Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

A clinical monitor can be an employee of the company and even part of the clinical team.  There is no requirement/expectation that they be independent of the clinical team.  This is different than an auditor, who should be independent of the clinical group. The qualifications for a monitor are generally described in numerous guidances (such as ISO 145155 and ICH) but this person can be anyone who is qualified.  It does not matter if the work in regulatory as long as they are properly trained and qualified to be a monitor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

I don't think a clinical monitor is different from an auditor.  I think you just need to figure out on whose behalf they are auditing the quality and completeness of the data, and who is responsible for collecting those data.  Usually the study is monitored on behalf of the sponsor (because it's the sponsor that needs quality and complete data) and the clinical investigator is responsible for collecting the data.  As the sponsor, I would want the monitor to be independent of the clinical investigator, because I would see that as a conflict of interest.  Who pulled together the clinical documents is irrelevant, unless the monitor is also auditing the quality of those documents.  On the contrary, the more the monitor knows about the study, including the documents, the better the job they can do at monitoring it.

I think the qualification that are needed to monitor data quality is an understanding of clinical data (can you read a patient chart, figure out if an adverse event was severe) and in the general concept of "evidence," since the monitor needs to confirm that there is evidence (eg, lab report) to support the data that the clinical investigator is reporting.  I would want my study monitored for data quality, regulatory compliance, and subject safety.  A lot of sponsors also want study progress to be closely monitored.

I think subject safety should be monitored by a clinical professional.  This does not mean that they have to make site visits, but that they should review the data to assure that no safety issues have emerged during the course of the study.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Jul-2019 07:28
From: Michael Hamrell
Subject: Clinical investigation data monitors

A clinical monitor can be an employee of the company and even part of the clinical team.  There is no requirement/expectation that they be independent of the clinical team.  This is different than an auditor, who should be independent of the clinical group. The qualifications for a monitor are generally described in numerous guidances (such as ISO 145155 and ICH) but this person can be anyone who is qualified.  It does not matter if the work in regulatory as long as they are properly trained and qualified to be a monitor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Actually, monitoring and auditing are two completely different things and roles in GCP.  Monitoring is the ongoing QC oversight of a clinical study to check on data integrity, study execution and ethical oversight,  Auditing on the other hand, is a QA function performed at various points to verify study execution and data integrity.  It is really no different than the role of QC and QA in GMP (or GLP).

Monitors typically work for the company that is sponsor of the study, thought these days this is often subcontracted to a CRO (who works for the sponsor).  QA is performed by a separate QA function (or subcontractor) who reports independently to management.  Monitoring of a study does involve actual site visits in order to verify collected information against the subject medical records.  This is a cornerstone of clinical monitoring.

Safety monitoring is a different function that is handled by professionals in the safety oversight dept (pharmacovigilance).  These persons do need specific expertise in the review and interpretation of safety information.

It is expected that all personnel involved in the management and oversight of a clinical study must be adequately trained in clinical research and GCP.  Therapeutic experience can also be very helpful.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 08-Jul-2019 19:22
From: Julie Omohundro
Subject: Clinical investigation data monitors

I don't think a clinical monitor is different from an auditor.  I think you just need to figure out on whose behalf they are auditing the quality and completeness of the data, and who is responsible for collecting those data.  Usually the study is monitored on behalf of the sponsor (because it's the sponsor that needs quality and complete data) and the clinical investigator is responsible for collecting the data.  As the sponsor, I would want the monitor to be independent of the clinical investigator, because I would see that as a conflict of interest.  Who pulled together the clinical documents is irrelevant, unless the monitor is also auditing the quality of those documents.  On the contrary, the more the monitor knows about the study, including the documents, the better the job they can do at monitoring it.

I think the qualification that are needed to monitor data quality is an understanding of clinical data (can you read a patient chart, figure out if an adverse event was severe) and in the general concept of "evidence," since the monitor needs to confirm that there is evidence (eg, lab report) to support the data that the clinical investigator is reporting.  I would want my study monitored for data quality, regulatory compliance, and subject safety.  A lot of sponsors also want study progress to be closely monitored.

I think subject safety should be monitored by a clinical professional.  This does not mean that they have to make site visits, but that they should review the data to assure that no safety issues have emerged during the course of the study.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 08-Jul-2019 07:28
From: Michael Hamrell
Subject: Clinical investigation data monitors

A clinical monitor can be an employee of the company and even part of the clinical team.  There is no requirement/expectation that they be independent of the clinical team.  This is different than an auditor, who should be independent of the clinical group. The qualifications for a monitor are generally described in numerous guidances (such as ISO 145155 and ICH) but this person can be anyone who is qualified.  It does not matter if the work in regulatory as long as they are properly trained and qualified to be a monitor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Michael, in my lexicon, QC is done by those who produce the product (e.g., clinical data).  That would be the clinical investigator, not the study sponsor. 

