Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

I would submit it as an information amendment. I think it will be more likely to get routed to the correct place faster that way.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

Sent from my iPad


Original Message:
Sent: 2/18/2022 8:19:00 AM
From: Glen Park
Subject: RE: DSMB charter submission to IND

I would submit it as an information amendment. I think it will be more likely to get routed to the correct place faster that way.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

Hello, if FDA advised your company to submit a DSMB charter for a phase 1 study in patients with late stage disease, you might think about sending a communication to your FDA project mgr and ask them for guidance on whether the FDA team would like this DSMB submitted to the IND as an Information clinical/safety amendment or as an Other amendment. This approach will help by letting the FDA team that your company has followed through on the advice and will further establish a line of communication with the project mgr for any future questions.

Deborah Tady, PharmD, RPh, MBA, RAC
Mission KS
Sent from my iPad


Original Message:
Sent: 2/18/2022 8:19:00 AM
From: Glen Park
Subject: RE: DSMB charter submission to IND

I would submit it as an information amendment. I think it will be more likely to get routed to the correct place faster that way.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

This message was posted by a user wishing to remain anonymous

In what section of eCTD does a charter belong?
Original Message:
Sent: 18-Feb-2022 08:18
From: Glen Park
Subject: DSMB charter submission to IND

I would submit it as an information amendment. I think it will be more likely to get routed to the correct place faster that way.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

We submitted in section 5.3.5.1 for our Phase 2b study.

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 14-Mar-2022 16:35
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

In what section of eCTD does a charter belong?
Original Message:
Sent: 18-Feb-2022 08:18
From: Glen Park
Subject: DSMB charter submission to IND

I would submit it as an information amendment. I think it will be more likely to get routed to the correct place faster that way.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

This message was posted by a user wishing to remain anonymous

Based on your drug profile, did someone (or the FDA) advised that you need DSMB for phase 1 especially for patient late stage disease?? As you know DSMB is needed on a case by case basis not for every phase 1 study!
Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

This message was posted by a user wishing to remain anonymous

Its unusual that you are submitting DSMB for a phase 1 trial unless your product is very unique like gene therapy or if the FDA has requested it during your pre-IND meeting?

Please check the guidance for DSMB.
Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.

I would submit as an information request amendment to the original IND submission and  provide the purpose of the submission in the cover letter to the RPM.

------------------------------
Sharon Spratt
Chief, Regulatory Affairs
Vacaville CA
United States
------------------------------

Original Message:
Sent: 17-Feb-2022 15:32
From: Anonymous Member
Subject: DSMB charter submission to IND

This message was posted by a user wishing to remain anonymous

I need to submit a data safety monitoring board (DSMB) charter to an active IND.  It describes how adverse events will be assessed in a phase 1 study involving patients with late-stage disease.  The clinical protocol has already been submitted but did not provide details regarding the DSMB and its specific responsibilities for this study.

Should the DSMB charter be referred to as an "Information Amendment (Clinical/Safety)" or as "Other (Specify)" in Item #11 of Form FDA 1571?

​Thank you for your guidance.