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Webinar | Record-keeping, Document Ownership and Control, and Inspection and Privacy

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Description

Essential Components of a Clinical Trial Agreement | Webinar Series

The entire purpose of a clinical trial is to generate a record of the safety and efficacy of the drug or device being evaluated. The record is key to FDA approval, clinical director for use, and often times, a central issue in many types of litigation - from IP disputes to mass torts related to adverse effects.

Clinical trials generate a large amount of data and documentation that must be properly managed, stored, and protected throughout the study and beyond. This webinar will provide an in-depth analysis of the best practices and regulatory requirements for record-keeping, document ownership and control, inspection, and privacy in clinical trial contracts.

Learning Objectives:

  1. Identify and classify the essential documents for clinical trials and understand their purpose and function.
  2. Apply the best practices and regulatory requirements for managing, storing, and protecting clinical trial data and documents.
  3. Prepare for and handle audits and inspections by regulatory authorities or sponsors.
Knowledge Level: All Levels

Registration
(Deadline April 17)
Late Registration***
(After April 17)

Individual Registration
Member Rate* $99 $114
Non-Member Rate $165 $180
Group Registration**
Member/Non-Member Rate $350 $365

Register for the entire Webinar Series for one low rate!

Registration includes access to the live event, PowerPoint slides, and complimentary access to the On-Demand version for 30-days.
*To receive the member registration rate, you must an SRAI member during the event.
**All Group Attendees must be added when registering. Up to 12 attendees per group.
***If registering late, please contact registration@srainternational.org for assistance.

Online Registration
(Credit Card Payments Only)
  • Click the blue Register button to register for the Webinar
  • Login with your member account or sign up as a first-time visitor
  • Follow the registration instructions and proceed to check out
Full payment must be received prior to the start date of the event. If you have any questions regarding your registration, please contact registration@srainternational.org.

Policies:
Written requests for registration refunds must be postmarked on or before April 11. Cancellations submitted on or before April 11, less a $25 meeting cancellation fee. If you paid membership dues while registering, these will not be refunded; only the actual registration fees will be refunded less the cancellation fee(s). No refunds will be made after April 11. Refunds are not given for no-shows. Registration substitutions from the same institution are accepted; membership substitutions are NOT accepted. All fees will be reimbursed if the program is cancelled. In the case of a cancellation, you will be notified by SRAI from srameetings@srainternational.org.

Registration: We cannot process any advance registration forms without full payment. Invoices will NOT be issued. Purchase orders are NOT accepted. You must be a Full Member of SRA International at the time of the program to receive member rates.

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Privacy Policy: SRA International privacy policy can be found at www.srainternational.org/privacy. For questions email us at communications@srainternational.org.

Contributors

  • Debra Parrish, Partner, Parrish Law Offices, LLC

    Ms. Parrish is an attorney who works with academic medical centers, research institutions and companies, particularly those in the life sciences area in the United States. Her areas of legal concentration are science law (including research misconduct, regulations, compliance and investigations), health care law, and intellectual property. Ms. Parrish previously worked at the Office of Research Integrity as an attorney and now counsels journals, institutions and scientists on matters of research integrity. She is a frequent speaker and author on research integrity issues and has worked on some of the most high profile and complex cases over the past 25 years. In March 2016 she served as an invited panel member on research integrity issues at the National Academy of Sciences. She received her law degree and bachelor of science in biomedical engineering from Duke University and is a member of the patent bar.

  • J. Michael Slocum, JD, President, Slocum & Boddie, PC, SRAI Distinguished Faculty

    Mr. J. Michael Slocum is a principla of the law firm of Slocum & Boddie, PLLC. He has over twenty years of experience in grant and contract law.

    Mr. Slocum has worked with organizations such as SRAI, Texas A&M University, the University of Mississippi Medical School, the University of Cincinnati, the National Council of University Research Administrators, the Departments of Defense, Agriculture, Interior, Health and Human Services, the General Services Administration Office of Acquisition Policy and the Federal Computer Performance and Evaluation Center (FEDSIM). Mr. Slocum has provided high quality training in all aspects of government contracting and grants management, private contract and grants issues, clinical research contracting, negotiation, and other legal and business issues. In addition, he and his firm have provided detailed expert review of federal, pharmaceutical and other contracts as well as other legal documents. Mr. Slocum and his firm have also written clear and comprehensive texts, manuals, and handbooks for public and private organizations and assisted in developing negotiation strategy and litigation positions.

    Mr. Slocum has advised and trained universities, non profit organizations, hospitals, Federal agencies and private businesses. He has conducted internal reviews and investigations of universities and private corporations. He has participated in hospital system reviews of research operations and infrastructure and in the development of a new research administration function for a major foreign university. During his career he has conducted thousands of training courses and seminars and has written many texts and training manuals.

    Mr. Slocum has been recognized by the Society of Research Administrators International as a Distinguished Faculty member, Excellence Award winner (2003) and Hartford-Nicholson Award winner (1992). He presently serves as counsel to SRAI and is a member of the Conflict of Interest committee. 

April 18, 2024
Thu 2:00 PM EDT

Duration 1H 0M

This live web event has ended.

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