In the highly regulated world of clinical trials, successful core lab teams are comprised of proactive problem-solvers. Project Managers solve problems with timelines and teleconferences; Data Managers solve problems with spreadsheets and scripts; Quality Assurance Specialists solve problems with checklists and standard operating procedures. Medical Writers solve problems by formulating accurate clinical trial documents.
Each imaging clinical trial starts with the Imaging Review Charter, a comprehensive description of every service that the central imaging vendor will provide. This document, colloquially known as the “Charter”, describes site qualification, image analysis, data delivery and everything in between. Although the industry has effectively standardized the format, every Charter must be customized to harmonize with a given clinical trial protocol.
When a Charter is requested, a Medical Writer begins by reviewing source documents such as the latest versions of the clinical protocol, proposal, and contract. Sometimes the Medical Writer discovers contradictions between source documents: the clinical study protocol may have been amended after the budget was finalized so that the sponsor expects a central confirmation of eligibility when the contract does not include it. Inconsistencies in source documents demand the Writer’s persistence and dedication to ensure each detail is correct before sending the Charter for internal review, revising as necessary, and delivering to the sponsor.
Typically, feedback is compiled via change-tracking software. It requires patience to make sense of the rainbow of colors representing every single reviewer edit and comment. Sometimes a change requested in one section requires changes in several other sections to ensure consistency within the document. In other cases, edits require confirmation from a busy Radiologist or Imaging Scientist to ensure that the customization can be implemented without unexpected consequences. Only when all revisions are confirmed and every comment is addressed, can the Charter be returned to the sponsor for approval.
Imaging Review Charters are designed for submission to regulatory agencies and govern the activities of the imaging contract research organization. With each Charter, the Medical Writer strives for perfection to avoid timeline delays and to ensure that downstream processes such as study setup and software development proceed smoothly. By accurately describing central review of imaging, the Medical Writer enables the patients who have volunteered for the clinical trial to make their intended and essential contribution to science and human health.
Persistence, patience, and perfection are just a few of the tools a Medical Writer uses to solve problems with words, to achieve an imaging review charter that is right first-time on-time, and to provide the Sponsor with the high-quality service they expect.
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