Effectively Writing Clinical Trial Protocols

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Course Description

The basis and success of any clinical development program is the study protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol. However, there is considerable variability between companies and individuals regarding the approach to writing this critical document, even with a good understanding of ICH guidelines. Clinical trials and entire programs have failed because the protocol was not scientifically sound, and knowing how to effectively research and write a clinical trial protocol is essential to achieving IRB and ultimately market approval. Moreover, amendments, however unwelcome, are a necessary part of the development process and must be managed efficiently to avoid costly implementation or delays to the ongoing trial.

Learning Objectives

  • Improve basic writing skills, and learn the use and importance of style guides and templates
  • Differentiate between the phases of investigation for drugs and devices
  • Manage the timeline for protocols and their amendments, including internal and external review, key opinion leader input, collation, revisions, QC process, sign-off, and meetings
  • Navigate the protocol concept sheet and synopsis; using these as an outline for the protocol
  • Describe the requirements for and elements of a protocol including the hypothesis, clear and concise objectives, primary and secondary endpoints, inclusion/exclusion criteria, and the Schedule of Assessments
  • Describe adverse events and serious adverse events and their reporting, depending on type of study and type of intervention
  • Develop a basic statistical understanding (e.g., qualitative and quantitative data, sample size determination, and interim analysis)
  • Develop protocol amendments: how and when to do it and documentation needed

Who Should Attend

  • New or Intermediate Medical Writers
  • Personnel who review protocols — Medical Directors, Statisticians, Clinical Pharmacologists, Regulatory Affairs Professionals
  • Clinical Research Associates, Coordinators and Investigators
  • Non-Clinical Personnel
  • Marketing Personnel


Caroline Ritchie, Ph.D., M.B.A.

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Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Writing Basics
  • Overview of the Protocol Requirements  
  • Building the Protocol  
  • Protocol Amendments  

Day Two: 8:30 a.m. – 5:00 p.m. 

  • Building the Protocol, cont.
  • Past precedence and approved labels  
  • Constructing protocol based on research  
  • Informed Consent Form
  • Case Report Forms  
  • Protocol Amendments  

Interactive Activities

  • Development of the objectives, review of the synopsis process, and generation of a Schedule of Assessments

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 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#: 0778-0000-17-007-L01-P. Released: 3/17.


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.