WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Thurs, 21-Sept-2023

Event date: 21/09/2023 Export event

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Date:  Thurs, 21-Sept-2023      Duration: one hour

Facilitators:    Jun Zhao, Yanan Hu, Ying Huang, Boehringer-Ingelheim         

Open To: Staff from eClinical Forum member companies gratis FOLLOW THIS LINK TO REGISTER:   eCF Birds-of-a-Feather: Audit Trail Review Tools (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 )

Background: eClinical Forum  Birds-of-a-Feather 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:   The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.

Note – in April 2021, the eCF, joint with SCDM, released a public white paper on this topic, that can be downloaded at Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org)

Time – We apologize for the inconvenient time in some time zones. We will be recording this session, so please also register if you would like a link to the recording.

 

Print
Tags:
Rate this article:
No rating

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«July 2024»
MonTueWedThuFriSatSun
242526
eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

Read more
27282930
12
eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

Read more
345
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

Read more
67
891011121314
15
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

Read more
161718
eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.

Read more
192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export