
By R. Jennifer Cavalieri
Clinical study guide: functional instruments and Templates for handling medical learn is the must-have ebook for someone operating within the daily operations of a study research or medical trial. choked with instruments, thoughts, and templates, this handbook deals medical researchers, critical investigators, and study coordinators the basis they should effectively set up advanced trials.
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Extra info for Clinical research manual : practical tools and templates for managing clinical research
Sample text
Research coordinators are responsible for supporting the day-to-day clinical trial activities, which includes tracking the sponsor and site stakeholders, research efforts, and study subject visits. Research coordinators who are involved with clinical trials involving human subjects are often nurses, medical technologists, or respiratory therapists. Some Essential Functions to Consider Administrative duties in research may include working with study sponsors, supervising research personnel, supporting regulatory compliance, maintaining financial records, establishing standard operating procedures (SOP), and acquiring physical materials, such as property, equipment, supplies, and space.
For example, the sponsor may provide an electrocardiogram machine for the site to use for research subject assessments during the trial but expect that it will be returned to the sponsor at the end of the study. All equipment requires periodic inspection and calibration. Check whether your institution has personnel who can perform these routine services and repairs. For research purposes, documentation of the equipment tags and calibration records is usually subject to inspection. A photograph of the equipment can be placed in the file and may prove to be useful.
So if you were to ask research professionals in a variety of different research and institutional positions what they would wish for to make their research activities easier, their answers might be: Investigators: • Adequate budgets • Smooth site operations • Well-designed protocols Finance administrators: • Clear, upfront instructions on the study payment process and detailed statements accompanying the sponsor payments • Details about financial contacts and payment triggers • A realistic estimate of the number of subjects that will be enrolled so that department budgets can be planned Site contract personnel: • Prompt completion of the necessary information and documents so that they can proceed with contract negotiation • Understanding from sponsors and investigators that some things are beyond the control of the contract negotiator • Not being used as a scapegoat when delays occur in getting a contract finalized Research coordinators: • Ability to network with other research coordinators internally and externally to gather tips and ideas about study logistics • Additional background information about the medical condition being studied, including information on signs and symptoms, diagnostics, and prognosis CHAPTER 2: Site Administration • User-friendly electronic case report form (eCRF) IT systems • Movement of sponsors and monitors away from using FAX processes for sending in screening logs and ordering supplies to employing a web-based system that can also serve as a “real-time” newsletter and enrollment tally Investigational pharmacists: • Communication, communication, communication • Friendly research coordinators, collegial respect and teamwork, and positive attitudes • Reduction of redundant forms from sponsors Clinical laboratory personnel: • Clear instructions from investigators regarding what they want them to do or the types of tests required • Friendly research personnel • Research personnel who are conscientious and tidy when working in their lab space Clinical caregivers: • Communication about what research personnel are doing to their patients • Instructions regarding what the PI wants them to do • The study results Biostatisticians: • Inclusion in planning meetings • Involvement in discussions about data collection • Involvement in the development and formatting of the data spreadsheets in preparation for the analysis This shows each team member’s perspective, and, by communicating with colleagues, you may find opportunities to implement improvements to the work environment.