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  • 1. Poor communication between centers, sponsors and with Contract Research Organizations (CROs)

    > Clear communication plan with defined contact persons

    Regular meetings / conference calls to ease communication

    > Define (together with the sponsor) on who should be at which study-related meetings – e.g. study kickoff meetings, monitoring visits etc.

    Find out about the most convenient way of communicating (e.g. via telephone, e-mail etc)

    Thorough training on study documents, possibility to ask for clarifications

    If applicable, to create a document where frequently asked questions (FAQ) are collected and made available for the whole study team.

     
  • 2. Poor communication within the study team

     

    > Clearly defined responsibilities and ways of information transfer

    Regular internal study meetings

    Find the most convenient way of communicating (e.g., telephone, e-mail)

  • 3. Poor relationships between research organizations and other stakeholder groups

    > Regular internal meetings, good communication

    Well-defined processes

    Agreements where the responsibilities, tasks and timelines are defined

  • 4. Non-supportive research environment in the clinic, difficulties with legal and administration departments, hospital politics etc.

    > Clarify prior to study initiation which departments are or should be involved in clinical research activities

    Have a clinical trial unit with clear processes and responsibilities in place, if feasible

    Internal advertisement of previous achievements in research

    Alignment of research focus with the overall goal and mission of the clinic management

    Employment of a study coordinator who is the key person to coordinate all research activities

    AO Clinical Study Center (AOCSC) qualification program (add link)

     
  • 5. Poor team spirit within the research team

    > Provide enough resources to perform research

    Clearly define responsibilities and processes (see AOCSC program)

    Provide incentives for research teams (e.g., participation in networking events, courses, congresses)

     
  • 6. Poor research skills in the participating clinics

    > Organize trainings on good clinical practice, how to setup a clinical study, how to develop a clinical database, how to write a scientific publication, etc.

    Provide enough time resources for such training

    Develop an environment to learn and give feedback

    Setup a research mentorship program where members of the research teams can get help

     
  • 7. Turnover of employees involved in the clinical study team

    > Develop clear criteria on how to be part of a research project and inform about the responsibilities and incentives

    Create a supportive research atmosphere including enough time resources

    Guarantee good documentation and a proper hand over by having clear responsibilities and a deputy system in place, as well as informing early about any changes and the successor in a project

     
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