QA is done to assure management (eg., a study sponsor) that the product being produced meets quality requirements. It is up to management to decide what it needs to feel assured, including  who will conduct QA on its behalf, and what type of QA activities will be conducted. If management feels the need to have someone check on data quality on an ongoing basis and to also have someone else verify data quality at various points in the study, then that's its prerogative.  If it feels the need for only one or the other, or neither, then that is its perogative as well.  

Another common view is that QC is product-focused, while QA is process-focused.  This would dictate that all activities intended to evaluate the quality of data for a specific study (manufacturing lot) are QC, and that all activities intended to determine whether the process being used will reliably produce acceptable quality across studies (manufacturing lots) are QA.  From this perspective, both monitoring and auditing of the data for a specific study are QC.  I think this viewpoint is adopted more for pragmatic purposes, rather than as a quality philosophy, because it is often the only way to persuade management, which likes to think it has both QC and QA, to support activities that evaluate processes in addition to product.

Certainly various regulations and standards will specify the who and the what and the how often.  For studies to be conducted in compliance with specified regulations and/or in conformance to specified standards, management's authority to decide these things is curtailed.  Regardless, monitoring and auditing both remain forms of QA, IMO. 

The term "monitoring" was coined within the pharma space way back, I don't know by whom, but not by quality professionals.  Pharma, which at the time managed and monitored its own clinical trials, had no clinical research quality anything in place at the time, and CROs were virtually non-existent.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 08-Jul-2019 20:02
From: Michael Hamrell
Subject: Clinical investigation data monitors

Actually, monitoring and auditing are two completely different things and roles in GCP.  Monitoring is the ongoing QC oversight of a clinical study to check on data integrity, study execution and ethical oversight,  Auditing on the other hand, is a QA function performed at various points to verify study execution and data integrity.  It is really no different than the role of QC and QA in GMP (or GLP).

Monitors typically work for the company that is sponsor of the study, thought these days this is often subcontracted to a CRO (who works for the sponsor).  QA is performed by a separate QA function (or subcontractor) who reports independently to management.  Monitoring of a study does involve actual site visits in order to verify collected information against the subject medical records.  This is a cornerstone of clinical monitoring.

Safety monitoring is a different function that is handled by professionals in the safety oversight dept (pharmacovigilance).  These persons do need specific expertise in the review and interpretation of safety information.

It is expected that all personnel involved in the management and oversight of a clinical study must be adequately trained in clinical research and GCP.  Therapeutic experience can also be very helpful.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 08-Jul-2019 19:22
From: Julie Omohundro
Subject: Clinical investigation data monitors

I don't think a clinical monitor is different from an auditor.  I think you just need to figure out on whose behalf they are auditing the quality and completeness of the data, and who is responsible for collecting those data.  Usually the study is monitored on behalf of the sponsor (because it's the sponsor that needs quality and complete data) and the clinical investigator is responsible for collecting the data.  As the sponsor, I would want the monitor to be independent of the clinical investigator, because I would see that as a conflict of interest.  Who pulled together the clinical documents is irrelevant, unless the monitor is also auditing the quality of those documents.  On the contrary, the more the monitor knows about the study, including the documents, the better the job they can do at monitoring it.

I think the qualification that are needed to monitor data quality is an understanding of clinical data (can you read a patient chart, figure out if an adverse event was severe) and in the general concept of "evidence," since the monitor needs to confirm that there is evidence (eg, lab report) to support the data that the clinical investigator is reporting.  I would want my study monitored for data quality, regulatory compliance, and subject safety.  A lot of sponsors also want study progress to be closely monitored.

I think subject safety should be monitored by a clinical professional.  This does not mean that they have to make site visits, but that they should review the data to assure that no safety issues have emerged during the course of the study.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 08-Jul-2019 07:28
From: Michael Hamrell
Subject: Clinical investigation data monitors

A clinical monitor can be an employee of the company and even part of the clinical team.  There is no requirement/expectation that they be independent of the clinical team.  This is different than an auditor, who should be independent of the clinical group. The qualifications for a monitor are generally described in numerous guidances (such as ISO 145155 and ICH) but this person can be anyone who is qualified.  It does not matter if the work in regulatory as long as they are properly trained and qualified to be a monitor.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

It has been convention that monitors be independent as well as auditors of the clinical site and especially the investigator to eliminate bias. The following information from the Code of Federal Regulations part 312 and ICH E6 make it very clear that it is the sponsor's responsibility for the choice of monitors.

