MARKET RESEARCH PROGRAMS AND PATIENT SUPPORT PROGRAMS Clause Samples
The 'Market Research Programs and Patient Support Programs' clause defines the terms under which parties may conduct market research or provide support services to patients in connection with a product or service. It typically outlines the scope of permissible activities, such as gathering feedback from healthcare professionals or offering educational resources to patients, and may specify requirements for compliance with applicable laws and data privacy standards. This clause ensures that such programs are conducted transparently and ethically, mitigating legal and reputational risks for the parties involved.
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MARKET RESEARCH PROGRAMS AND PATIENT SUPPORT PROGRAMS. Market Research Program (MRP) refers to the systematic collection, recording and analysis of data retrieved from the market about the Product, relevant for marketing and business development. For this purpose, the MRP can be conducted using materials such as questionnaire, survey, interview which could include questions and/or answers leading to a safety case report. A Patient Support Program (PSP) is an organized system to receive and collect information relating to the use of the Product. It corresponds to a service for direct consumer, or patient caregiver interaction/engagement designed to help in the management of medication and/or improve disease outcomes or to provide health care professionals with support for their patient. Examples are post- authorisation patient support and disease management programs, surveys of patients and healthcare professionals, information gathering on patient compliance, or compensation/re-imbursement schemes. The Vigilance Department of CMS shall be informed of any MRPs or PSPs performed by the Marketing Department of CMS and shall be involved in the implementation, contract writing, materials elaboration and follow-up process. Personnel involves in MRP/PSP including third party shall be trained to safety data collection. When transfer of safety data occurs within an organization or between organizations having set up contractual agreements, a process shall be implemented to ensure confidence in the well exchanges of all notifications. In that matter, a confirmation of receipt and/or reconciliation process shall also be undertaken. CMS shall inform BIOCODEX of any MRPs and/or PSPs conducted with the Product by CMS in the Territory. The list of BIOCODEX contacts that must be informed is reported in Appendix 3.0. The Vigilance Department of CMS is responsible for identifying any ADR or special situation issued from MRPs and/or PSPs and to handle it as described in section 6 of this SDEA. If neither BIOCODEX nor CMS is the sponsor of a program conducted with the Product in the Territory, and CMS is aware of any case safety report which occurred with the Product during a MRP/PSP in the Territory, this AE report will be processed as described in section 6 of this SDEA.