Regulatory Open Forum

Dear,

As my first post on the RAPS forum, I have a question relating to Module 5 for an initial eIND my company is planning to submit.

Module 5 should contain the clinical study reports that are referenced in the eIND. Depending on source however, it is not clear to me whether the clinical study reports can be a single pdf each (provided all ICH-requested items are present), or need to be split into separate subsections (e.g., according to the granularity suggested in the Guidance for Industry for Regulatory Submissions in Electronic Format, p.18).

Since the available clinical study reports are quite comprehensive (and extensive), and are already organised according to ICH requirements (incl. copies of protocol etc. in appendix), not having to split them (and reworking hyperlinks etc.) would a major benefit; they would be uploaded in the eIND backbone as single pdf's in the appropriate location(s).

Many thanks in advance for your help!

Tim

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Tim De Smedt
Regulatory Affairs Manager
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Hi Tim,

I recently experienced this same opportunity. I had two study reports to submit, one followed the suggested granular format and the other legacy. I submitted both, one in legacy and one granular.  The key was that all hyperlinks, etc were still usable even in the legacy document. 

Hope this is helpful,

Dar

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Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 08-07-2014 11:42
From: Tim De Smedt
Subject: IND Module 5

Dear,

As my first post on the RAPS forum, I have a question relating to Module 5 for an initial eIND my company is planning to submit.

Module 5 should contain the clinical study reports that are referenced in the eIND. Depending on source however, it is not clear to me whether the clinical study reports can be a single pdf each (provided all ICH-requested items are present), or need to be split into separate subsections (e.g., according to the granularity suggested in the Guidance for Industry for Regulatory Submissions in Electronic Format, p.18).

Since the available clinical study reports are quite comprehensive (and extensive), and are already organised according to ICH requirements (incl. copies of protocol etc. in appendix), not having to split them (and reworking hyperlinks etc.) would a major benefit; they would be uploaded in the eIND backbone as single pdf's in the appropriate location(s).

Many thanks in advance for your help!

Tim

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Tim De Smedt
Regulatory Affairs Manager
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