312.50 General responsibilities of sponsors.

 

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.

312.53 (d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to monitor the progress of the investigation.

ICH E6 (R2)5.18.2 Selection and Qualifications of Monitors

(a) Monitors should be appointed by the sponsor.

(b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor's qualifications should be documented.

(c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor's SOPs, GCP, and the applicable regulatory requirement(s).

Clinical investigators are usually found in hospitals, private practice, and other medical settings. It is very unlikely that monitors could be obtained that could be found independently in the organization. Remember again that the sponsor has to approve.

Auditors of clinical studies for conformance to GCP are for the most part independent of the organization being audited. Although at times it appears that auditors and monitors are performing the same function, the auditor can delve deeply into such things as root causes of deviation, personnel training, manpower allocation, etc. Auditors will also ask questions of all staff, monitors generally do not. For example sponsors like to choose rather prominent individuals for principal investigators. One question I as an auditor routinely ask if the PI is PI and sub PI on many studies how does the PI have time or what methods are used to fulfill the PI's requirements under part 312 of the code. Obviously I don't put it so directly but the same information is obtained. Monitors normally do not get into this.

------------------------------
Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
1120 Bloomfield Ave., Suite 103
West Caldwell, NJ 07006
rschiff13@aol.com
973-568-3361
------------------------------

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Greetings,
Having direct experience in clinical (both on sponsor and clinical side), I can assure you that in-house personnel can function as the clinical monitor so long as they are properly trained. I would strongly encourage whomever would be designated to visit ACRP's website for relevant content as well as begin the hunt for training material (webinars, forums, etc.). Monitoring is intense and there is a lot more to it than what is outlined in guidance documents or ICH E6 - its a career, not a responsibility. I am not sure where you are based, but if you are in the US running a US trial, I would also suggest becoming familiar with FDA's Bioresearch Monitoring (BIMO) compliance program guidance manual for Sponsors, Contract Research Organizations and Monitors - this will help to understand what is to be expected in the event of an inspection on your trial.
Ideally, you should have someone who has been properly trained with extensive experience in monitoring to train other upcoming monitors - a clinical affairs-specific consultant may help with this (not a regulatory-specific consultant). I have to emphasize: Experience - Experience - Experience. Every great monitor has some great stories of lessons learned. It is amazing what clinical sites can, will or have done that only a good monitor knows how to manage. I don't want to discourage you, but someone who knows the clinical documentation and expectation from a regulatory lens really does not know what it takes to be a monitor unless properly trained. 
If you have a QMS program, I would check with your vendor on any template SOPs to give you a preliminary sense of what is expected (from the sponsor side). If your QMS vendor does not have SOPs available for you, then definitely seek out a consultant in Clinical Monitoring to get your feet off the ground. 
Happy to connect on LinkedIn if you want to ask more questions.
Good luck,
Danni

------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States
------------------------------

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Danielle, there is a wide distance between "can" and "should."  Under no circumstances would I advise a client to let clinical sites "monitor" the quality of their own work.  Moreover, if a CRO is involved, I'm a big fan of periodic risk-based third-party audits, as these serve as a check on the quality of work being done by both the sites and the CRO.

BIMO is a good source for many different kinds of information related to clinical trials, but BIMO isn't going to lose money or get sued if things go south.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Jul-2019 10:21
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Greetings,
Having direct experience in clinical (both on sponsor and clinical side), I can assure you that in-house personnel can function as the clinical monitor so long as they are properly trained. I would strongly encourage whomever would be designated to visit ACRP's website for relevant content as well as begin the hunt for training material (webinars, forums, etc.). Monitoring is intense and there is a lot more to it than what is outlined in guidance documents or ICH E6 - its a career, not a responsibility. I am not sure where you are based, but if you are in the US running a US trial, I would also suggest becoming familiar with FDA's Bioresearch Monitoring (BIMO) compliance program guidance manual for Sponsors, Contract Research Organizations and Monitors - this will help to understand what is to be expected in the event of an inspection on your trial.
Ideally, you should have someone who has been properly trained with extensive experience in monitoring to train other upcoming monitors - a clinical affairs-specific consultant may help with this (not a regulatory-specific consultant). I have to emphasize: Experience - Experience - Experience. Every great monitor has some great stories of lessons learned. It is amazing what clinical sites can, will or have done that only a good monitor knows how to manage. I don't want to discourage you, but someone who knows the clinical documentation and expectation from a regulatory lens really does not know what it takes to be a monitor unless properly trained.
If you have a QMS program, I would check with your vendor on any template SOPs to give you a preliminary sense of what is expected (from the sponsor side). If your QMS vendor does not have SOPs available for you, then definitely seek out a consultant in Clinical Monitoring to get your feet off the ground.
Happy to connect on LinkedIn if you want to ask more questions.
Good luck,
Danni

