Regulatory Open Forum

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Mona
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Mona:

Under 21 CFR 312.120, the sponsor can add a foreign site (not under the IND). When submitting the info, the sponsor should identify in the cover letter (CL), stating that the info is being submitted under 21 CFR 312.120. 21 CFR 312.120(b) provides the requirements for the submission.  

Please also review the provisions under 21 CFR 312.32(b) [safety review requirements from any source] and 21 CFR 312.32(c) [notification required to both the FDA and all CIs].

Both FDA and all participating CIs under the IND must be informed of adverse events (even if it occurred OUS not under the IND).

Assuming arguendo, even if it is not required, it should be part of GCPs (e.g., notification to the FDA and all CIs).

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Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US
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Original Message:
Sent: 02-Jun-2018 10:39
From: Mona Abdel
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Hello: 

21CFR 312.120 discusses this but there's no mention regarding FDA notification (when sponsor decides to add a foreign site, and reporting of AE/SAE to the Agency), US IRB and other US Investigator sites' notification (when SAEs occur) assuming this foreign site was not included in the IND. 

Please advise if this is mentioned elsewhere.

Thanks!

Mona

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Mona
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Hello David:
Thank you. Just to clarify:

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Mona
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Original Message:
Sent: 02-Jun-2018 13:35
From: David Lim
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Mona:

Under 21 CFR 312.120, the sponsor can add a foreign site (not under the IND). When submitting the info, the sponsor should identify in the cover letter (CL), stating that the info is being submitted under 21 CFR 312.120. 21 CFR 312.120(b) provides the requirements for the submission.

Please also review the provisions under 21 CFR 312.32(b) [safety review requirements from any source] and 21 CFR 312.32(c) [notification required to both the FDA and all CIs].

Both FDA and all participating CIs under the IND must be informed of adverse events (even if it occurred OUS not under the IND).

Assuming arguendo, even if it is not required, it should be part of GCPs (e.g., notification to the FDA and all CIs).

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US

Original Message:
Sent: 02-Jun-2018 10:39
From: Mona Abdel
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Hello: 

21CFR 312.120 discusses this but there's no mention regarding FDA notification (when sponsor decides to add a foreign site, and reporting of AE/SAE to the Agency), US IRB and other US Investigator sites' notification (when SAEs occur) assuming this foreign site was not included in the IND. 

Please advise if this is mentioned elsewhere.

Thanks!

Mona

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Mona
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Still required to report/document safety issues regardless where the site is for a clinical protocol.

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GRSAOnline
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Original Message:
Sent: 03-Jun-2018 02:12
From: Mona Abdel
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Hello David:
Thank you. Just to clarify:

The sponsor is adding a foreign site which will not be under IND. They are amending the protocol exclusively for the foreign site (and adding a new investigator for the foreign site). FDA notification is still required to comply with 21 CFR 312.30, correct? I would like to confirm that this requirement is not waived for the foreign site that's not under IND. 

Thanks a lot!
Mona

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Mona

Original Message:
Sent: 02-Jun-2018 13:35
From: David Lim
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Mona:

Under 21 CFR 312.120, the sponsor can add a foreign site (not under the IND). When submitting the info, the sponsor should identify in the cover letter (CL), stating that the info is being submitted under 21 CFR 312.120. 21 CFR 312.120(b) provides the requirements for the submission.

Please also review the provisions under 21 CFR 312.32(b) [safety review requirements from any source] and 21 CFR 312.32(c) [notification required to both the FDA and all CIs].

Both FDA and all participating CIs under the IND must be informed of adverse events (even if it occurred OUS not under the IND).

Assuming arguendo, even if it is not required, it should be part of GCPs (e.g., notification to the FDA and all CIs).

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US

Original Message:
Sent: 02-Jun-2018 10:39
From: Mona Abdel
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Hello: 

21CFR 312.120 discusses this but there's no mention regarding FDA notification (when sponsor decides to add a foreign site, and reporting of AE/SAE to the Agency), US IRB and other US Investigator sites' notification (when SAEs occur) assuming this foreign site was not included in the IND. 

Please advise if this is mentioned elsewhere.

Thanks!

Mona

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Mona
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I presume you have seen these two <g class="gr_ gr_94 gr-alert gr_spell gr_inline_cards gr_disable_anim_appear ContextualSpelling ins-del" id="94" data-gr-id="94">guidances</g>. If not, they are quite specific about what is needed for foreign entities

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.PDF



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[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]
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Original Message:
Sent: 02-Jun-2018 10:39
From: Mona Abdel
Subject: Multinational study including US site (under IND) and foreign site (not under IND)

Hello: 

21CFR 312.120 discusses this but there's no mention regarding FDA notification (when sponsor decides to add a foreign site, and reporting of AE/SAE to the Agency), US IRB and other US Investigator sites' notification (when SAEs occur) assuming this foreign site was not included in the IND. 

Please advise if this is mentioned elsewhere.

Thanks!

Mona

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Mona
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