1. Statement of the Investigator (Form 1572) is the form that is required by the FDA.

Form 1572 is a contract with the FDA to follow Good Clinical Practics. Most pharmaceutical companies will provide a partially completed form but they are also available online. For more information about these forms, go to www.fda.gov and type "form 1572" in the search box. To obtain a form in PDF, go to www.fda.gov/cder/regulatory/applications/Forms.htm. Forward a copy to the CTO.

2. Curriculum Vitae

Typically, the CV must be current within two years and must be signed and dated. However, different funding agencies (i.e. NIH, Pharma, etc) have different expectations for the manner in which they are signed or updated. For instance, some require the date and signature on the cover page while others expect it on the last page. Forward a copy to the CTO Investigator Files.

3. Medical License

Attach a photocopy of your current medical license to your CV. When it expires, retain that copy and include the updated one. NEVER discard prior licenses.

4. Local Conflict of Interest Document

Also known as an AREPA (A Report of External Professional Activities) number.

For more information and to download a form, go to the Electronic Grants Management System Web site: egms.umn.edu/REPA. Forward a copy to the CTO Investigator File.

5. Sponsor Conflict of Interest Document

Form will be supplied by sponsor.

6. Local Laboratory Documentation

Pharmaceutical companies require documentation from the local laboratory even if they are using a central laboratory for the clinical trial. Again, it will be sponsor-specific but some of the typical documents are listed below:

• CAP/CLIA Certification
• Laboratory Director's current CV & Medical License
• List of Normal Reference Ranges

To obtain these items for this institute, go to www.fairview.org/prof/research/lab_accred.asp

7. Request for Taxpayer Identification Number and Certification

Some sponsors require submission of the W-9 Request for Taxpayer Identification Number and Certifcation form. A copy of this form can be obtained at www.ospa.umn.edu/sponsorrequireddocuments/index.html.