Research Administration 101: Best Practices for your Clinical Trials Office - Society for Clinical Research Sites – SCRS
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Research Administration 101: Best Practices for your Clinical Trials Office

$545.00 (Non-Member Price)
$0.00 (SCRS members – Included as member benefit, no additional cost)

Archived webinars do not provide contact hour credits.

Course Description
Research administration is an important part of the clinical trials processes. Developing study budgets, negotiating contracts, and performing coverage analyses are all specialized tasks that require specific training and practice. If done effectively, these processes can save your institution time and money, in addition to ensuring billing compliance. Join research administration experts from PFS Clinical for a 5-part webinar series on the following topics:

  1. HIPAA for Research
  2. Coverage Analysis for Drug Studies
  3. Coverage Analysis for Device Studies
  4. Budgets
  5. Contracts

MODULE 1
June 15th: HIPAA for Research
Speaker: Marilyn Windschiegl

The Health Insurance Portability and Accountability Act (HIPAA) is one of the most important legal and ethical guidelines in healthcare today. While it is crucial for any establishment dealing with health information to be HIPAA compliant, it can be a tricky topic to understand, particularly in the context of clinical research. In this webinar, Director of Clinical Research Contracts and Compliance Marilyn Windschiegl will discuss topics such as HIPAA vocabulary, research that is covered by HIPAA, and research uses and disclosures that are governed by HIPAA.  Additional topics such as waivers of authorization, the Minimum Necessary Rule, and limited data sets will also be covered.

MODULE 2
June 29th: Coverage Analysis for Drug Studies
Speakers: Liz Christianson, Taylor Wagner

Understanding and applying reimbursement guidelines is one of the most challenging aspects of clinical research administration. Between institutional review boards, informed consent practices, Medicare guidelines, and national/local coverage determinations, the list of administrative considerations is daunting. Join Senior Clinical Research Analysts Liz Christianson and Taylor Wagner as they discuss the importance of coverage analysis, general ideas and interpretations of regulations, proper citations for coverage analysis, and how to qualify a clinical trial for coverage.

MODULE 3
July 13th: Coverage Analysis for Device Studies
Speakers: Nicole Bruecker, Jake Meyer

Completing a coverage analysis can be a complex and tedious process. However, doing so can ensure your institution maintains billing compliance. It is important to understand that the coverage analysis process for device studies is different from the steps taken for a drug study. In this webinar, Senior Clinical Research Analysts Nicole Bruecker and Jake Miller will discuss Medicare coverage for investigational devices, FDA device approval types, documents required for performing a device coverage analysis, and special considerations for device studies.

MODULE 4
July 27th: Budget Basics
Speaker: Amanda Miller

Budget development and negotiation for clinical trials is often a lengthy process of back and forth redlining, frustrating calls and emails, and confusing payment terms. At the same time, there are many benefits to implementing a thorough budgeting process. In this session, Training Program Manager Amanda Miller will share her budgeting secrets, break down the process, review effective and efficient negotiation, and demonstrate the common pitfalls using case studies and real-life examples.

MODULE 5
August 10th: Contract Basics
Speaker: Jody Ingebritsen-Howe

Reviewing and negotiating clinical trial agreements (CTAs) can be a highly complicated endeavor, and poor negotiation of those CTAs can expose research institutions to significant legal and financial risk. This problem can be further exacerbated by insufficient staff, lack of expertise, and demanding study start-up timelines. Join Clinical Research Contracts and Compliance Manager Jody Ingebritsen-Howe as she discusses the basics of contract drafting, common contract traps, and negotiation tools.

Please note: SCRS will send out connection info the morning of the webinar.

 

Society for Clinical Research Sites, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

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To obtain your Contact Hours for this webinar:

  1. The webinar must be watched in its entirety.
  2. The post webinar survey immediately following this webinar must be completed in its entirety.
  3. Your contact hour certificate will be sent to you within 30 days of you viewing this webinar.
  4. The contact hour certificate will be sent to the email address provided when you registered.

Planners, presenters, faculty, authors, and content reviewers do not have any relevant financial relationships with any commercial interest.

This webinar does not imply any endorsement of products or services by the Society for Clinical Research Sites or ANCC.

The materials and recording of this webinar will be available for one year as an archive, but will not award any contact hours.