Frequently Asked Questions
How can I participate in a clinical trial as a researcher if I have no experience in the field? expand_more
Our experienced team will provide you with all the support essential to the smooth running of the study and answer all your questions. It is not necessary to have previous clinical research experience to be able to participate in a study in collaboration with Syneos Health ™. A pre-selection process for each clinical study will be conducted to assess your interests and needs for the proper conduct of the study.
What level of involvement is required as a researcher? expand_more
The model we offer is very flexible and aims to adapt as much as possible to your schedule without affecting your other activities. Your level of involvement may vary depending on the therapeutic field involved, the molecule studied, the study protocol and the number of patients participating in the study.
What are my responsibilities as a researcher? expand_more
All researchers are expected to follow the study protocol, regulatory guidelines, and good clinical practice. For more information on the responsibilities of a researcher participating in clinical trials, you can consult the following sources:
- Guidelines of International Council for Harmonisation (ICH)
- Clinical trials.gov
- Health Canada Good Clinical Practices
What is the role of the ethics committee in a clinical study? expand_more
In order to ensure that the safety of subjects is maintained during a clinical research study, the ethics committee must review the study documents. The protocol, investigator’s brochure, informed consent form, and investigator’s qualifications and experience are reviewed before starting the study. At Syneos Health, our study protocols are reviewed by a central and independent ethics committee. If your place of practice has its own local ethics committee (being linked to your institution), you should normally submit the relevant documents to that committee. It is mandatory to obtain the approval of the ethics committee before beginning any study procedure.
Where are the clinical studies carried out? expand_more
Clinical studies can be carried out in your place of practice or in our clinical units in Quebec. Syneos Health offers you various models of collaboration adapted to the current research protocol.
Will my personal information and that of my patients remain confidential? expand_more
We pay particular attention to your personal information to ensure its confidentiality. Your personal information, as well as that of your employees and your patients, will be kept confidential, except when disclosure is required by laws and regulations. Outside of Syneos Health, volunteer participants are identified at all times by a code that does not reveal their identity. The collected study data will be kept in a limited access database for a period determined by local regulations. This data may be viewed in confidence by representatives of the study sponsor, various regulatory agencies such as Health Canada and the United States Food and Drugs Agency (FDA), as well as our ethics committee.
Can my participation allow me to collaborate on the publication of a scientific article? expand_more
Syneos Health encourages the participation of researchers in the publication of scientific articles. Indeed, in some cases, the clinical data of the study could be the subject of publication. It is also sometimes possible that the investigator contributes to these publications with the approval of the sponsor.
Are participating subjects compensated for their participation in a clinical study? expand_more
Study volunteers may receive compensation for their participation in the study.
The amount of compensation is determined based on study procedures such as time spent in clinical premises, frequency of visits, etc.
What is the remuneration offered to the researcher? expand_more
The compensation that will be offered will vary depending on your level of involvement in the study procedures, the time invested and the number of patients recruited into the study.