{"product_id":"key-considerations-in-medical-writing-the-clinical-study-protocol-investigator-s-brochure-informed-consent-form-and-adverse-events-narratives-2026-09-10","title":"Key Considerations in Medical Writing: the Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar includes a high-level review of the key considerations and the current trends for the clinical study protocol, the Investigator's Brochure (IB), the informed consent form, and adverse event narratives. While these documents form the basis and often predict the success of any drug or device development program, there is much variation between companies and individuals on how to approach writing these critical documents. In this web seminar, key considerations that should be taken into account in the development and maintenance of these documents will be discussed.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe current trends and key considerations for clinical study protocol writing\u003c\/li\u003e \u003cli\u003eReview required and optional elements of informed consent, criteria for language and comprehension by research subjects\u003c\/li\u003e \u003cli\u003eReview serious adverse event reporting requirements and narrative writing\u003c\/li\u003e \u003cli\u003eDiscuss how to translate safety updates into informed consent and\u003c\/li\u003e \u003cli\u003eInvestigator's Brochure amendments\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eMedical Directors and Physician Investigators\u003c\/li\u003e \u003cli\u003eMedical Writers\/Regulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Associates and Project Team Leaders\u003c\/li\u003e \u003cli\u003eResearch and Development Personnel\/Grant Administrators\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eMarina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-023-L99-P. Released: 3\/24. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375373115757,"sku":"BI17418","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/key-considerations-in-medical-writing-the-clinical-study-protocol-investigator-s-brochure-informed-consent-form-and-adverse-events-narratives-2026-09-10","provider":"Barnett International ","version":"1.0","type":"link"}