Archives du mot-clé INCDMA

INCDMA – Reports 2014


Dear all

Lots of critical topics for discussion tomorrow. Please plan to attend as your schedule permits – or provide written updates at earliest convenience, since for some of the deliverables (such as our March webinar) we are now on a critical path.

1.       Most urgent: PSDM/INCDMA eSource webinar #2 (follow-up from the 2012 ACDM/INCDMA one). Abstract/invitation is finalized – the list of panelists is also being weeded out. Martijn has kindly sent out the initial announcement . The LinkedIn group is updated. Please disseminate this announcement vigorously among your own local professional associations and DM networks.

2.       eSource SCDM white paper. An initial contact was established with the writing team. The INCDMA committed to help in any way possible (direct contributions to the paper and dissemination).

a.        An deadline for Thursday 06 Feb to provide comments has passed but currently unsure if any pertinent comments have been received or when the first version of the paper is due to be released.  (SusanBegona to provide an update?)

b.       Japan DIA eSource Workshop was a success. They are also looking out for the SCDM white paper (Yumi to provide oral or written update when possible).

eSource was not main theme focused on at the session where Ron made presentations. The main topic is electronic submissions of standardized study data.

Here is the link of task force specialized in e-submission of clinical data at PMDA.

We also had the round-table discussions among FDA, PMDA and Pharma industries.

 3.       Support for the ACDM upcoming conference (Ian, Eva, Erica)

4.       Subsequent webinar for the year (Risk Based Monitoring follow-up): The minutes from last year’s webinar have been (finally J) drafted. After obtaining initial feedback from the panelists they can shared within this group for additional comments and could be used in the promotion material of the Autumn RBM Webinar #2.

Please provide standing items (such as the Wikipedia entry, INCDMA budget & website set-up etc.) or anything further that you deem appropriate for this forum as walk-ins during.

Best regards


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Japan Guidance for Risk-Based Monitoring – July 2013