Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

Dear A:

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

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

Since the IND is in effect for over a year, the IND is not new but the protocol is new? I don't think that 30 day waiting period is required for this situation.

So according to the FDA/NIH/MHRA etc... the study start date is defined as " the actual date on which the first participant was enrolled"

That means IRB approval/patient consent is a must prior to the above definition regarding "study start date" to occur/begin.
Hope this helps!

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GRSAOnline
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Original Message:
Sent: 02-Jan-2018 16:53
From: David Lim
Subject: 21 CFR 312.30 - New Protocol

Dear A:

21 CFR 312.30(a) should actually read "..such study may begin.."

It should be interpreted that you (a study sponsor) are allowed to begin a study (recruiting, screening and/or administering a drug(s)). Otherwise, you may want to wait to hear from the FDA. 

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

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

​Also meant to say that protocol must also be submitted to the IND.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 03-Jan-2018 11:27
From: Narayan Rao
Subject: 21 CFR 312.30 - New Protocol

Since the IND is in effect for over a year, the IND is not new but the protocol is new? I don't think that 30 day waiting period is required for this situation.

So according to the FDA/NIH/MHRA etc... the study start date is defined as " the actual date on which the first participant was enrolled"

That means IRB approval/patient consent is a must prior to the above definition regarding "study start date" to occur/begin.
Hope this helps!

------------------------------
GRSAOnline

Original Message:
Sent: 02-Jan-2018 16:53
From: David Lim
Subject: 21 CFR 312.30 - New Protocol

Dear A:

21 CFR 312.30(a) should actually read "..such study may begin.."

It should be interpreted that you (a study sponsor) are allowed to begin a study (recruiting, screening and/or administering a drug(s)). Otherwise, you may want to wait to hear from the FDA. 

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

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

​Hi Anonymous.

I would agree completely with David on this one.  Having been in this situation in the past, we always looked at the recruitment of subjects and screening as a part of the total study protocol.  So until you have submitted to FDA and received approval in writing from your IRB, I would strongly urge against even starting to discuss the recruitment or screening of subjects for this protocol amendment.  Doing so can only cause you further issues down the road.

On a side note, if you chose to initiate the study (including initiation of recruitment or screening) before receiving IRB formal approval it could also open you to perils other than FDA sanctions - it could in theory at least lead to litigation that would at minimum cause your company a black eye in the public domain. 

So generally, your best bet is to finalize your protocol, submit to both FDA and IRB, and wait to do anything further until you at least have clearance from IRB and notification that your submission has been received by FDA.  Otherwise you could have a lot of uncomfortable explaining to do.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

There is no strict regulatory definition of "study may begin."  My definition would be that the study has begun when an investigator has been initiated and investigational product has been shipped to the site even if no active recruitment has occurred.  Once the investigator has product, there would be nothing to prevent the investigator from administering the product to a patient without the sponsor's knowledge.  

Hope that is clear.

Glen

------------------------------
Glen Park
Scynexis, Inc.
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

This message was posted by a user wishing to remain anonymous

Per regulation, there is no required 30 day clock with a new protocol amendment you may start screening/administering after IRB approval and FDA submission. But It is recommended to check with your FDA project manager before preceding to ensure the review team does not have any concerns. It is considered a best practice to wait ~30 days after submission of a new protocol before starting the study.

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

​I agree with the majority of the commentary provided thus far.  Since the regulations specify that an applicant/study sponsor must submit the protocol to FDA and await approval from the IRB, the intent is to allow the study to start without requiring the 30 day wait period as required for a newly submitted IND.  Typically sponsors receive feedback or input from FDA when designing studies for investigational drug and biologics products (primarily due to the high cost of conducting these studies), so the risk of not waiting the so called 30 days in quite low as compared to the past 20 years. Regarding concerns for preventing an Investigator from treating subjects before IRB approval has been received, I would say that if a sponsor has such a concern, they should do a much better job in selecting qualified study sites and ensure that its Investigators have received adequate GCP training.

------------------------------
Michael Trapani
Senior Consultant
Biologics Consulting Group, Inc.
Monroe Township NJ
United States
------------------------------

Original Message:
Sent: 02-Jan-2018 17:24
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Per regulation, there is no required 30 day clock with a new protocol amendment you may start screening/administering after IRB approval and FDA submission. But It is recommended to check with your FDA project manager before preceding to ensure the review team does not have any concerns. It is considered a best practice to wait ~30 days after submission of a new protocol before starting the study.

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

This message was posted by a user wishing to remain anonymous

I agree with the above responses - in my experience we have waited for IRB approval and submission to FDA to begin recruitment/screening as we consider this part of the study itself.

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

I completely agree with all above responses, there is no required 30 day clock with a new protocol amendment you may start screening after IRB approval and FDA submission. But we had waited for 30days just wanted to be on safer side, because it was a crucial change in our study.

------------------------------
Amit Jain
Olivette MO
United States
------------------------------

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

This message was posted by a user wishing to remain anonymous

​Entirely a new protocol Vs. change to an existing protocol - one is a new study, perhaps its fine with 30-day waiting period just to be safe, but waiting for 30 days to a protocol amendment (i.e. change to an existing protocol), especially after IRB approval is just a waste of time!!
Original Message:
Sent: 05-Jan-2018 09:02
From: Amit Jain
Subject: 21 CFR 312.30 - New Protocol

I completely agree with all above responses, there is no required 30 day clock with a new protocol amendment you may start screening after IRB approval and FDA submission. But we had waited for 30days just wanted to be on safer side, because it was a crucial change in our study.

------------------------------
Amit Jain
Olivette MO
United States

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!

Hi Amit, 

I agreed with your input. I have recently submitted new protocol plus ICF. CRO started screening patients soon as the second week after protocol been submitted. 

Thanks,
Prakash

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Prakash Patel
Sr. Manager Global Regulatory Affairs
Roche (TCS)
Cambridge MA
United States
------------------------------

Original Message:
Sent: 05-Jan-2018 09:02
From: Amit Jain
Subject: 21 CFR 312.30 - New Protocol

I completely agree with all above responses, there is no required 30 day clock with a new protocol amendment you may start screening after IRB approval and FDA submission. But we had waited for 30days just wanted to be on safer side, because it was a crucial change in our study.

------------------------------
Amit Jain
Olivette MO
United States

Original Message:
Sent: 02-Jan-2018 14:43
From: Anonymous Member
Subject: 21 CFR 312.30 - New Protocol

This message was posted by a user wishing to remain anonymous

Dear Forum-

We are planning to submit in a new protocol to our IND that has been in effect for over a year.  The regulations state that a new protocol can begin provided two conditions are met: 1) sponsor submitted the protocol to FDA for its review and 2) the protocol has been approved by the IRB.

My question pertains to the definition of "can begin."  Does that mean administer drug or does it mean recruiting and/or screening patients?

Appreciate any insight.

Thanks for your help!