How to Write an ICH-Compliant Clinical Study Report

Instructor: Robert S Hoop
Product ID: 701386
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2009

Training CD / USB Drive

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Read Frequently Asked Questions

This Clinical Study Report webinar/training is designed to provide guidance for producing such a document, included are the outline format, concepts, guidance for text, and guidance for the appendices.

Clinical Study Reports (CSR) submitted to regulatory bodies in the drug development process must meet high quality scientific standards and be compliant with International Conference on Harmonization (ICH) standards. This webinar is designed to provide guidance for producing such a document. Included are the outline format, concepts, guidance for text, and guidance for the appendices.

Areas Covered in the seminar:

  • Advice about BS, ethics, scientific interpretation, the expertise of regulatory bodies, and the problem of multiple writers.
  • What is ICH; ICH guidance, a template.
  • Synopsis and abbreviations.
  • Introduction, ethics, and administrative sections,Objectives and administrative plan.
  • Subjects, data sets, and baseline data, In-text tables and repetitiveness.
  • Efficacy results, Pharmacokinetic results, other results & Safety results.
  • Discussion/Conclusion.
  • Appendices.

Who will benefit:

  • Writers who want to become regulatory submission writers in the pharmaceutical or device industry
  • Medical writers with a little experience in regulatory writing and who want to improve
  • Medical (MD, PharmD) experts who write sections of CSRs
  • Regulatory experts who want to enhance their ability to review and approve draft CSRs

Instructor Profile:
Robert S Hoop, MPH, is the owner and president of Robert S Hoop, Inc., a pharmaceutical consulting corporation in the San Francisco Bay Area. Hoop has specialized in the pharmaceutical clinical trial business since 1982 having previously worked for 3 international pharmaceutical companies and one international CRO. He has authored 6 peer-reviewed manuscripts and made presentations at 10 professional conferences. He has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials. Hoop has been given multiple awards for the quality of his oral presentations.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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