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COMPLIANCE


ARE SOCIAL SURVEYS CONVERSATION CHECKED FOR ADVERSE EVENTS AND WHO IS RESPONSIBLE FOR ADVERSE EVENT REPORTING?

No, Social Survey conversation data presented in the client portal is not checked for any Adverse Events by SERMO, nor is SERMO responsible for AE reporting for any of its social media listening products.

Social Survey conversations should not be considered market research data as conversations on SERMO are secondary, user-generated content pulled from discussions on SERMO. These conversations are not directly responsive to specific market research inquiries and may or may not be related to the topic of any market research survey.

Additionally social media listening as part of Social Surveys is not live data that healthcare clients can read in real time.

 

DOES A MARKET RESEARCH ORGANIZATION HAVE TO MONITOR FOR ADVERSE EVENTS DISCUSSED IN SOCIAL SURVEY CONVERSATIONS AND REPORT ANY ADVERSE EVENTS TO THE PHARMACEUTICAL COMPANY THAT COMMISSIONED THE STUDY?

Different jurisdictions have different requirements with respect to the requirements for reporting adverse event information discovered in the course of market research and social listening activities.

Regardless of the reporting requirements in any particular jurisdiction, some commissioning pharmaceutical companies may – by contract – require that market research organizations report adverse event information found in market research data to the commissioning company.  MROs may want to determine a commissioning company’s stance on reporting adverse event information found in social media listening conversations.

Social Survey conversations should not be considered market research data as conversations on SERMO are secondary, user-generated content pulled from discussions on SERMO. These conversations are not directly responsive to specific market research inquiries and may or may not be related to the topic of any market research survey. 

WHAT ARE CURRENT GUIDELINES FOR MROS TO REPORT AES?

At least one U.S. organization, CASRO, in its Guidance on Adverse Event Reporting has taken the position that MROs should not be required to report AEs discovered during market research.

A European organization (ABPI) recommends the following:

  • An ABPI document entitled Guidance notes on the management of adverse events and prouct complaints from digital media, includes a section on social media activities that speci cally addresses social media listening (see Section 4.1, p.3). This section states:
  • If a company chooses to ‘listen in’ at non-company-sponsored sites, it is recommended that the relevant pages of the site should be monitored for AE/PC for the period of the listening activity only.
 

HOW DOES SERMO CHECK FOR ADVERSE EVENTS IN COMMISSIONED STUDIES?

All commissioned primary data is checked for Adverse Events using the following methodology: SERMO staff manually checks, on a daily basis (within 24 hours) all survey data and deals with them within 24 hours. Our staff is highly AE trained to report adverse events to clients. The AE is reported to the client by SERMO staff (within 24 business hours) and the client is then responsible for handling the AE.

WILL THERE BE ANY PHARMA ADVERTISING ON THE PAGE WHERE RESPONDENTS PROVIDE THEIR COMMENTS?

No.