On-Demand Webinar

Bridging the Gap: A Standardized Approach to Clinical Trial Document Management

As a clinical research professional, you are constantly asked to accelerate research timelines while the research itself becomes more complex and your resources become more scarce.

Luckily, we are making progress. In this webinar, representatives from the Advarra Site-Sponsor Consortium discuss a standards-based integration and automation of research technology across sites, sponsors, and CROs. The group shares the Consortium’s role in developing Secure Document Exchange and the role of standards in creating seamless process between all stakeholders.

Join us on-demand to hear perspectives from across the industry on how this collaborative, standards-based approach is key to finally addressing the challenge of automating data and document exchange across sites, sponsors, and CROs.

Learning Objectives:

  • Understand investigator site file (ISF) and sponsor trial master file (TMF) organization
  • Get a site perspective on how we can improve compliance by streamlining interactions between sites and sponsors
  • Explore existing standards for ISF and regulatory binders, and how these standards will evolve through the CDISC TMF Reference Model
  • Determine actionable steps to take for all research stakeholders to make the connected research ecosystem a success

Presented By


Dawn Niccum

TMF Reference Model Steering Committee Member; Executive Director, Quality & Compliance,
inSeption Group


Stacey Banks


Director, Research Applications

Stuart Cotter.png

Stuart Cotter

VP, Product Management

Empty Image Placeholder





Who should watch?

This content applies to research professionals representing sponsors, CROs, and institutions who are involved in clinical trial planning, development, and execution.

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit. 

This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now