Discover the course

ONLINE TRAINING: Clinical Study Reports – a 360° Perspective

Planning and authoring CSRs in accordance with public disclosure requirements.

Date

19 and 21 October 2020

Location

Online

Language

English

ONLINE TRAINING: Clinical Study Reports – a 360° Perspective

This virtual course in 2 sessions covers scheduling, managing and authoring of clinical study reports (CSRs) for modern design clinical studies. It discusses the stages of preparation of CSRs in the context of precursor documents including the clinical study protocol (CSP), the statistical analysis plan (SAP), and the incorporation of study data. Components of the integrated CSR include narratives and appendices, and the preparation of these sections of the CSR will also be covered. Scheduling an achievable reporting timeline for this complex and multi-component document will be explained. 

The practical use of CORE Reference for writing integrated CSRs is demonstrated. Open access CORE Reference (www.core-reference.org/) launched in 2016, provides interpretational guidance on CSR authoring that incorporates ICH, regional (EU and US) guidances and real-world insights. CORE Reference helps writers to author CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. 

At the end of this course participants should understand the resources and have gained the knowledge to schedule, manage, write and deliver draft through final version CSRs that are of the highest quality, and are fully ICH compliant. By completing the course, participants will also gain insight into the public disclosure requirements that a CSR must fulfil.

MODULE 1 

General Introduction 

  • Meeting agenda
  • Getting to know each other 

Part 1: Process Overview, Components and Stages of Preparation of the Integrated CSR

  • Background and Overview of CSR Writing
  • Shell CSR
  • Draft CSR
  • Final CSR

Part 2 

  • CSR Appendices
  • CSR Narratives
  • Overnight quiz


MODULE 2

Part 1: CSR Authoring Using a ‘State of the Art’ Tool

  • Quiz answers
  • Introduction to CORE Reference
  • CORE Reference web tour www.core-reference.org
  • Common areas of confusion in ICH E3 – group discussions

Part 2 : CORE Reference: ‘CLARITY’ in clinical study reporting

  • How CORE Reference solves inconsistencies in areas of ICH E3 confusion; selected examples 
  • CORE References appendices and annexes
  • Added value – results posting efficiencies

Part 3 : CORE Reference ‘OPENNESS’ in clinical study reporting

  • Transparency and disclosure environment
  • Public disclosure requirements
  • CORE Reference approach
  • EMA, Health Canada - publicly disclosed CSRs
  • Changing concepts and culture

Part 4: Close

  • Closing remarks; are expectations met and any remaining questions not covered through the modules 
  • Feedback forms reminder


Course Language

The online training will be in English

Sam Hamilton
Sam Hamilton Subject Matter Expert in Regulatory Medical Writing

Sam Hamilton is a postdoctoral virologist, currently Global Head of Medical and Regulatory Writing and Public Disclosure for the CRO, Clinipace www.clinipace.com. Sam has over 25 years in clinical and regulatory medical writing roles in the pharmaceutical industry and is an expert in writing and managing clinical-regulatory documentation for medicines licensing. Sam is an internationally recognised expert and speaker in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered open-access www.core-reference.org in May 2016. Sam is long-time supporter of her professional association, the European Medical Writers Association (EMWA) www.emwa.org serving in various roles over 12 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW) (journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Lifetime Fellow in 2018 for her services to the association. Currently, Sam is MEW Section Editor for the “Regulatory Public Disclosure” Section and serves on the Advisory Panel of the EMWA Regulatory Public Disclosure Special Interest Group.

Regulatory medical writers working in the contract research organisation or pharmaceutical company environment who write or review clinical study reports (CSRs). Medical writing managers who oversee regulatory medical writers and who wish to ensure that they are incorporating industry standards into their regulatory writing process would also benefit from attending. Participants will be expected to complete a ‘needs analysis  ’ form prior to the course to provide the course leader with insights to allow for an optimal teaching and learning experience.


Participant experience

Participants must have written at least one CSR or reviewed several and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.

This online course will be highly interactive with discussion and questions encouraged throughout the two virtual sessions. In each session there will be an opportunity for participants to actively participate. Participants are asked to bring a hat or cap to the sessions to facilitate their on-screen participation.

Online interactive training on Zoom platform.

Online Training - 2 modules

October 19th, 2020            2:30 pm – 5:30 pm CEST

October 21st, 2020             2:30 pm – 5:30 pm CEST


After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird€ 720,00* (until 28 September 2020)

Ordinary€ 830,00*

Freelance - Academy - Public Administration**€ 430,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

830.00 €

Early Bird

Monday, September 28, 2020

720.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules (3 hours each)

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Demonstrate the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena

  • Understand the stages involved in authoring CSRs allowing you to make a valuable contribution to your organisation’s process improvement activities

  • Be better equipped to manage stakeholder expectations with regard to efficient, effective and realistic CSR scheduling

Participants' Feedbacks

Practical and clear explanations

Practical evaluation of how to approach risk analysis

Very practical and constructive - readily helpful

You may also be interested in

No linked courses suggested

Close Menu
×
×

Cart

ONLINE TRAINING: Clinical Study Reports – a 360° Perspective

information request

Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

Information collection and use
In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.