The Association of Clinical Research Professionals

Webinar Replay: Best of ACRP 2019 – Inspection Readiness – Beginning with the End in Mind

Pricing With Contact Hours

Member: $15 | Nonmember: $75

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires November 11, 2020.


Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay Expires November 11, 2020.


Speakers:

  • Donna Dorozinsky, RN, MSN, CCRC – Barnett

Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection.  The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection.  The key to a successful inspection is preparing at the start of the study.  Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day.  The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.

Upon completion of this Webinar, attendees should be able to:

  1. Identify 4 strategies for ensuring that their organization is inspection ready through-out the life of the study
  2. Identify 2 current trends in health authority inspections of both the investigator site and the sponsor/monitor organization
  3. Identify 3 techniques for ensuring that their study documentation tells the story of the study