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  4. Surveillance: Post Drug-Approval Activities
  5. FDA's Adverse Event Reporting System (FAERS)
  6. FAQs: Safety Reporting Portal
  1. FDA's Adverse Event Reporting System (FAERS)

FAQs: Safety Reporting Portal

Account Information  

  1. What if my company represents multiple sponsors?

    If your company represents multiple sponsors, then you MUST register for an individual Group Lead account for each sponsor. Each Group Lead account is required to have a separate and distinct email address.

  2. Can I have more than one Group Lead account per sponsor?

    No, you may only have one Group Lead account per sponsor.  

  3. How can a Group Lead manage the SRP Account?

    Please visit the FAQs section on the SRP website for quick tips once an account is established.

  4. What happens if we change our Group Lead?

    Please contact the FAERSesub@fda.hhs.gov to change the Group Lead contact information.

  5. How are group lead, group member and product changes handled through SRP registration?

     Please contact FAERSesub@fda.hhs.gov to change group lead, group member or products.

  6. Can a subsidiary unit register for an SRP account even though the parent company is submitting ICSRs through the ESG?

    Yes, you may register for an SRP account for your products only.

  7. What if I forget my SRP account password?

    Go to the Portal's Home page where you log in, and click the "Forgot your password?" link

    If you have tried to log in more than 3 times, the account is locked. Please contact the SRP support team by emailing at SRPSupport@fda.hhs.gov for password assistance.

  8. How often would our SRP Password need to be changed?

      The SRP password needs to be renewed and/or changed every 120 days. If a user attempts to log in beyond the 120 days a prompt will occur informing them to renew/change their password.

  9. How do I discontinue/disable any SRP account?

    Please contact the SRP support team by emailing at SRPSupport@fda.hhs.gov

  10. Does the SRP Account deactivate after a timeframe of inactivity?

    If you have not used SRP during the past 365 days or you cannot enter the reporting portal, your account may be deactivated. Please email SRPSupport@fda.hhs.gov to request re-activation of your account.

  11. What functional differences exist between the Group Lead and Group Members?
    • The functionality of the Group Lead and Group Members is the same within SRP (Case processing)
    • Group lead may view all reports initiated and/or submitted by a Group Member
    • Group lead is the Point of Contact (POC) for all inquiries related to SRP
    • Group Members may only view reports they have initiated, however they can view all submitted reports

Product Listing

  1. How can I add additional products to the Group Lead account?

    Please contact FAERSesub@fda.hhs.gov to add additional products to the Group Lead account.

  2. How can I remove products from the Group Lead account?

    Please contact FAERSesub@fda.hhs.gov to remove products from the Group Lead account.

  3. Do I have to provide the Product Name and the Product Active Ingredient (PAI) during the registration process?

    It is highly recommended that both Product Name and Product Active Ingredient (PAI) be provided for completeness of product information.

  4. How should the Structured Product Label (SPL) be handled during the Product registration process?

Submit a copy of the SPL for the registering product or supply a link (s) to the SPL for the product being registered.

Technical Questions

  1. Who should I contact for SRP technical issues?

    Please contact SRPSupport@fda.hhs.gov.

  2. What if the SRP is down? Can we submit an ICSR on a paper FDA form 3500A?

    If the website is unavailable, please contact SRPSupport@fda.hhs.gov for directions.
    While the SRP is unavailable, you cannot submit an ICSR on a paper FDA form 3500A. As of June 10, 2015, FDA no longer accepts reports on the paper FDA form 3500A.

  3. My company is currently submitting ICSRs through the Electronic Submission Gateway (ESG). Can I use SRP if I am unable to submit via the ESG?

    No, the SRP is for companies who are not set up for database-to-database (E2B) transmissions of ICSRs. Please follow the ESG back-up method (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072369.pdf).

  4. What if my SPL Product Name exceeds 70 characters?

    Although you must provide the full SPL product name when registering for the SRP, the system will automatically truncate your product name to 70 characters.

  5. What if each individual ingredient name exceeds 100 characters?

    If your ingredient name exceeds 100 characters, please truncate it to meet the 100 character limit.

  6. After a period of inactivity will the SRP session timeout?

    Yes, the SRP session will timeout after 20 minutes if no activity is performed.  Log in is available immediately after the timeout however you will not be able to access your unfinished report for 20 minutes. Data already entered will be saved.

  7. Is there a testing phase or opportunity to test related to SRP?

There is no testing aspect associated with SRP usage.

Report-Related Questions

  1. Who should I contact for report content and data issues?

    For these issues, please contact FAERSesub@fda.hhs.gov.

  2. Do I need to attach a copy of a MedWatch 3500A form/CIOMS form to my ICSR report?

    There is no need to attach a copy of a MedWatch 3500A form/CIOMS form to a submitted SRP case report.

  3. How can I submit a follow-up ICSR?
    • If you would like to submit a follow up ICSR, please select the most recently submitted ICSR for that case and select the follow up option. You may add or correct information. 
    • If your previous ICSR was submitted on a paper FDA form 3500A/CIOMS form, you must use the same Manufacturer Control Number (MCN) in order to create a follow up report using SRP. Do not use the E2B format of MCN/Report ID for a follow up on an initial paper submission.
    • Do not add Version numbers to the MCN.

    Note: If the same MCN is not used then the follow up ICSR will be created as a new “initial” ICSR.

  4. How can I submit an attachment for an ICSR?
    • When adding an ICSR, select the “Attachments” menu item from the left side of the page. Attachments must be submitted as PDF documents.
    • Please note that ICSR attachments can only be submitted with your ICSR. You cannot submit attachments separately from an ICSR.
    • Study/Literature reports and OTC label(s) being submitted must accompany an ICSR submission.
  5. If attachments are being submitted with a case into SRP are there size limitations?

    SRP can receive attachments up to 25MB. If a larger attachment is to be submitted then it is recommended you contact FAERSesub@fda.hhs.gov.

  6. How do I submit an attachment to a previously submitted ICSR?

    Submit a follow-up ICSR with the attachment.

  7. Can I batch ICSRs in one submission?

    No, ICSRs must be submitted individually.

  8. How can I make corrections to a previously submitted ICSR?

    If you submit an ICSR in error or need to make corrections, please submit a corrected follow-up ICSR.

  9. How can I nullify a previously submitted ICSR?

    If you would like to nullify a previously submitted ICSR, please submit a follow-up ICSR and indicate in the case narrative that you are nullifying the ICSR and the reason for the nullification.

  10. How can I enter a compounded product as a primary suspect product via SRP?

    To enter a compounded product as the primary suspect product:

    • Navigate to the Primary Suspect Product screen
    • Under the “Primary Suspect Product Information” section select “Product name” as “Other” from the drop down list
    • “Please describe” field will appear below the “Product name” field
    • Enter the compounding product name in the “Please describe” field
    • Enter the value COMP99 for the field “Drug authorization number (Enter COMP99 for compounding product)”
    • For a multiple ingredient compounded product, list each ingredient individually following the steps above. Do not list all the ingredients on line in a concatenated fashion.  
  11. How can I enter a primary suspect product that is not in the “Product name” drop down list?

    To enter a primary suspect product that is not in the “Product name” drop down list:

    • Navigate to the Primary Suspect Product screen
    • Under the “Primary Suspect Product Information” section select “Product name” as “Other” from the drop down list
    • “Please describe” field will appear below the “Product name” field
    • Enter the product name in the “Please describe” field

 

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