Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

Hello,

The short answer is yes.  Depending upon whether there was a GCP violation determines additional steps and regulatory impact.  I'd also review the vendor contract.

Best,
Gretchen

------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX
------------------------------

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

This message was posted by a user wishing to remain anonymous

Hi Grechen,

Thank you for the response.

To clarify - the lab currently listed on the ICF will be either deleted or replaced by a different vendor. If the tetsing were to happen it will be after 2 years (after study completion). Would the two such scenarios require the updates to be made to 1572 upon study completion. 

Best Regards
Original Message:
Sent: 31-Aug-2021 12:24
From: Gretchen Upton
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

Hello,

The short answer is yes.  Depending upon whether there was a GCP violation determines additional steps and regulatory impact.  I'd also review the vendor contract.

Best,
Gretchen

------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

Gotcha.  In that case, I would notify the sponsor and update clinical documents.  However, if you are also the sponsor, you could update the protocol via an amendment.


------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX
------------------------------

Original Message:
Sent: 01-Sep-2021 09:32
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Hi Grechen,

Thank you for the response.

To clarify - the lab currently listed on the ICF will be either deleted or replaced by a different vendor. If the tetsing were to happen it will be after 2 years (after study completion). Would the two such scenarios require the updates to be made to 1572 upon study completion.

Best Regards
Original Message:
Sent: 31-Aug-2021 12:24
From: Gretchen Upton
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

Hello,

The short answer is yes.  Depending upon whether there was a GCP violation determines additional steps and regulatory impact.  I'd also review the vendor contract.

Best,
Gretchen

------------------------------
Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

By "removal" you mean that the lab just isn't doing the contracted work any more? I'm not sure you would have to re-do all of the 1572s to take that lab off - the list of laboratories, facilities, etc should be comprehensive and broad, so taking a lab off that list would not seem to warrant a new 1572.

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
------------------------------

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

This message was posted by a user wishing to remain anonymous

Hi Beth, 

Thank you for the response, by removal I meant that incase the testing either will not be conducted (since a exploratory measure) or done by a different vendor. Additional info -- the testing most likely will happen at least 2 years later which is after study completion.

Best Regards
Original Message:
Sent: 01-Sep-2021 08:58
From: Beth Weinberg
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

By "removal" you mean that the lab just isn't doing the contracted work any more? I'm not sure you would have to re-do all of the 1572s to take that lab off - the list of laboratories, facilities, etc should be comprehensive and broad, so taking a lab off that list would not seem to warrant a new 1572.

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

Not sure I really understand your question since the potential scenario is after the current study is completed.  

However, if you plan to use a different laboratory to evaluate the samples collected under the clinical protocol that is completed, that is a different scenario.  Is this the question?

Best,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 01-Sep-2021 09:26
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Hi Beth,

Thank you for the response, by removal I meant that incase the testing either will not be conducted (since a exploratory measure) or done by a different vendor. Additional info -- the testing most likely will happen at least 2 years later which is after study completion.

Best Regards
Original Message:
Sent: 01-Sep-2021 08:58
From: Beth Weinberg
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

By "removal" you mean that the lab just isn't doing the contracted work any more? I'm not sure you would have to re-do all of the 1572s to take that lab off - the list of laboratories, facilities, etc should be comprehensive and broad, so taking a lab off that list would not seem to warrant a new 1572.

------------------------------
Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States

Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

This message was posted by a user wishing to remain anonymous

Most importantly, did you file this laboratory conducting an exploratory measure in your IND/CTA? If yes then has an impact. My question is who advised you to list all these details in your IND or the protocol? Generally we don't go into naming all the laboratories doing all kinds of exploratory measures in the IND. You just describe the measure or testing procedure not who conducts this test etc......
Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

Currently, if the laboratory is not listed in the Protocol, only the exploratory measure is listed in protocol; and if the laboratory  is mentioned only in the ICF it will also have to be included in the  CIF/1572? 

A question in response to one of the input provided here -- Would having the lab address in ICF be considered filing to IND as per this statement  "did you file this laboratory conducting an exploratory measure in your IND/CTA"?



Original Message:
Sent: 31-Aug-2021 12:50
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Most importantly, did you file this laboratory conducting an exploratory measure in your IND/CTA? If yes then has an impact. My question is who advised you to list all these details in your IND or the protocol? Generally we don't go into naming all the laboratories doing all kinds of exploratory measures in the IND. You just describe the measure or testing procedure not who conducts this test etc......
Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you

Generally speaking you don't need to specify what labs are conducting the actual testing (I am only talking about clinical and non clinical testing aspects, not an overall study conduct say a nonclinical study by a an organization). I am specifically talking about labs that do testing say for 'inclusion criteria' like ALK positive tumor you don't need to specify the name and address of the labs in the regulatory documents submitted to the FDA, these details should go into Study master file which should be kept on site. Hope this is clear!

Your question: "Currently, if the laboratory is not listed in the Protocol, only the exploratory measure is listed in protocol; and if the laboratory  is mentioned only in the ICF it will also have to be included in the  CIF/1572?" Absolutely NOT necessary.

"A question in response to one of the input provided here -- Would having the lab address in ICF be considered filing to IND as per this statement  "did you file this laboratory conducting an exploratory measure in your IND/CTA"?" 
Absolutely NO. In the future, please don't include the details such as lab address, name etc on the regulatory documents, they should be kept on site in trial Master file or some other internal documents for any onsite potential GCP inspections.

Hope this is helpful



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

Original Message:
Sent: 01-Sep-2021 10:52
From: Dipika Tuteja Shringarpure
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

Currently, if the laboratory is not listed in the Protocol, only the exploratory measure is listed in protocol; and if the laboratory  is mentioned only in the ICF it will also have to be included in the  CIF/1572?

A question in response to one of the input provided here -- Would having the lab address in ICF be considered filing to IND as per this statement  "did you file this laboratory conducting an exploratory measure in your IND/CTA"?



Original Message:
Sent: 31-Aug-2021 12:50
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Most importantly, did you file this laboratory conducting an exploratory measure in your IND/CTA? If yes then has an impact. My question is who advised you to list all these details in your IND or the protocol? Generally we don't go into naming all the laboratories doing all kinds of exploratory measures in the IND. You just describe the measure or testing procedure not who conducts this test etc......
Original Message:
Sent: 30-Aug-2021 18:51
From: Anonymous Member
Subject: Regulatory Impact - Removal of a Lab from 1572/CIF

This message was posted by a user wishing to remain anonymous

Dear Community,

A question on the Regulatory Impact of removal of a laboratory conducting exploratory measure in a Phase 3 clinical trial.

If down the product development, there is removal of such a laboratory from the clinical protocol/ICF, does it warrant updates to the 1572(US)/CIF(ex-US) in the INC/CTA? What is the regulatory impact for such a change?

Thank you