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Event date: 16/03/2021 Export event
Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”
Date: Tuesday, 16-March-2021 Duration: One hour
Presenters: Yumi Sugiura, Bristol-Myers Squibb and Jules Mitchel, Target Health
Open To: Staff from 2021 eClinical Forum member companies gratis
Background: eClinical Forum webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic: Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.
Time – this webinar is offered at 2 times (UTC 08:00 and UTC 16:00), both on Tuesday, 16-March-2021. We hope you will find one of them convenient for your participation.
Registration -- eCF members, please contact suzanne.bishop@eclinicalforum.org. If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org
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