------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Julie,
It is pretty clear the request is in regard to the Sponsor having their own monitor. I have made no indication that the site is to provision a monitor nor was that ever asked. My response is purely from the Sponsor perspective. Please respect the information provided in light of my qualifications.
-Danni


------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States
------------------------------

Original Message:
Sent: 09-Jul-2019 12:24
From: Julie Omohundro
Subject: Clinical investigation data monitors

Danielle, there is a wide distance between "can" and "should."  Under no circumstances would I advise a client to let clinical sites "monitor" the quality of their own work.  Moreover, if a CRO is involved, I'm a big fan of periodic risk-based third-party audits, as these serve as a check on the quality of work being done by both the sites and the CRO.

BIMO is a good source for many different kinds of information related to clinical trials, but BIMO isn't going to lose money or get sued if things go south.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 09-Jul-2019 10:21
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Greetings,
Having direct experience in clinical (both on sponsor and clinical side), I can assure you that in-house personnel can function as the clinical monitor so long as they are properly trained. I would strongly encourage whomever would be designated to visit ACRP's website for relevant content as well as begin the hunt for training material (webinars, forums, etc.). Monitoring is intense and there is a lot more to it than what is outlined in guidance documents or ICH E6 - its a career, not a responsibility. I am not sure where you are based, but if you are in the US running a US trial, I would also suggest becoming familiar with FDA's Bioresearch Monitoring (BIMO) compliance program guidance manual for Sponsors, Contract Research Organizations and Monitors - this will help to understand what is to be expected in the event of an inspection on your trial.
Ideally, you should have someone who has been properly trained with extensive experience in monitoring to train other upcoming monitors - a clinical affairs-specific consultant may help with this (not a regulatory-specific consultant). I have to emphasize: Experience - Experience - Experience. Every great monitor has some great stories of lessons learned. It is amazing what clinical sites can, will or have done that only a good monitor knows how to manage. I don't want to discourage you, but someone who knows the clinical documentation and expectation from a regulatory lens really does not know what it takes to be a monitor unless properly trained.
If you have a QMS program, I would check with your vendor on any template SOPs to give you a preliminary sense of what is expected (from the sponsor side). If your QMS vendor does not have SOPs available for you, then definitely seek out a consultant in Clinical Monitoring to get your feet off the ground.
Happy to connect on LinkedIn if you want to ask more questions.
Good luck,
Danni

------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

I agree with Julie. 

------------------------------
Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
1120 Bloomfield Ave., Suite 103
West Caldwell, NJ 07006
rschiff13@aol.com
973-568-3361
------------------------------

Original Message:
Sent: 09-Jul-2019 12:35
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Julie,
It is pretty clear the request is in regard to the Sponsor having their own monitor. I have made no indication that the site is to provision a monitor nor was that ever asked. My response is purely from the Sponsor perspective. Please respect the information provided in light of my qualifications.
-Danni


------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 09-Jul-2019 12:24
From: Julie Omohundro
Subject: Clinical investigation data monitors

Danielle, there is a wide distance between "can" and "should."  Under no circumstances would I advise a client to let clinical sites "monitor" the quality of their own work.  Moreover, if a CRO is involved, I'm a big fan of periodic risk-based third-party audits, as these serve as a check on the quality of work being done by both the sites and the CRO.

BIMO is a good source for many different kinds of information related to clinical trials, but BIMO isn't going to lose money or get sued if things go south.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 09-Jul-2019 10:21
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Greetings,
Having direct experience in clinical (both on sponsor and clinical side), I can assure you that in-house personnel can function as the clinical monitor so long as they are properly trained. I would strongly encourage whomever would be designated to visit ACRP's website for relevant content as well as begin the hunt for training material (webinars, forums, etc.). Monitoring is intense and there is a lot more to it than what is outlined in guidance documents or ICH E6 - its a career, not a responsibility. I am not sure where you are based, but if you are in the US running a US trial, I would also suggest becoming familiar with FDA's Bioresearch Monitoring (BIMO) compliance program guidance manual for Sponsors, Contract Research Organizations and Monitors - this will help to understand what is to be expected in the event of an inspection on your trial.
Ideally, you should have someone who has been properly trained with extensive experience in monitoring to train other upcoming monitors - a clinical affairs-specific consultant may help with this (not a regulatory-specific consultant). I have to emphasize: Experience - Experience - Experience. Every great monitor has some great stories of lessons learned. It is amazing what clinical sites can, will or have done that only a good monitor knows how to manage. I don't want to discourage you, but someone who knows the clinical documentation and expectation from a regulatory lens really does not know what it takes to be a monitor unless properly trained.
If you have a QMS program, I would check with your vendor on any template SOPs to give you a preliminary sense of what is expected (from the sponsor side). If your QMS vendor does not have SOPs available for you, then definitely seek out a consultant in Clinical Monitoring to get your feet off the ground.
Happy to connect on LinkedIn if you want to ask more questions.
Good luck,
Danni

