White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 6: Clinical Research and Investigator-Initiated Research
If a physician asks you about compassionate use of a Pfizer product, refer the inquiry promptly to Pfizer
Medical Information. The Pfizer Medical Colleagues assigned to the relevant drug are the only
individuals at Pfizer authorized to approve compassionate use requests. Remember, you must never
discuss unapproved products or indications with HCPs, and you must direct all requests to Pfizer
Medical Information or to the appropriate RMRS.
Responding to Requests from HCPs Regarding Medical Research
You may be asked by HCPs for information on being a clinical investigator for a Pfizer clinical trial or to
provide financial or other support for their independent medical research. Because these requests
often involve requests for compensation, how you respond has both federal and state healthcare law
implications.
Responding to Requests to be a Clinical Investigator
Not all interested HCPs will qualify to be clinical investigators. In addition to requiring appropriate
expertise and training, being a clinical investigator may require a significant financial investment. For
example, the HCP may be required to make changes to his or her office to accommodate research
patients, study monitors, additional equipment and secured storage for both drugs and files. The HCP
will also need to have knowledge of informed consent and patient protection issues.
For more information on managing an HCP’s expectations about clinical trials, go to the “Clinical
Investigator Submission Tool” at http://fieldsites.pfizer.com/pfieldnet/MI/MAG.asp. There you may
register the HCP in Pfizer’s investigator database and order the So You Want to Be a Clinical Investigator
pamphlet (publication ID WX269X01) to provide to HCPs interested in learning more about the
application and funding process.
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