Regulatory Open Forum

Hello,

Instead of sending Safety Reports (SUSARS, etc.) via eCTD submissions (and using publishing software), can they be sent via Webtrader? What are the advantages/disadvantages of this approach?

Thanks,

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Hi Saurabh,

FDA offers two options for electronic submission of safety reports to FAERS:
(1) Database-to-Database Transmission (ESG) and
While using this method safety reports must be submitted in XML format (eCTD format/requires publishing tool)
(2) submission through the Safety Reporting Portal (SRP).
Applicants and non-applicants who do not have database-to-database capability may submit electronic safety reports using the SRP.
Note:Those who can access ESG account cannot use the SRP system. 
If your company does not set up for database-to-database (E2B) transmissions, then you can request for SRP account to FDA . (but in SRP you need to enter all safety related information manually into a Web-based form)

------------------------------
Amit Jain
United States
------------------------------

Original Message:
Sent: 29-Mar-2018 10:36
From: Saurabh Kothari
Subject: FDA safety report submissions

Hello,

Instead of sending Safety Reports (SUSARS, etc.) via eCTD submissions (and using publishing software), can they be sent via Webtrader? What are the advantages/disadvantages of this approach?

Thanks,

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Hi Amit,

Thank you for your response. This is really helpful!

Regards,
Saurabh

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Original Message:
Sent: 29-Mar-2018 14:46
From: Amit Jain
Subject: FDA safety report submissions

Hi Saurabh,

FDA offers two options for electronic submission of safety reports to FAERS:
(1) Database-to-Database Transmission (ESG) and
While using this method safety reports must be submitted in XML format (eCTD format/requires publishing tool)
(2) submission through the Safety Reporting Portal (SRP).
Applicants and non-applicants who do not have database-to-database capability may submit electronic safety reports using the SRP.
Note:Those who can access ESG account cannot use the SRP system. 
If your company does not set up for database-to-database (E2B) transmissions, then you can request for SRP account to FDA . (but in SRP you need to enter all safety related information manually into a Web-based form)

------------------------------
Amit Jain
United States

Original Message:
Sent: 29-Mar-2018 10:36
From: Saurabh Kothari
Subject: FDA safety report submissions

Hello,

Instead of sending Safety Reports (SUSARS, etc.) via eCTD submissions (and using publishing software), can they be sent via Webtrader? What are the advantages/disadvantages of this approach?

Thanks,

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------

Original Message:
Sent: 29-Mar-2018 14:46
From: Amit Jain
Subject: FDA safety report submissions

Hi Saurabh,

FDA offers two options for electronic submission of safety reports to FAERS:
(1) Database-to-Database Transmission (ESG) and
While using this method safety reports must be submitted in XML format (eCTD format/requires publishing tool)
(2) submission through the Safety Reporting Portal (SRP).
Applicants and non-applicants who do not have database-to-database capability may submit electronic safety reports using the SRP.
Note:Those who can access ESG account cannot use the SRP system. 
If your company does not set up for database-to-database (E2B) transmissions, then you can request for SRP account to FDA . (but in SRP you need to enter all safety related information manually into a Web-based form)

------------------------------
Amit Jain
United States

Original Message:
Sent: 29-Mar-2018 10:36
From: Saurabh Kothari
Subject: FDA safety report submissions

Hello,

Instead of sending Safety Reports (SUSARS, etc.) via eCTD submissions (and using publishing software), can they be sent via Webtrader? What are the advantages/disadvantages of this approach?

Thanks,

------------------------------
Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
------------------------------