------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.

Danielle, I thought there was ambiguity, but maybe that's just me.

The original post referred to someone "representing" the sponsor and then spoke of the sponsor in the third person.  ("The sponsor is a small company...")  Since monitors always represent the sponsor, regardless of their affiliation, that added some confusion for me.

If in referring to "in-house personnel" you meant the Sponsor's house, then I concur, there is no reason the monitor cannot be an employee of the Sponsor.  More than that, I consider this to be the ideal situation, assuming someone in the house is fully qualified to monitor.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 09-Jul-2019 12:35
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Julie,
It is pretty clear the request is in regard to the Sponsor having their own monitor. I have made no indication that the site is to provision a monitor nor was that ever asked. My response is purely from the Sponsor perspective. Please respect the information provided in light of my qualifications.
-Danni


------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 09-Jul-2019 12:24
From: Julie Omohundro
Subject: Clinical investigation data monitors

Danielle, there is a wide distance between "can" and "should."  Under no circumstances would I advise a client to let clinical sites "monitor" the quality of their own work.  Moreover, if a CRO is involved, I'm a big fan of periodic risk-based third-party audits, as these serve as a check on the quality of work being done by both the sites and the CRO.

BIMO is a good source for many different kinds of information related to clinical trials, but BIMO isn't going to lose money or get sued if things go south.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 09-Jul-2019 10:21
From: Danielle Briggeman
Subject: Clinical investigation data monitors

Greetings,
Having direct experience in clinical (both on sponsor and clinical side), I can assure you that in-house personnel can function as the clinical monitor so long as they are properly trained. I would strongly encourage whomever would be designated to visit ACRP's website for relevant content as well as begin the hunt for training material (webinars, forums, etc.). Monitoring is intense and there is a lot more to it than what is outlined in guidance documents or ICH E6 - its a career, not a responsibility. I am not sure where you are based, but if you are in the US running a US trial, I would also suggest becoming familiar with FDA's Bioresearch Monitoring (BIMO) compliance program guidance manual for Sponsors, Contract Research Organizations and Monitors - this will help to understand what is to be expected in the event of an inspection on your trial.
Ideally, you should have someone who has been properly trained with extensive experience in monitoring to train other upcoming monitors - a clinical affairs-specific consultant may help with this (not a regulatory-specific consultant). I have to emphasize: Experience - Experience - Experience. Every great monitor has some great stories of lessons learned. It is amazing what clinical sites can, will or have done that only a good monitor knows how to manage. I don't want to discourage you, but someone who knows the clinical documentation and expectation from a regulatory lens really does not know what it takes to be a monitor unless properly trained.
If you have a QMS program, I would check with your vendor on any template SOPs to give you a preliminary sense of what is expected (from the sponsor side). If your QMS vendor does not have SOPs available for you, then definitely seek out a consultant in Clinical Monitoring to get your feet off the ground.
Happy to connect on LinkedIn if you want to ask more questions.
Good luck,
Danni

------------------------------
Danielle Briggeman MS
Clinical & Regulatory Affairs Manager
Portland ME
United States

Original Message:
Sent: 04-Jul-2019 09:38
From: Anonymous Member
Subject: Clinical investigation data monitors

This message was posted by a user wishing to remain anonymous

Hi everyone,

What is the training and experience study data monitors?  Note, the study monitor is somebody who oversees the quality and completeness of the data, not to be confused with the data safety monitoring committee.  I have searched ISO 14155 and also did some research online.  It looks like somebody with CRA credentials can do it.  But I also wonder if somebody representing the sponsor can do it too, e.g. an experienced regulatory affairs specialist with some training in clinical research.  Does it matter that the person representing the sponsor was also heavily involved in putting together the clinical documents?  The sponsor is a small company where almost everyone is involved in putting together the clinical documents.

Thanks.