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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 5 Track 3 - Connection with CROs

Session Chair(s)

Michelle L. Charles, MPH

Michelle L. Charles, MPH

Director, Regulatory Affairs, Gene Therapy Program

University of Pennsylvania, Perelman School of Medicine, United States

More often than not, sponsors are working with CROs to execute programs, trials, or functional tasks. This session will bring varied scenarios of CRO responsibilities and technology interaction. Data and documentation at clinical sites has long been a collection of paper, electronic, and portable digital mediums. Ensuring the completeness and quality of the site records has traditionally involved on-site monitoring model, but the size, complexity, and number of clinical trials mean that complete on-site monitoring is becoming an ineffective, expensive, and inefficient process. Alternate methods for remote monitoring will be explored. In addition, how can essential document management be utilized to enable CRO accountability and what are the best options to ensure compliance? Is there a benefit to both a sponsor and a CRO maintaining separate eTMFs? Is it too much of a good thing? What are industry and compliance driven best practices for a dual system model.

Learning Objective : •Discussion on Regulations for Clinical Monitoring •Practical difficulties/issues faced by sponsor/CRO, during monitoring : Case Studies •How to formulate most efficient monitoring plan •Execution of remote monitoring in flexible manner, despite achieving purpose of monitoring


Ashok  Ghone, PhD

Implementing Risk Based Monitoring Approach to Clinical Trials

Ashok Ghone, PhD

MakroCare, United States

VP, Global Services

Kelley  Robinson

Essential Document Management - Using Metrics to Drive Compliance and Provide Oversight

Kelley Robinson

Pfizer, United States

TMF/Registry Process Analyst

Paul  Nalepa

eTMF – Options for the Sponsor When Working With A CRO

Paul Nalepa

PPD, United States

Assoc. Manager, Information Governance & Compliance, Global Quality & Compliance

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