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1-8413 Documentum Life Sciences Electronic Trial Master File (eTMF) v4.1

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Duration: 2 days

The OpenText Documentum Electronic Trial Master File (Documentum eTMF) solution, part of the OpenText Documentum for Life Sciences solution suite, enables Life Sciences organizations to address the challenge of capturing, collating, storing, securing, and retaining massive amounts of documents from clinical studies conducted at numerous sites and countries around the world. Documentum eTMF, built on Documentum, is used in enterprise-scale information management applications in Life Sciences and supports TMF management in conformance with the latest industry standards.

The Life Sciences Electronic Trial Master File course is designed to train key business users and business administrators in the core functionality of the solution so they may help to refine system requirements, perform system evaluation testing, and assist in the training of end users.

With this solution, you can:

  • Plan your TMF for clinical trials based on predefined file plan templates
  • Provide placeholders for clinical document authors, study monitors, and other participants to find, upload, and create content
  • Bulk-upload existing or externally-produced documents, such as documents delivered by external Contract Research Organizations (CROs)
  • Obtain document metadata automatically to facilitate search and discovery and to reduce the need for manual data entry
  • Use predefined review and approval workflows, electronic sign-off, and secure auditing to enable 21 CFR-11 compliance
  • Monitor the progress of clinical trials globally
  • Facilitate Inspection-Readiness through collection, completion, and missing document reporting on Products, Trials, and Sites
  • Manage access to trials based on user roles
  • Integrate the solution with your Clinical Trial Management System (CTMS) in order to synchronize CTMS-controlled information with your Documentum eTMF system

On completion of this course, participants should be able to:

  • Explain the features and benefits of Life Sciences TMF
  • Describe the scope of the solution
  • Describe registration forms
  • Search for documents
  • Create documents
  • Create and manage a file plan
  • Import and index documents
  • Route documents for collaboration, review, and approval
  • Run reports
  • Manage external participants
  • Perform application configurations

Delivery Options:

  • Instructor-led
    • Public: See scheduled public classes below
    • Private: Email Us for information on how you can arrange a private class.

Prerequisites

Pricing

Format Currency Price
Per Student at OpenText Site USD  1,790.00 
Per Course at Customer Site USD  9,000.00 

Taxes: All prices exclude VAT or other taxes where applicable (all currencies).

Extra expenses: Customer site course prices do not include instructor travel expenses, which are billed separately.

Reservations: Please provide a minimum of 3 weeks advance notice when arranging courses at customer sites.

Course & Workshop Calendar

Currently, there are no training dates scheduled for this course or workshop at this time. Please contact us to schedule an on-site course or workshop at your location.