Confidential Steps for Completing the Financial Disclosure Form




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Confidential


Steps for Completing the Financial Disclosure Form
All investigators, co-investigators and sub-investigators listed on the 1572 must complete this form.
The top portion of the form should be completed with the information listed below a-f. The information may be printed on a hard copy of the form or typed on an electronic version of the form prior to printing.

a.Name of Protocol Investigator or Sub investigator – This name should match those listed in box 1 or box 6 of the form 1572

b.Site - Institution or site name associated with individual named above

c.Protocol Title – This should match the protocol name listed in box 7 of the form 1572

d.Protocol # - as assigned by NIH or NIDCR, if applicable this should match the protocol number listed in box 7 of the form 1572

e.Investigational Product(s) identified in the protocol. Multiple products can be listed on one form.



f.Pharmaceutical Co./Manufacturer(s) for Investigational Product(s) named above. Multiple companies/manufacturers can be listed on one form.
The five financial interest questions in the bottom table of the Financial Disclosure form must all be checked Yes or No, as appropriate by the Investigator or Sub investigator listed at the top of the form (see instructions step #1-a).
If any of the five financial interest questions are checked Yes, a statement addressing the nature and amount of the interest, arrangement or payment must be attached to the Financial Disclosure. Appropriate identifiers, i.e., protocol # and investigator name must be included on each document included in the submission.
A printed (hard copy) of the Financial Disclosure form must be signed and hand dated by the Investigator or Sub investigator listed at the top of the form (see instructions step #1-a).
Completed forms and any attachments must be retained in the Investigator Regulatory Binder. A copy of the Financial Disclosure form must sent to the Clinical Research Operations and Management (CROMS) contractor.
All information must be completed and each question must have an associated answer. Forms will be reviewed by CROMS for completeness; incomplete forms will be returned for correction by the Investigator or Sub investigator. Forms will be considered incomplete if appropriate blanks within the questions are not completed.
The financial disclosure information must be kept current for one year after the last study endpoint is reached.

Version 2.0 30 September 2010 Page of


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