This clinical study is being conducted at multiple sites under existing niaid-sponsored contracts and grants. NIAID will act as a sponsor of Investigational New Drug Application (IND). NIAID contractors, fellows, research networks, clinical research institutes or their auditors are not parties to this Agreement. NHS and HSC PICs should be established through a subcontracting agreement with the participating NHS and HSC organisation that the ICP supports. Appropriate data processing agreements should be adopted using the corresponding model agreement: the aim of Primary Care mCTA is to simplify and thus speed up the process of signing and initiating pharmaceutical and biopharmaceutical clinical trials on patients in primary care. The intention is for the primary care mCTA system to be used in a routine manner without modification by all pharmaceutical and biopharmaceutical industrial sponsors of clinical research, in which NHS patients are recruited into primary care. In such cases, no further legal review is required, saving money and time. The Health Research Authority (HRA) in England and health services in the demandised administrations expect sponsors (and CROs) to use the February 2018 MCTAs without modification and in accordance with the guidelines when entering into contracts with NHS/HSC organisations to carry out industry-sponsored studies. Similarly, NHS/HSC organisations are expected to accept unchanged MCTAs without further consideration of standard model elements. Revised in February 2018, the Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) models are designed to be used without modification for industry-sponsored studies of NHS/HSC patients in hospitals across the UK Health Service. This model agreement for clinical trials is established in collaboration between the vereniging of the topclinic opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON in order to facilitate the conduct of clinical trials in the Netherlands.
The termination and publication clauses are consistent with the CCMO Clinical Trials Agreement Evaluation Directive. The Clinical Trial Agreement model for primary care research sponsored by the biopharmaceutical industry (Primary Care mCTA) has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of very active general practitioners, the British Medical Association, the Medical Protection Society and the Uk Health Services. . . .