White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 6: Clinical Research and Investigator-Initiated Research
Referring Physicians to be Clinical Investigators for Pfizer-Sponsored Studies
No Assistance with IIR Protocols
Q. As part of our overall plan to improve Pfizer’s relationship with a key institution,
my team wants to alert qualified physicians to (non-IIR) Pfizer-sponsored
research opportunities. Is this OK?
A. Yes. It is permissible to encourage physicians who, based on their training and
experience, would be appropriate investigators to seek out opportunities to
participate in Pfizer-sponsored studies. It would not be permissible, however,
to encourage Pfizer Medical Colleagues to select these physicians to be
investigators or show them any special treatment. Decisions on who shall be
engaged as clinical investigators must be based on the physicians’ expertise,
training, and other relevant factors, such as availability of appropriate facilities
and staff, and access to the target population of study participants, and not on
their potential prescribing of Pfizer products.
All protocols for IIR studies must be written by the sponsor or principal investigator, not by Pfizer.
Colleagues may not write protocols for independent investigators. If you receive a request from a
sponsor or principal investigator for assistance with this process, you must direct the applicant to the
Pfizer Medical Division.
No Assistance with Patient Recruitment
It is not appropriate for members of Pfizer’s sales force to assist investigators in recruiting patients for
Pfizer-sponsored studies or IIR studies. Similarly, it is not permissible for you to offer additional
compensation to an investigator in order to offset higher than expected recruitment costs. Any
requests for additional funding must be made directly to the Pfizer Medical Division.
Collaboration with Physicians on Questionnaires and Surveys
Q. May I provide protocols for surveys, data collection tools, or other materials to
my physicians to help them conduct patient research about different
interventions?
A. Yes. You may provide only those protocols for surveys, data collection tools
and other materials that have been approved for promotional use by a Pfizer
Review Committee. You are prohibited, however, from customizing any
approved material for particular physicians or institutions unless such
customization is also approved by a Pfizer Review Committee.
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Rev. 09/12
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