Introduction to Effective Medical Writing

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This is a Core Course for the following Certification Track(s):

  • Certified Medical Writing Professional (CMWP)™

  • COURSE DETAILS

    Course Description

    Clear, readable medical writing verifies product integrity. It provides a history of product development as companies publish study results in professional journals and submit documentation to regulatory agencies. If the writing is good, it is also cost effective. In the clinical setting it can help prevent the need for additional costly clinical trials, which agencies can require if documents don’t accurately reflect sound science or technology. Poor writing frequently slows the review process as well as regulators ask for clarification and additional documentation, while well-written submissions optimize the review process and increase the amount of time a product remains under patent protection. This course provides an overview of how to present product information clearly and concisely for targeted audiences. Hands-on exercises reinforce the course content.

    This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

    Who Should Attend

    This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions. It will also benefit professionals who prepare or review articles and abstracts about therapeutic products in any phase of development for professional publication. The course is particularly helpful for those new to the discipline who wish to understand the scope of medical writing. Typical attendees include medical writers, reviewers of medical documents, clinical research managers and associates, regulatory affairs professionals, project physicians and medical monitors.

    Learning Objectives

    Upon completion of this course you will understand:

    • What medical writing encompasses
    • How to write documents that meet the company’s goals and objectives
    • Why publishing is an essential part of therapeutic product position
    • How to write an abstract or manuscript
    • How to control sentence structures for precise delivery of data
    • How to increase clarity and effectiveness through tone and voice
    • How to create effective data displays
    • The role of the writer in producing and issuing documents
    • How to overcome Writer’s Block
    • How to produce documents within controlled timelines
    • The best ways to manage the review process
    • What kind of feedback is useful to other writers
    • How to reach concurrence in the review process

    Past Participants' Comments

    "CfPIE organizes a great course! The Course Director provides excellent material. She gave great examples, and supported them during workshop activities. She also invites questions for future follow-up. It has been a pleasure to return to CfPIE for a new course topic and have a familiar instructor that was enjoyable the first time. I'm looking forward to my next course and eventually completing my certification." Karin B., Technical Writer III, Gen-Probe
    "An excellent orientation for new writers as well as detailed, comprehensive strategies for successful submissions that will be useful for experienced medical writers." Diahann H., Consulting Medical Writer, Abbott
    "Very useful course! The review of basic language and grammar concepts such as active/passive voice, parallel form, use of punctuation, etc. was very helpful as these concepts have not been reviewed since middle school. Appropriate pace throughout the course and also great discussion among attendees. The Course Director is a great teacher and really engaged students. Thank you!." Anupma R. – Post Doctoral Fellow – Cubist Pharmaceuticals
    "The course went above and beyond my expectations. It was extremely informative and the instructor was knowledgeable and dynamic." Marie V., Project Coordinator, SuperGen
    "As a Document Specialist for Novartis, who reviews protocols and study reports to ensure that they meet all FDA and internal guidelines, I found this course to be extremely helpful and informative. The course afforded me a better understanding of the details of writing a Study Report. I will inform my management of how important this course will be to help all new hires, as well as, seasoned scientists who need to become more effective writers." Theresa M., Document Specialist, Novartis
    "Best presentation on Medical Writing ever!" Diane B., Coley Pharmaceuticals
    "I enjoyed the Course Director's presentation and communication. I gained a wealth of knowledge . I know have a better understanding of the writing process." Joanne A., Sr. Med Affairs Coord, Bayer Healthcare Pharmaceuticals
    "Content – Perfect balance; Director – They don't get any better; Group make-up – Very good for input, contribution, and contacts." Colette L., MD, FRCPC, CRC Partners STD
    "This was an excellent course for me in my current work in protocol review and leading medical imaging charter development. The group sessions were helpful to gain an alternative thinking and writing approach. I will definitely attend future CfPIE courses and encourage my leadership to send my colleagues." De Jane H., Director, Medical Imaging, Amgen
    "The Course Director provided very useful information and outside references, and offered continued assistance and resources after the conclusion of class. Great instructor, great class." Darlene N., Sr. Process Engineer, Covidien
    "The Course Director was wonderful! Her teaching style was extremely friendly and informative. It was refreshing to see genetics examples of medical writing in our class, which is my specialization. I will return to take the other medical writing courses for the certification program. Thanks again to the Course Director and your staff who were pleasant and provided excellent service." Valerie K., Clinical Documentation Specialist II, Alexion Pharmaceuticals

    Frequently Asked Questions

    What documentation does a company need to start a clinical trial in the United States?

    A clinical trial can only occur if extensive preclinical testing is adequate to show that a product is safe for testing in humans. The company must have controlled records of all product development activities leading up to testing in humans. A submission to the agency then draws upon the nonclinical documentation and summarizes it as proof of a viable test candidate. An Investigational New Drug application (IND) for drugs and biologics or an Investigation Device Exemption (IDE) for class III devices typically includes applicable forms, such as Form 3674 (Certification of Compliance); an introductory statement and a general investigational plan overview; the actual protocol; an Investigator Brochure (IB), which provides information for the investigators; chemistry, manufacturing, and controls and/or design controls; and pivotal nonclinical studies. The company must have adequate SOPs in place to cover clinical activities, such as PI and site selection, data collection, trial monitoring, and trial document management. Electronic record keeping systems for trials also require validation and the resulting documentation.

    Is there a requirement for publishing in scholarly journals as we complete clinical trials?

    Transparency is the reality today, and the expectation is that companies will publish results of clinical trials. The International Conference on Harmonisation (ICH) E6 Good Clinical Practice specifically calls for a publication plan as part of clinical development. Further, FDA mandates trial registration (public law 110-85, Section 810), and most journals also require registry of a phase 2, 3, or 4 clinical study on a publicly accessible database, such as clinicaltrials.gov or Eudra.Pharm.eu. These registrations link to related publications.

    How can we determine authorship of the articles we publish?

    The International Committee of Medical Journal Editors (ICMJE) defines authorship. “An author must take responsibility for at least one component of the work, should be able to identify who is responsible for each other component, and should ideally be confident in their co-authors’ ability and integrity…Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research” (ICMJE.org). Thus, conducting research and determining results are a basis for authorship. Other people, such as medical writers, may assist in compiling and organizing information and preparing and editing manuscripts. Such contributors deserve acknowledgement.

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