BHS Clinicial trials
List of BHS trials
- The BHS may initiate academic clinical research trials in the field of Hematology.
- The sponsor of these trials must be a Belgian University or a Belgian Hospital that has a department of Hematology with a registered Specialist in Internal Medicine with a special competence in Hematology.
- These trials must abide by all applicable rules and laws of Belgium and be conducted according to international Good Clinical Practice (GCP) guidelines. Among other requirements, this implies that all such trials are approved by Ethics Committees and the National Competent Authority (for Belgium : the AFMPS/FAGG), and benefit from a trial insurance.
- To facilitate such clinical trials, the BHS may proceed to the recruitment of one or more Clinical Research Assistants (CRA).
Role of the BHS CRA
- CRA working for the BHS will not be directly employed by the BHS, but shall be employed by a Belgian Hospital that has a department of Hematology with a registered Specialist in Internal Medicine with a special competence in Hematology.
- A first BHS CRA has been hired half-time in July 2012 : click here to obtain contact information.
- The BHS-CRA will help to set up, monitor and complete BHS clinical trials in accordance with the GCP guidelines. Typical work activities include :
- writing of protocol and related documents
- submission to competent authorities and Ethics committees,
- protocol presentation, briefing investigators, conducting initiation visits
- data collection from local data managers, conducting monitoring visits
- pharmacovigilance, AE management
- document management, preparing reports…
- A local (working in the same hospital) BHS investigator selected by the BHS board shall directly supervise the BHS-CRA.
- The BHS-CRA shall work under the direct authority of the CRA supervisor, but after the BHS board has defined his/her general role and the protocol portfolio under his/her responsibility.
- If the CRA supervisor wishes to change significantly the responsibilities of the BHS-CRA with regards to a specific BHS protocol, this will have to be approved by the BHS board.
Assignment of BHS protocols to the BHS CRA
- Belgian academic protocols are discussed within the BHS committees.
- The BHS committees have the responsibility to approve and label protocols as « BHS protocols », and to designate a principal investigator (PI) who will be in charge of the study.
- The PI must be a member of the BHS, but can be from any hematology clinical center (does not need to be from the hospital to which the BHS-CRA is attached).
- The PI of a study shall be responsible for resolving any issue concerning regulatory or clinical aspects of the BHS protocol, and for providing the BHS-CRA with answers to any questions relevant to his/her tasks.
- The BHS committees can submit to the BHS board a request to have administrative support from the BHS-CRA. This request shall be done by sending to the board and to the CRA supervisor :
- A request form, which details information such as : name of the committee, committee chair, study title, PI name, financing sources of the protocol and if there is money planned to pay for the data monitoring, and a list of requested tasks for the BHS-CRA.
- A synopsis of the study, using the « BHS protocol summary template ».
- Support can only be requested for academic trials as defined under “General setting”. Support cannot be requested for commercial protocols or for protocols sponsored and/or organized by international organizations such as the EORTC, LYSA, HOVON, IFM…
- BHS committees and investigators are strongly encouraged to find financing sources to support the data monitoring of their studies. This effort will be part of the decision to approve the CRA support. If such co-financing is not feasible, this should be clearly justified.
- The BHS board shall define the responsibilities of the BHS-CRA with regards to a selected BHS protocol. This means that the BHS board can decide that the BHS-CRA tasks could be limited to specific aspects or several of these aspects. The decision of the BHS board shall take into account :
- the request of the BHS committee.
- the funding sources available to contribute to the payment of the BHS-CRA salary and costs.
- the workload of the BHS-CRA (number and complexity of BHS protocols managed by him/her), and the opinion of the CRA supervisor.
- The BHS CRA SOP describes the detailed procedure for recruiting and organizing the work of BHS CRA.