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

Investigator Site File System Assessment V2024 Handbook and Questionnaire

Investigator Site File System Assessment V2024 Handbook and Questionnaire

ISF Assessment Handbook and Assessment Questionnaire: Version 2024

This is the ONE FILE that you need to perform an assessment of your Investigator Site File system.

- Sites should complete an ISF Assessment to self-assess any site-supplied computerized file system that could originate or handle electronic records that are part of a clinical research study to determine it's suitability for this.  The questionnaire is based on regulatory authority expectations.

- Download the Handbook file and save to your computer. The instructions for completing the questionnaire are in section 3, and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors. One completed assessment can be sent to all of a site's sponsors.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org. 

TO DOWNLOAD THE HANDBOOK & SITE FORM (ONE FILE), CLICK ON THE LINK UNDER "DOCUMENTS TO DOWNLOAD" BELOW.

Documents to download

Print
Categories: eSRA
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)
«May 2024»
MonTueWedThuFriSatSun
2930
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
1
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
2
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
345
6789101112
13
13/05/2024

Assessing Investigator Site File Systems for Clinical Research

A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more".

Read more
141516171819
20
Japanese translation of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1 (20-May-2024)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Read more
212223242526
272829303112
3456789

Upcoming events Events RSSiCalendar export