Observational Study Agreement Template

For all clinical trials and clinical investigations (including CTMS, hardware testing, etc.), an agreement signed between the promoter and the host organization is expected before the start of the site search. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations. Appropriate data processing agreements should be concluded using the appropriate agreement model: when a proposal is submitted on the basis of the model agreement, but contains amendments, the proponent should explain the reasons for it. For HRA-authorized studies, HRA`s initial evaluation letter (and HRA authorization letter) specifies the corresponding agreement for each type of site in a study. The document may refer to the declaration of activity and the timing of events, to a model of agreement (for example. B mCTA) or another sponsor document. If you are applying for HRA authorization for your study, you may also find it useful to refer to the standard document and HRA evaluation criteria, as this includes reflections on the use of model agreements. You can find the document on our HRA special approval page. Hello, Nazish, and welcome to the network. The items here are downloadable templates to use for you; Looks like you`re looking for e-learning courses and courses? If so, no problem! Free seminars with sound and slides are available here: globalhealthtrials.tghn.org/elearning/e-seminars-new/, and you`ll find free and certified online learning courses here: globalhealthtrials.tghn.org/elearning/other-resources/. For e-learning courses, certificates are issued to those who, at the end of each course, occupy more than 80% of the quiz. If you need anything else, ask! Art. 2001The Editorial Team The Health Research Authority (HRA) in England and health services in the Devolved Administrations expect sponsors (and CROs) to use the February 2018 MCTas without modification and in accordance with guidelines when entering into contracts with NHS/HSC organizations to conduct industry-sponsored studies.

Similarly, NHS/HSC organizations are expected to accept unchanged MCTAs without re-reviewing standard models. National site location agreements help speed up the process of awarding trials in the NHS supported by industry, as there is no longer a need for site-by-site controls and local legal agreements.