{"product_id":"writing-clinical-study-protocols-2026-12-15","title":"Writing Clinical Study Protocols","description":"\u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e \u003cp\u003eThe basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval. Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eVideo Preview\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the overall structure of a protocol and regulatory requirements\u003c\/li\u003e \u003cli\u003eDescribe the requirements for a protocol, including:\u003c\/li\u003e \u003cli\u003eEstablishing the indication(s)\u003c\/li\u003e \u003cli\u003eUnderstand the types of studies\u003c\/li\u003e \u003cli\u003eDevelop the protocol design (single blind, double blind, randomized, etc.)\u003c\/li\u003e \u003cli\u003eIdentify the hypothesis\u003c\/li\u003e \u003cli\u003eExplain what safety and efficacy is and how to establish either or both\u003c\/li\u003e \u003cli\u003eDetermine inclusion\/exclusion criteria\u003c\/li\u003e \u003cli\u003eDetermine the Schedule of Events\u003c\/li\u003e \u003cli\u003eDetermine adverse and serious adverse event reporting\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eMedical Directors\u003c\/li\u003e \u003cli\u003eMedical Writers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eResearch and Development Personnel\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003eCaroline Ritchie, Ph.D., M.B.A.\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer biographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375366234477,"sku":"BI17591","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/writing-clinical-study-protocols-2026-12-15","provider":"Barnett International ","version":"1.0","type":"link"}