Replace Radio Button in the Clinical Trial Agreement and eSign it in minutes

Aug 6th, 2022
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How to Replace Radio Button in the Clinical Trial Agreement

4.9 out of 5
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hey everyone its dance fair from the clinical trials guru back with yet another video every day I try to do more than one a day but today Im doing this one its a pretty special video somewhat important as I tell you guys all the time you especially you research clinics but this doesnt just apply for to research clinics it applies to everybody in this industry whether you work for a CRO whether youre a p.i wanting to network with other p is whether your site director of a research clinic even sponsors its so important in this industry to network with your colleagues even if its from competing companies even the Big Pharma is doing this now youre seeing a lot of collaboration going on between Big Pharma so theres no reason as research sites should not be able to do this so Im part of of several groups on LinkedIn there are some Google Plus groups theres my special cyber dusters for those of you who dont know cyber dust is an app you can add me dance vera im planning to start

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Legal representative requirements under CTR ing to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, then they are required to appoint a representative within the EU to act as a Legal Representative.
Article 58Archiving of the clinical trial master file The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.
Article 61Authorisation of manufacturing and import The manufacturing and import of investigational medicinal products in the Union shall be subject to the holding of an authorisation.
Article 57Clinical trial master file The clinical trial master file kept by the investigator and that kept by the sponsor may have a different content if this is justified by the different nature of the responsibilities of the investigator and the sponsor.
Article 61Authorisation of manufacturing and import The manufacturing and import of investigational medicinal products in the Union shall be subject to the holding of an authorisation.
Article 57Clinical trial master file The clinical trial master file kept by the investigator and that kept by the sponsor may have a different content if this is justified by the different nature of the responsibilities of the investigator and the sponsor.
(56) The requirement to hold an authorisation for manufacture or import of investigational medicinal products should not apply to the preparation of investigational radiopharmaceuticals from radionuclide generators, kits or radio nuclide precursors in ance with the manufacturers instructions for use in hospitals
Article 61(5) of the Clinical Trial Regulation (CTR) (EU Regulation 536/2014) provides an exemption from the requirement to hold a manufacturers authorisation for the following processes, where they are carried out in a hospital, health centre or a clinic participating in the clinical trial; a) Re-labelling or re-

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