Topic: Clinical Study Protocol

Podcasts

The Importance of Getting Clinical Study Protocols Right
Episode 14: The Importance of Getting Clinical Protocols Right

In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will help ensure teams are following these, looking for ways to handle the ever more complex studies that are being designed, the importance of focusing on the regulatory objectives of a study over more academic pursuits, the value of using the Transcelerate template to get more standardization across the industry, and the importance of preparing protocols that communicate clearly and effectively not only to help users find the information they need but also to ensure teams are aligned on the full intentions of the study and for downstream use of the protocols in writing study reports and ultimately dossiers.

Publications

Clinical Study Protocols
Clinical Study Protocols: The Pillars of Clinical Development
Welcome to the 2023 Medical Writing Supplement developed as a collaboration between Samedant Ltd and Trilogy Writing & Consulting and published as part of the Winter edition of International Clinical...
Journal: Medical Writing Supplement of International Clinical Trials, ICT
Date: February 2023
H1-Journal-Front-Page
Reaping the Benefits from Improved Clinical Study Protocols
Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Not only do they lay down the plan for the study at hand, they serve as a repository of knowledge for the strategic intentions and will be used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and will be used by participants, ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers to appraise the study.
Author: Julia Forjanic Klapproth
Journal: H1 Virtual Events: Review and Summary Handbook
Date: June 2021
Medical-Writing-Cover-722x1024
Streamlining Clinical Study Protocols and Reports
Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment. This article...
Author: Julia Forjanic Klapproth and Sam Hamilton
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2017
12_Words of Wisdom-Protocol Writing_Julia Forjanic Klapproth_ICT_Aug 2013_Thumbnail
Words of Wisdom: writing Protocols
The ABCs of writing effective Clinical Study Protocols
Author: Julia Forjanic Klapproth
Journal: International Clinical Trials, ICT
Date: August 2013