Training
SFP Consulting provides team or individual training on the scientific and drug development processes (eg, CTD or NDA process), regulatory issues (informed consent), and project-specific topics (labeling). Topics include instruction and practice in preparing all of the documents mentioned under Services, especially those in the CTD. Instruction on optimizing document review processes, writing for electronic submissions, how to review statistical analysis plans, and use of contractors for writing projects is also provided.
Note: Any topics in the sessions mentioned below can also be presented separately, possibly in an expanded form as necessary. In addition, these sessions can be tailored to the needs of a specific company to include additional topics and/or to use house templates and styles.
Current offerings include (but are not limited to) the following courses:
Preparing the Clinical Sections of a CTD/eCTD
Session 1 (2 hours):
The following topics will be presented:
Brief CTD Overview
The Clinical Plan
Labeling and the Target Product Profile
ICH Guidelines Clinical
Module 2.5 Clinical Overview
Session 2 (2 hours)
The following topics will be presented:
ICH E3 Clinical Study Report
Module 5 Organization
Reference Lists
Session 3 (2 hours)
The following topics will be presented:
Module 2.7 Clinical Summary
Integrated Summary of Safety/Integrated Summary of Efficacy
Session 4 (2 hours)
The following topics will be presented:
IND to CTD Mapping
Transitioning to an eIND
Tips on Writing for Electronic Submissions
CTD Content/Process Workshops
Roundtable Review Meetings
Preparing a Clinical Study Report 4 hours
The following topics will be presented:
Using a template based on ICH E3 Guideline
Assembling a shellreport from the protocol and statistical analysis plan
Writing efficacy and safety results including selection of in-text tables
Summarizing for the discussion and synopsis
Assembly of appendices
Includes practical exercises in writing the study design and safety sections.
Writing Safety Narratives 2 hours
The following topics will be presented:
Designing and using an appropriately detailed template (using various examples or the house template)
Writing narrative text including in-text tables of laboratory, vital sign, or ECG results when necessary
Requesting data displays for use in safety narratives (eg, dates vs durations, verbatim vs coded drug names)
Includes a practical exercise in narrative writing from listings and CIOMS/MedWatch information.
Writing Clinical Study Protocols 1.5 to 2 hours
The following topics will be presented:
Preparing a protocol plan
Writing a full protocol
Amending a protocol
Includes a practical exercise in preparing a protocol amendment.
Writing for Electronic Submissions 1.5 to 2 hours
The following topics will be presented:
Using authoring templates
Using style guides/sheets
Portable Document Format (PDF) specifications
Hyperlinking processes
Quality control
Managing Contract Writers for Timely Delivery of Quality Writing Services 30 minutes
The following topics will be presented:
Why use contractor writers?
Setting up for success
Document production process
Pitfalls and tips
Innovative Roundtable Strategies Accelerate Timelines 30 minutes to 1 hour
The following topics will be presented:
Roundtable meetings
What are they?
Why have them?
Basic roundtables
Advanced concepts
Practical tips
Reviewing Statistical Analysis Plans 1.5 hours to 2 hours
How to Get Displays You Can Use to Write and Quality Check Safety Data More Efficiently
The following topics will be presented:
Reviewing statistical output for clinical study reports
Reviewing statistical output for integrated summaries
Using graphics: a picture is worth 1000 words
Providing listings specifications to support safety narrative writing:
Making a Robust Guidance for the CTD Summary of Clinical Safety and Parallel ISS: Writing Manual and Development Team Planning Tool 1 to 1.5 hours
The following topics will be presented:
Learn how to construct a robust guidance for the CTD Summary of Clinical Safety (SCS) and ISS based on ICH M4E, additional regulatory guidances, and other available information.
Explore how to use this document as a writing guide and as a tool to lead indication-specific project team discussions on CTD Section 2.7.4.