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BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Offered twice: Wed March 14 2018 for one hour at UCT 0800 and UTC 1700

Event date: 3/14/2018 Export event

BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Facilitated by Cinzia Piccini, Eli Lilly & Co

According to ICH E6, direct access should be granted to regulatory inspectors to examine, analyze, verify and reproduce any records and reports that are important to evaluation of a clinical trial. What are the considerations and challenges to grant such access in the Sponsor’s systems (e.g. eTMF, EDC, eCRF, ePRO, IVRS…)? Are there different approaches according to the type of systems (on-line/off-line), locations of the inspection (site vs. sponsor vs CRO)?  What should sponsor expect from regulatory inspectors (e.g. being trained, hardware/software configurations etc.). Participants are encouraged to share their ideas and experiences!!  

Time: This BoF is offered at 2 times in order to accommodate eCF members from around the world:  March 14 at UTC 0800 and March 14 at UTC 1700

This BoF Discussion is open to all from eCF Member companies. Please contact suzanne.bishop@eclinicalforum.org to register for this BoF or for information on eCF membership.  If you are not a member and would like more information on all the eClinical Forum member benefits, see the membership tab on this site or contact info@eclinicalforum.org and we will be happy to set up a phone meeting to discuss how your organization might fit with eClinical Forum.

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«May 2018»
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5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

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5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

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3
5/1/2018 - 5/3/2018 UTC
43

North America Spring Meeting May 1-3 2018 -- Agenda

This meeting is open to industry, healthcare, academic and government partners who are members of the eClinical Forum. Please contact  info@eclinicalforum.org to discuss membership options. Click on title to download Preliminary Agenda.

 

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1415
5/15/2018 - 5/17/2018 UTC
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Agenda for European Spring Meeting, 15-17 May 2018

The agenda is available for our Spring meeting being held at Merck in Darmstadt, Germany on 15-17 May 2018

This meeting is open to industry, healthcare, academic and government partners. Please contact us to discuss membership options.

If you haven’t already registered then Please register for the eClinical Forum meeting here  (https://www.surveymonkey.com/r/2018_Darmstadt)

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16
5/15/2018 - 5/17/2018 UTC
44

Agenda for European Spring Meeting, 15-17 May 2018

The agenda is available for our Spring meeting being held at Merck in Darmstadt, Germany on 15-17 May 2018

This meeting is open to industry, healthcare, academic and government partners. Please contact us to discuss membership options.

If you haven’t already registered then Please register for the eClinical Forum meeting here  (https://www.surveymonkey.com/r/2018_Darmstadt)

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17
5/15/2018 - 5/17/2018 UTC
44

Agenda for European Spring Meeting, 15-17 May 2018

The agenda is available for our Spring meeting being held at Merck in Darmstadt, Germany on 15-17 May 2018

This meeting is open to industry, healthcare, academic and government partners. Please contact us to discuss membership options.

If you haven’t already registered then Please register for the eClinical Forum meeting here  (https://www.surveymonkey.com/r/2018_Darmstadt)

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