All reviewers making public comments must provide complete and accurate disclosure statements of their relevant relationships with industry. RWI will be reviewed when considering comments and may be disclosed publicly. In the space provided below, all reviewers must disclose ALL relevant financial, personal or professional relationships with industry, individuals, or organizations as defined below (including such relationships of their spouse and dependent children). Please identify relationships within the last ONE year that could be relevant to the topics or issues addressed in or implicated by these PICOTS questions.
A person has a relevant relationship with a company or other entity IF:
The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or
The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or
The person or a member of the person's household, has/have a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.
All such relevant relationships should be noted and the financial disclosures should be classified as significant, modest, or no financial relationship.
A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person's gross income for the previous year.
A relationship is considered to be modest if it is less than significant under the preceding definition. No financial relationship pertains to relationships for which you receive no monetary reimbursement.
If an individual has no conflicts or relationships to disclose, he or she must indicate none.
In the space provided below, please indicate relevant financial, personal or professional relationships with industry, individuals, or organizations for the different categories. If you have no relevant relationships, please enter NONE. Please address all bullet points mentioned above.