In a previous Innovations in Biopharma newsletter article, Syner-G discussed some of the most common errors found during the quality control (QC) process in medical writing and how to avoid them. Here, we will explore various resources and tools available to a QC reviewer to assist them in identifying these errors. At Syner-G, we write and QC a wide range of document types including clinical study reports (CSRs), protocols, investigator brochures, investigational new drug applications, among many other clinical regulatory documents. These documents are the product of a wealth of prior research and writing that may take the form of clinical trial data packages, statistical analysis plans, study reports, and literature written by experts in the field. Applying and synthesizing that information into a new document appropriate for the specific stage in a drug’s development can be tricky and fraught with potential for error. Thus, it is the QC reviewer who is tasked with verifying the newly created document against its source.
Sources for QC
Pre-programmed Tables, Figures, and Listings
What is considered a source document, then? And how is it a tool in the QC process? Source materials, such as data tables, figures, and listings compiled following a clinical trial, are the evidence for the messaging in regulatory writing. The QC reviewer will cross-reference data and text between the deliverable and source material to ensure that the information is presented accurately. For example, if an adverse event occurred during a clinical trial, information such as the severity and outcome stated in a CSR will be verified against a listing which will include the details of the event entered into the study database.
Consolidated Team Review Comments
Regulatory documents are produced as part of an iterative process. In other words, multiple drafts are written and revised to refine the document into the best possible version within the constraints of time and its intended purpose. As a result, a QC reviewer will account for edits and commentary by the various stakeholders involved to ensure updates have been implemented correctly and consistently. As a “source”, these will take the form of team comments or roundtable documents which will include all the feedback and input from scientific review.
Style Guides
A touchstone for QC reviewers, in addition to source documents, is the style guide. A style guide serves as a reference for the medical writer to ensure compliance with a sponsor’s own set of writing conventions. A QC reviewer is required to have a thorough knowledge and understanding of the applicable style guide to confirm that the document will be submission ready and that multiple documents within the same program are consistent. Examples of study- or sponsor-specific style guides may include rules on how literature references should be cited, rules for use of abbreviations in the document, or consistent naming conventions for the drug product and/or study participants.
Software
Collaboration between the QC reviewer and the author of the document is vital. Syner-G QC Specialists rely on information from the author in order to understand the scope of a QC task. As previously mentioned, a document undergoes multiple drafts and will not require the same level of QC at each iteration. For example, while a first draft QC will usually undergo a full verification of the entire document, a subsequent or final draft will only require the QC of what has changed since the previous draft. This clear identification of scope ensures efficiency and avoids duplication of effort. A QC checklist can provide guidance as to what type of QC is needed at any given point in the development of the document. Whether that may be to check whether abbreviations have been used accurately and consistently, or that the in-text references have been correctly cited in the document, a checklist confirms to both the QC reviewer and the medical writer that everything within the document has been verified during that document’s lifecycle.
Effective use of software tools such as project management (PM) programs and word processing tools is vital for QC groups to navigate timelines and documents. The Medical Writing Services group at Syner-G utilizes a software platform shared by QC reviewers and medical writers to manage QC assignments and ensures adequate resources are devoted to each document. This tool enables the team to plan during peaks of high volume and respond quickly to timeline shifts which are a common occurrence in the industry. Project management tools are essential to keep the QC team agile and carefully resource tasks throughout the year.
Lastly, understanding the capabilities of word processing tools such as MS Word is equally important in comprehensive and timely QC completion. Regulatory documents are often inherently complex and sophisticated in their content and structure (and sometimes very long!); therefore, leveraging the range of features in word processing software is necessary to access information quickly, provide valuable feedback, and present findings clearly. When editing is needed as part of a QC, knowing how to implement changes that conform to the formatting and structure of the document means less work for the medical writer and a reduced risk of unwanted changes.
Syner-G’s QC Tools: Expertise and Experience
While the skills and experience of the QC reviewer are the primary tools to help ensure quality deliverables, they employ various resources at their disposal to assist them in that effort. At Syner-G, the combination of skills, with careful attention to process and application of available resources, enable us to maintain such high standards from our QC team.
