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Compensation to Investigators in Clinical Studies
Effective September 3, 2013
1. Purpose & Scope
The purpose of this clinical and medical controlled document (CMCD) policy is to describe the requirements for payment to investigators and/or their institutions for work associated with the conduct of Pfizer-sponsored studies. The term policy will be used throughout the remainder of this CMCD policy.
This policy applies to:
- Compensation to investigators and/or their institutions for all new and ongoing Pfizer-sponsored studies.
- Pfizer colleagues who are involved in activities related to the policy, as well as to those parties with whom Pfizer contracts (e.g., contract research organizations, vendors or consultants) to perform such activities, unless Pfizer has agreed that such parties may follow their own processes with respect to these activities.
This policy does not apply to:
- Investigator-Initiated Research .
- Pfizer Clinical Research Unit (PCRU) Investigators. If the PCRU contracts an investigator to be principal investigator or sub-investigator in a particular study, the provisions in this policy will apply.
2. Policy Statements
This policy sets forth minimum standards with regard to compensation of investigators in Pfizer-sponsored studies and implements the Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.
Compensation to an investigator and/or their institution must comply with the following policies:
- Pfizer Global Policy on Interactions with Healthcare Professionals
- Pfizer Corporate Policy #202, Anti-Bribery and Anti-Corruption, Pfizer Corporate Procedure #215, International Anti-Bribery and Anti-Corruption Procedure
- Pfizer Corporate Policy #304, Global Meetings and Congresses Policy and Procedure
- For studies sponsored by Pfizer Worldwide Research and Development (WRD), excluding Pfizer Consumer Healthcare (PCH): Pfizer WRD SOP #201, WRD Anti-Corruption, GPIHP, and External Funding Controls
Pfizer compensates investigators for their work in conducting Pfizer-sponsored studies and for providing protocol-required services to Pfizer related to those studies. Such compensation must be fair, reasonable, and equitable to fair market value for such work. The rate of compensation may take into account factors such as required procedures, time commitment, study complexity, and locale.
Any compensation to investigators as part of the study must be explicitly identified in the study budget. Any services performed by an investigator outside of the study (e.g., consulting services or speaking engagements) may not be included as part of the study budget and must be documented in a separate agreement. Refer to CT21-GSOP Establishing and Managing Committees That Perform Adjudication, CT22-GSOP Use of Data Monitoring Committees and Conduct of Interim Analysis and CT43-GSOP Study Country and Investigative Site Selection for specific restrictions on services that may be provided by investigators.
- Pfizer does not provide financial compensation to investigators for the conduct of studies in the form of consulting agreements or honoraria. Financial compensation for consulting or other services related to the study or the research program and not directly related to investigator study conduct is acceptable, but must be appropriately documented and must also adhere to the Pfizer WRD SOP #201, WRD Anti-Corruption, GPIHP, and External Funding Controls.
Pfizer has the following additional requirements for compensation to investigators:
- The financial compensation to investigators and/or their institutions must be linked to their performing specific and necessary services (e.g., medical procedures, collection of data).
- Notice of the financial relationship between Pfizer and the investigator/institution must be disclosed to the subject in the informed consent. Such disclosure must consist of a statement such as the following: “The investigator or his/her institution is receiving compensation from the study sponsor for the investigator’s participation in this study to meet the costs associated with running the study”.
- The financial compensation must be specified in a written contract describing the nature of the research services and the basis of payment.
- The financial compensation must be reasonable relative to compensation for similar studies sponsored by the pharmaceutical/biotechnology industry in the country where the research is conducted. It may include reimbursement for reasonable travel, lodging, and meal expenses when investigators or their staff must travel to meetings for a study. Venue and circumstances for meetings must be appropriate for the purposes of the meeting and will not include recreational or entertainment events.
Financial compensation to investigators and/or their institutions or other study site personnel shall not:
- Be tied to the outcome of studies.
- Include Pfizer stock or stock options.
- Include payments to physicians outside a study for referring subjects to investigators for entry into that study.
- Include honoraria, travel, or lodging expenses for those not involved in the study.
- Include special incentives such as enrollment bonuses, awards, or gift certificates that are designed to reward the achievement of subject enrollment goals within a specified time period.
- If enrollment in a study is particularly challenging, Pfizer may compensate investigators, their institutions, or other study site personnel for extra recruiting expenses to enroll appropriate subjects. For example, compensation may cover such expenses as additional advertising costs.
- Include advance payments in the United States.
- If an advance payment is required by law in a country or is a commonly-accepted practice in a country, it may be permitted if all of the following conditions are met:
- The advance payment is approved by the relevant business unit, including Finance and R& D Legal.
- The contract language documents when and how advance payments are reconciled and the institution’s obligation to refund unearned payments to Pfizer.
- There is a process in place for recouping any unearned payments.
Investigators or their immediate families shall not have direct ownership interest in the specific pharmaceutical product being studied. This provision does not preclude direct ownership of Pfizer stock.
Pfizer may publicly disclose compensation to investigators in studies.
The study manager or equivalent, in conjunction with the outsourcing lead (OL), is responsible for compliance with this policy. If a country-validated per-subject cost range has been established for a particular study, all compensation rates outside that range must be justified to verify the cost is fair market value and approved by the relevant business unit, including Finance and documented. The OL is available for consultation when exceptions to compensation rates are being considered by project teams.
For studies sponsored by PCH, the responsibility for compliance will reside with PCH clinical operations with support from the procurement lead assigned to support PCH. For studies conducted in a PCRU, the responsibilities are managed at the PCRU.