Institutions can adapt to the proposed changes in Conflict of Interest Reporting by examining their use of configurations within the Conflict of Interest module:
Definition of Significant Financial Interest:
- Codes and Tables to define the types of external activity, to distinguish activities where income is specifically excluded from the requirement, but is still captured in disclosure
- Codes and Tables to define the types of external income, to identify payments and equity interests
- Attributes captured for each external activity, to determine cumulative impact of financial interests
- Attributes captured for each external entity, to identify organizations where income is specifically excluded from the requirement, but is still captured in disclosure
Requirements for Investigator Disclosure:
- Forms designed to instruct and guide the investigator, to ensure complete reporting of external interests
- Review process that grants visibility into both the disclosure as well as all relevant research activity, to determine if Significant Financial Interest is Financial Conflict of Interest
Requirements for Public Disclosure:
- Codes and Tables to define review outcomes, to distinguish activities determined to be reportable Financial Conflict of Interest
- Web Services or Queries to extract information on relevant research activity and Financial Conflict of Interest which must be posted on a public web site
Requirements for Conflict Reporting:
- Codes and Tables to define review outcomes, to distinguish activities determined to be reportable Financial Conflict of Interest
- Web Services or Queries to extract information on relevant research activity and Financial Conflict of Interest which must be posted on a public web site
Requirements for Investigator Training:
- Training and Certification for each investigator tracked within their profile
- Expose current status and expiration of certification in other modules
By considering how business rules can be driven by clear definition of certain values in the system, institutions can ensure that sufficient information is available to satisfy both internal and external requirements.
