The objective of this section is to document the agreement between the website and the promoter on the shelf life of the test data after the end of the trial version (usually at least two years). Effective July 1, 2009, the Health Science Center introduced new accounting and budget requirements; access to research.uthscsa.edu/ocr/clinical.shtml. This type of agreement can be initiated by a sponsor or reviewer. A clinical trial agreement, initiated by a sponsor, is required if the drug or device under review has financial support. A clinical trial agreement (“CTA”) is the legally binding agreement between a sponsor, usually a pharmaceutical laboratory that provides the drug or study apparatus and provides financial support, and the host institution, often an NHS hospital or trust, which provides data and results of interest. However, other parties may participate in the conduct of the trials, for example. B a contract research organization, clinicians, manufacturers, suppliers and, of course, volunteers for patients. The roles and responsibilities, and perhaps especially the liabilities of each party, must be clearly defined before a judicial proceeding is conducted. In the case of company-based minutes, sponsors generally make payments on the basis of cost per patient, with a payment plan based on intermediate stones of certain treatments/visits.
Other study fees (for example. B Pharmacy fees, patient recruitment fees, patient grants or fees related to certain procedures, such as pregnancy tests or radiological procedures) may also be paid separately from standard costs per patient. For minutes initiated by the investigator, sponsors usually indicate certain registration stones that must be reached before payment. Pay attention to the timing and requirements of the milestones. Payment plans can be attached to the contract as a table or narrative or as a paragraph in the contract. See below an example of a common payment plan for a study of 10 patients out of $2500/subject. If an examiner wishes to participate in an industry-sponsored clinical trial, preparation must be done on several fronts. On the other hand, sponsors and CROs are required to inform the IRB/EC directly of any infringements that may affect the safety and well-being of the subjects. To obtain a Project/Grant number from the Health Science Center for a clinical trial, the following documentation is required: a completed and signed Certificate of Proposal (COP), a copy of the study protocol, a written agreement signed between the sponsoring company and the Health Science Center, the approval of the Institutional Review Board (IRB), the first payment received by the sponsor.
The project will be implemented as part of the PeopleSoft 48002 fund group. It is important that all parties understand the language used in the treaty. When the agreement is revised, capitalized terms, restrictive words and words that are not understood are sought. The contract should have a definition section. Lead investigators should discuss all aspects of the clinical trial with their contract officer before negotiations begin. The involvement of the UCI faculty in the development of protocols and/or the organization of studies creates additional problems that both parties must tackle completely. It is therefore necessary to negotiate different or additional contractual terms. GENERIC DRUG ENFORCEMENT ACT Many agreements contain a clause requiring a certificate certifying that the lead investigator and other study participants are not excluded and have never been excluded under the Generic Drug Enforcement Act of 1992.