eCTD / RPS Discussion Forum

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admin — Thu, 10 Jun 2010 13:26:00 -0400

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eCTD / RPS Discussion Forum

RPS 101 Audio Conference Presentation – 07/21/2009

Wed, 22 Jul 2009 11:45:12 -0400

Here is the presentation from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Tuesday, July 21, 2009. If you have any additional questions, please post them to the Forum and a member of Octagon’s Regulatory Affairs Team will respond accordingly.

eCTD / RPS Discussion Forum

Notes from Audio Conference 07-16-2009

Mon, 20 Jul 2009 10:10:09 -0400

Here are the notes from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Thursday, July 16, 2009.

eCTD / RPS Discussion Forum

FDA Website Navigation Help from Octagon Research Solutions, Inc.

Tue, 02 Jun 2009 14:22:42 -0400

The FDA has recently redesigned its website and we realize that new website navigation can create additional challenges during your busy day. In order to minimize these issues, we have complied this series of relevant links to help you search more quickly for important information. Please feel free to bookmark these links for future reference.

All CDER Guidances on Electronic Submissions:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidanc...

eCTD Specs, Guidances and Checksums:

eCTD / RPS Discussion Forum

Notes from Audio Conference 05-27-2009

Mon, 01 Jun 2009 20:27:54 -0400

Here are the notes from Octagon’s eCTD/RPS Discussion Forum Audio Conference on Wednesday, May 27, 2009.

eCTD / RPS Discussion Forum

Submission of SAS Version 5 xport files to CDER

swaring — Thu, 02 Apr 2009 16:54:11 -0400

How do organizations handle the 200 character limit of character data in SAS Version 5 when submitting non-CDISC SAS xport files to FDA? Is the automatic truncation of the fields acceptable? Thanks!

eCTD / RPS Discussion Forum

Notes from Audio Conference 2-19-09

Thu, 26 Feb 2009 16:33:13 -0500

Here are the notes from Octagon’s eCTD/RPS Discussion Forum Audio Conference on February 19, 2009.

eCTD / RPS Discussion Forum

new topic

admin — Tue, 10 Feb 2009 12:48:14 -0500

tew

eCTD / RPS Discussion Forum

ViewPoint FUSE ®

admin — Fri, 06 Feb 2009 11:39:47 -0500

Better Data Faster

ViewPoint^® FUSE is an integrated EDC software platform which is unique to the industry. It is comprised of a series of reusable eCRF screens that are fully validated with complete validation checks/display rules.

eCTD / RPS Discussion Forum

EMEA eCTDs

chrisbuckley — Fri, 12 Dec 2008 16:56:05 -0500

When does the EMEA plan to accept eCTAs in eCTD format? I attended the EU EDC DIA conference last week but learned only marketing authorizations will be accepted in eCTD format for the centralized procedure. One of the best ROIs on eCTD for FDA is the "IND becoming the NDA". What is the EMEA's longterm plan for clinical trial applications (Eudract)?

eCTD / RPS Discussion Forum

Orphan leafs

bootht — Tue, 09 Sep 2008 20:36:38 -0400

When a leaf is submitted, then appended and then replaced... what do you do with the "append?" does it stay out there or do you use the "delete" operator?

eCTD / RPS Discussion Forum

Participation

bootht — Tue, 09 Sep 2008 20:24:27 -0400

The RPS 2 team is now collecting requirements for the next release - anyone with a liasion background thinking of getting involved?

eCTD / RPS Discussion Forum

RPS Release 2 Kick-Off Meeting

admin — Thu, 31 Jul 2008 10:56:06 -0400

On Thursday, July 24, 2008, FDA hosted and co-sponsored, along with PhRMA, the Regulated Product Submission (RPS) Release 2 Kick-off Meeting. Held at the White Oak campus, the all day meeting was attended by 62 participants (either in person or remotely) representing Industry (29), Health Authorities (18) and Vendors/Consultants (15).

eCTD / RPS Discussion Forum

When do you need an eCTD waiver from CDER?

Fri, 30 May 2008 17:52:48 -0400

Since January 1 2008, eCTD has been the only acceptable electronic submission format for CDER -- unless you get a waiver.

So when do you need a waiver, and how do you get one?

A waiver is needed for an NDA, ANDA, BLA application, supplement, or annual report that is to be submitted electronically in a format other than eCTD.

The URL below links to a presentation by Ginny Ventura from the Office of Business Process Support at CDER that explains the waiver process.

eCTD / RPS Discussion Forum

Preassigned application numbers

nsmerkanich — Tue, 20 May 2008 14:34:16 -0400

The FDA wants companies to use secure email to obtain application numbers.
Here is the link to the latest guidance info:
http://www.fda.gov/cder/regulatory/ersr ... cation.htm

eCTD / RPS Discussion Forum

FDA Form 3674/clintrial.gov

nsmerkanich — Tue, 20 May 2008 14:33:55 -0400

FDA told us to put as a separate leaf with the cover letter in M1.2 for those submissions that require it. This is not in the eCTD spec nor will it be any time soon!
For more info on how to use the form check out:
http://www.fda.gov/oc/initiatives/fdaaa ... tions.html

eCTD / RPS Discussion Forum

eCTD and Smart Forms

nsmerkanich — Tue, 20 May 2008 14:23:38 -0400

Check out this presentation, as well as the Forms page at FDA:
http://www.fda.gov/cder/regulatory/ersr ... dation.pdf
http://www.fda.gov/opacom/morechoices/f ... forms.html

eCTD / RPS Discussion Forum

Case Report Forms in eCTD

swaring — Fri, 16 May 2008 13:02:47 -0400

Latest guidance states that eCRF should be a scanned image of paper CRF including all original entries with all modifications, addenda, corrections, comments, annotations and any extemporaneous additions.

Traditionally, we have submitted the original CRF page as it comes in, and any DCFs for that page, which are linked to the original page. Is this still acceptable, or does FDA want the "working copy" of the CRF page, that has the original entry as well as the handwritten corrections on it, along with the DCF?

eCTD / RPS Discussion Forum

FDA eCTD Validation Criteria

pthomas — Wed, 02 Apr 2008 10:22:40 -0400

FDA has recently posted their Specification for eCTD Validation Criteria (http://www.fda.gov/cder/regulatory/ersr/validation_specs.htm

I found some of the severity-classification of some of the validation checks interesting - for example, invalid checksums in an eCTD (check #1374) is weighted as 'low'...

eCTD / RPS Discussion Forum

Tagged PDFs

lalleyne — Wed, 02 Jan 2008 18:11:57 -0500

The FDA's PDF guidance requests that all PDFs are tagged. I have had occasions when either I have received PDFs that are not tagged or had problems rendering files and have had to remove the tagging. How important is it to FDA that PDF files are tagged?