Specifications include, but are not limited to: While it is anticipated that each CRO will outline specific activities, support functions, and process for engagement within its Master Services Agreement, or similar agreement document, common expectations for CRO support to CRH include: 1. Identification and presentation of clinical research studies to the CRH team; 2. Assistance in interpreting “fit”, site feasibility, and specific requirements of a given study; 3. Assistance in negotiating payment for each study; 4. Assistance in training CRH key staff on research knowledge “gaps” that might exist (e.g., specimen collection, storage, shipping); 5. Assistance in understanding requirements for management of research data and secure transfer procedures; 6. Assistance with compliance issues (e.g., informed consent, HIPAA standards, mandatory reporting); and 7. Assistance with other related to conducting a robust high-quality clinical research program. 8. Should the CRO require an interfacing tool with the electronic health record used to mine patients for clinical research studies, the CRO must be approved by MUSC Health for integration with the MUSC Health contracted Epic Connect electronic health record for CRH clinical care and research documentation. 9. Ease of doing business with bidder, and lack of additional compliance burdens. 10. Clemson University will negotiate research agreements directly with each pharmaceutical and biotech company or through CRO 11. Clemson University reserves the right to refuse a proffered study or trial if Clemson University, CRH does not have the resources or the trial is not relevant to the Clemson University/CRH strategic mission. 12. Please also list any additional assistance that CRO may also provide. For example: a. access to research studies and clinical trials; b. regulatory and ethical support; c. specimen collection protocols or their development; d. standardized operating procedures (“SOPs”); e. questionnaires; f. recruitment; g. training, specimen lifecycle and data management; h. committees and/or working groups; i. quality oversight; j. branding, marketing, distribution; k. IRB approval and other compliance support; l. periodically review levels of participation; and coordination, including managing the consent requirements for each study or trial.
