Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90-Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Good documentation practices can make or break a clinical trial’s success. The saying goes, “if it is not clearly documented, it did not happen.” The revision of ICH E6 GCP (R2 Addendum) brought with it some updates to GCP definitions that provide very important clarity. Among those are descriptions of good documentation practices related to what constitutes quality study regulatory and subject source documentation, irrespective of the type of media used. Site documentation practices have significant variability in the interpretation of what is required as acceptable, (e.g., providing the sponsor with the original source document vs. a copy). Even so, not everything in the updated Guideline is clear.

LEARNING OBJECTIVES

Come to this 90-minute, interactive live session and you will:

  • Receive a checklist to assess the adequacy of documentation.
  • Practice applying ALCOA-C to paper and electronic documentation in the post ICH GCP E6 (R2) world.
  • Identify methods to assess quality documentation to support inspection of clinical trials, no matter the media.
  • Recognize appropriate ways to address deficiencies in documentation.

Who Should Attend

WHO SHOULD ATTEND

This course will be valuable to anyone working in clinical trials.  Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles.  Additionally, this session will be of value to senior management and those who work in regulatory affairs, plus anyone who is affected by the quality of trial performance.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

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