DatStat Online Seminars

Surviving an Audit – Compliance vs. Validation

Held November 20, 2013

Presenters:

David Nettleton

David Nettleton, Computer System Validation

Renee Petrie

Renee Petrie, DatStat

David Nettleton
Founder & Consultant
Computer System Validation

Renee Petrie
Sr. Director, Healthcare Solutions
DatStat, Inc

Overview:

It’s time for an FDA audit. Will your site pass the test?

Clinical trial sponsors need to know that each of their sites is operating according to protocol, GCP, and FDA requirements. Likewise, sites and CROs interested in attracting new studies must demonstrate their ability to meet these requirements. Validation is the only way that all parties can be assured that trials are fully-compliant and able to withstand an audit.

David Nettleton, author and FDA compliance expert, detailed the 10-step process used to validate computer systems used in clinical trials and explained the roles that vendors, sites, and sponsors must play in the process. Renee Petrie of DatStat discussed how the validation process supports the drive to reduce study duration and lower costs.

Key topics

  • Understanding 21 CFR Part 11 vs GCP
  • Security requirements for EDC/CTMS software
  • ROI of compliance and validation
  • Beyond software – other requirements for validation
  • Roadmap for compliance

DatStat overview

Following the session, participants were invited to participate in an overview of the validated EDC/CTMS technology and services provided by DatStat.

Who Attended
  • Clinical research sponsors
  • Research coordinators
  • Principal investigators
  • Research assistants
  • Clinical research professionals
  • Clinical Trials Office staff
  • Shared resource and core facilities staff
  • Electronic data capture (EDC) or informatics professionals
  • Current/prospective DatStat clients
Info sheet

One-page PDF info sheet about this session, for printing and sharing with colleagues

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Improving Your Grant Applications – Tips for peer review and data management

Held August 6, 2013

Presenters:

Drs. Elizabeth (Lizza) Miller and Joy Gibson

Drs. Miller and Gibson

Joy Gibson, Ph.D. (Retired)
Director, Division of Translational and Clinical Sciences
Center for Scientific Review

National Institutes of Health

Elizabeth (Lizza) Miller, Ph.D.
CEO and co-founder
DatStat, Inc

Overview:

Research funding seems to be more limited than ever, so it’s important to give yourself every advantage when submitting a new grant application. Watch this video for expert advice from two Ph.D.-level researchers, including a former review director at the NIH’s Center for Scientific Review, with nearly 50 years combined experience.

Key topics

  • Overview of the peer review process at NIH
  • Do’s and don’ts for grant applications
  • Types of grant opportunities, such as the Pioneer Award
  • Overview of data management strategies
  • Top 3 supporting documents for your application

Who attended

  • Research coordinators
  • Principal investigators
  • Research assistants
  • Clinical research professionals
  • Clinical Trials Office staff
  • Shared resource and core facilities staff
  • Electronic data capture (EDC) or informatics professionals
  • Current/prospective DatStat clients

Info sheet

One-page PDF info sheet about this session, for printing and sharing with colleagues

Earlier Seminars