethics Advisory Committee (SBAC) for endorsement of an EHDN clinical study by submitting the following information (submission page):
  • Project title and summary (word limit 250 words)
  • The names and contact details of the principal investigator (PI) and co-principal investigator (Co-PI). The PI and Co-PI, who may be members of the Steering Committee, should represent different institutions
  • The names of the members of the steering committee for the clinical study. In addition to the PI and Co-PI, and unless the small size of the clinical study warrants otherwise, a steering committee should consist of at least three or four independent investigators, the biostatistician for the study, and a coordinator of the study
  • The proposed sponsor
  • Study protocol (word limit 1500 words, can be uploaded as word document)
  • ERB approval (upload word document or scanned and uploaded as image file e.g. GIF or JPG)
  • Type of study, study period, study population and number of subjects
  • Main inclusion and exclusion criteria
  • Sample size considerations
  • Requested start date
Ethical considerations

Applicants of studies on humans, especially those involving placebo, symptom provocation, drug discontinuation, or patients with impaired decision-making capability, should consider the ethical issues involved. Applicants should provide detailed information on the informed consent process, including the method(s) used to assess the subject's capacity to give informed consent, and safeguards included in the study design for protection of human subjects. Specifically, applicants should consider all ethical issues relevant to their application, and briefly address each of these in their application.

Study registration

Application for clinical studies requires the registration of all clinical studies whose primary purpose is to affect clinical practice (http://eudract.emea.europa.eu/). The International Committee of Medical Journal Editors (ICMJE) defines a clinical study as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
The Principal Investigator and Co-Principal Investigator of an EHDN clinical study are responsible for:
  • The design of the study
  • Assembling the steering committee for the study
  • Study registration
  • Securing adequate sponsorship and support for the study and ensuring an appropriate funding mechanism
  • subcontracting, through his or her institution, with the participating investigators and their institutions
  • subcontracting, through his or her institution, for study coordination services
  • If appropriate, forming study subcommittees to assist in the planning and implementation of the trial. These subcommittees may include: an independent (safety) monitoring subcommittee, a budget subcommittee, and working groups to oversee secondary analyses and their publication
  • Overseeing the implementation, and supervising the analysis and reporting for the study
  • Together with the steering committee, supervising the accuracy of the data collected in the study
The steering committee of an EHDN clinical study is responsible for
  • Selecting site investigators for the study, and for assisting the Principal Investigator and Co- Principal Investigator in the implementation, analysis and reporting of the study results. Participating site investigators for a study should be selected from the current EHDN listing of qualified investigators who request participation in EHDN trials
  • Removing from active study participation any steering committee members, investigators or other study personal, that do not fulfil his/her obligations to the trial or that do not maintain the standards of EHDN with respect to confidentiality, professional conduct, rights of research subjects, conflict-of-interest, disclosure or publication policies.
All endorsed EHDN clinical studies and steering committees can make use of services provided by the EHDN Central Coordination and Language Area Coordination of EHDN. All EHDN steering committees will also ensure that study policies governing confidentiality, human subjects, clinical practice, conflict-of-interest and publication are consistent with policies contained in the EHDN constitution.
Download: Endorement criteria for proposed clinical trials
application/pdfsbac-endorsement-criteria-clinical-tri...