Electronic Signatures in Clinical Trials – EUCROF Webinar
September 25 – 11am – 12:30pm CEST
•The meeting will start at 11.00AM o’clock.•Audio is available either through your computer or through phone connection (dial-in).•Your line will be kept on mute.•At the end, there will be time for questions and you can submit your questionsthrough the ‘question’ box.•After the webinar, connect to the EUCROF eLearnIN platform (https://eucrof.eu)to retrieve materials, customer satisfaction survey and certificate of attendance.•At the end of the webinar, a Forum Discussion will be opened on the eLearnIN platform (https://eucrof.eu) to ask further questions to the speaker or start an open discussion on the topic of the webinar.
Overview
With the pandemic it became apparent that we use electronic signatures on documents very often. Staff had to stay at home and the home office was even a requirement in some countries. Printing, signing, scanning, mailing the documents for approval and sending the originals with postal mail is tedious. On the other hand the electronic signature systems offer the possibility to sign with a click. This sounds great and it has been widely used without further ado.
But once you look into a TMF you will find a complete chaos regarding signatures: wet ink scans mixed with different electronic signatures.
This presentation shall give an answer to the following and more questions:
- What is a valid and compliant signature?
- Which regulations do I have to follow?
We need a pragmatic and compliant approach for signing and filing documents with electronic signatures.
Presenter: Dr. Marc Eric Brooks
Marc Brooks is the founder and general manager of elderbrook consulting GmbH in Tägerwilen, Switzerland and Partner of QAN Quality and Audit Network GmbH in Hamburg, Germany. The services of elderbrook consulting are focused on quality management relating to the use of electronic solutions in clinical trials for the pharmaceutical and medical device industry, e.g. audits, training, consulting, writing SOPs, and validation management. This covers not only topics such as IT security, Data Privacy, and Computer System Validation, but also all processes relating to data acquisition.
The idea of QAN Quality and Audit Network is to use our experience and network to offer support for the pharmaceutical-, biotech-, medical device and CRO industry by conducting audits, mock inspections, inspection support, gap analyses and development of quality management systems.