Rules for establishing registers

Steps in establishing a register and the experts required:

  1. A basic condition of creating a register is to ensure quality and the optimum acceptance possible within the field. It is recommended that every register should be established following a national or international discussion. It is desirable that a register should also be supported by a society or study group.

  2. Approved register questionnaires are then forwarded to the UP CTM MRG, where an electronic data upload option will be created. The UP CTM will set up electronic clinical research forms (CRF) with the participation of the biostatisticians and data managers and in regular consultation with the initiators of the register.

  3. The UP CTM will obtain the required Hungarian ethical permissions. In consideration of the fact that ethics rules differ from one country to the next, any foreign institution wishing to join must obtain its own local approval itself.

  4. The UP CTM will assist its partners with the international distribution of the register. It will thus be in a unique position to increase the number of patients entered into the registers.

  5. Quality control of the registers is regularly maintained by the UP CTM in conjunction with the initiator of the register.

  6. The UP CTM shall guarantee secrecy. It shall enter into a contract with its partners in that regard. Secrecy involves the following:

  • Data belongs to the party that has uploaded it, and thus other researchers may not access it.

  • Uploaders may only access their own data. However, everyone will be able to see the total number of patients with data in the system.

  • If an individual has an idea for research, it must be submitted to the UP CTM. The centres themselves will decide if they wish to participate in that particular research.

  1. Research and publishing. Complete transparency is characteristic of this phase. Participants must observe the following:

    1. The UP CTM will not interfere in the matter of first and last authors. This is to be decided by those conducting the research.

    2. With regard to the question of co-authors, the UP CTM may indicate authors (from among staff who have worked successfully in terms of the number of patients or the register) while maintaining complete transparency.

    3. Sponsors named by the UP CTM must be indicated in the acknowledgements.

  2. The UP CTM will provide regular consultation with the biostatisticians for every member.

  3. The initiators of the register, that is the PIs, will be bound by the following obligations:

  • The party establishing the register must provide regular professional monitoring and participate in approving the forms. After an appropriate number of units, they must prepare a report. They must participate in regular, bimonthly meetings with the MRG and report on their findings and concerns. (This may take place by Skype in the case of international partners.)

  • The UP CTM must represent the interests of the uploaders, not only those of the initiator. The UP CTM is entitled to remove a PI who fails to perform their duty and decide on a new PI to replace them in agreement with the centres uploading the data.