Clinical investigators meetings

The Directives provide that devices may be placed on the market and put into service only if they comply with the requirements laid down in the Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. Devices, other than devices that are custom-made or intended for clinical investigations, that are considered to meet the essential requirements set out in Annex I of the relevant Directive must bear the CE marking of conformity when they are placed on the market. ... 

The NHS Trust represents that the Site Principal Investigator has the necessary expertise to perform the Clinical Trial and that the Site Principal Investigator meets and will continue to meet the conditions set out at Appendix 6 to this Agreement. 

The formulation, manufacturing process, analytical development, and long-term toxicology studies in animals are parallel to the clinical investigation (Table 1.1). Clinical trial materials should be developed, manufactured, tested, and released before conducting a phase I clinical trial. Process chemists may redesign the synthetic route for the dmg candidate to meet the requirements of large-scale production in a pilot plant. Preformulation scientists complete the activities of salt selection,... 

As noted in the previous section, the FDA s review of phase 1 submissions focuses on assessing the safety of those investigations. The review by the FDA for submissions of phase 2 and 3 trials will also include an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval. 

Management of clinical study conduct Protocol writing Site selection Investigator meetings Monitoring... 

Dueymes, M. D., Fournie, G. J., Carentz, F., Mignon-Conte, M. A., Labarre, J.-F., Conte, J. J. Europ. Soc. for Clinical Investigation, Annual Meet., April 17-19, 1984, Milan, Italy (Abstract)... 

Investigator meetings can be held only for participants of clinical trials which are conducted consistent with Good Clinical Practice and which were either approved by or notified to StJKL. 

In addition to such forms of publication, it should be noted that health authorities in the United States and other countries are also informed as to the design and goals of all clinical trials conducted by pharmaceutical companies, and are sent final protocols prior to the study investigator meetings. This allows time for these health authorities to comment on the same and suggest modifications to the design of trials, if needed, based on their specific scientific goals. In addition, communication of safety... 

May well have views about the type of studies and the best investigators - they may decide where the clinical trial is conducted Wants a say in final study design Likes to attend investigator meetings (usually unannounced)... 

Investigators meetings are often regarded as indispensable to the success of a clinical trial, and can be efficient ways to train large numbers... 

---