Clinical Trial Agreement Dcrf

If there is a clinical trials agreement, this agreement is part of the primary submission of the research dossier to the audit committee (MREC or accredited CCMO). The research sponsor may first submit an unsigned version. The submitted clinical trial agreement must have a reference and version number. The CCMO believes that the clauses relating to the early termination of the study and their publication in these models are consistent with the CCMO Directive on the Evaluation of Clinical Trial Agreements. If you submit a Declaration of Suitability for Location (VGO) to explain the local feasibility of the study, you must also submit a clinical study agreement in accordance with the new local feasibility procedure. Marieke Meulemans, CEO of GCP Central, said of the partnership: „The partnership between DCRF and GCP Central is the result of our successful collaboration in the development of e-learning through ECTR. DCRF`s network capability, combined with GCP Central`s operational excellence, has proven to not only be e-learning, supported by all clinical research participants, but ensures that this e-learning is easily accessible to all. I am proud of what our partnership has already accomplished and look forward to the future. While delays in implementation may have reduced the urgency to pay attention to this new regulation, this change sees a big difference in the way clinical trials are submitted and conducted in Europe. Setting up a multinational study should be simpler and faster in order to offer new treatment options to patients sooner, but to ensure that the EU remains an attractive place for sponsors to carry out new drug studies. In the attached cover letter, you must indicate whether the provisions evaluated by the evaluation committee have been modified in the signed research contract. This is based on the principle that the signed version must be the same as that approved by the review committee. We have partnered with the Dutch Clinical Research Foundation (DCRF) under a new 3-year distribution agreement to offer ECTR-E-Learning to current myGCP customers.

Through this collaboration, we will promote our own DCRF Academie e-learning pack to current customers and myGCP users, and we will in turn sell the e-learning packages internationally. . . .

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