IN PARTNERSHIP
including age and disease/healthy volunteer and the main exclusion criteria to protect the subject, eg, patients with moderate asthma 18 – 55 years with normal kidney and liver function and without gastrointestinal ulcer or risk factors for a cardiac arrhythmia; healthy volunteers 18 – 60 years not exposed to X-ray examinations during the past 12 months. 8. Interventions: describe interventions and treatment duration, also including background treatment if any, eg, one group receives a 10mg tablet of Product X twice daily for X weeks while also receiving Product Y as background treatment, and the other group receives a placebo tablet twice daily as well as Product Y. Also describe trial-related diagnostic and monitoring procedures used. 9. Ethical considerations relating to the trial, subject or group of patients represented by the trial subjects, as well as the nature and extent of interventions, explaining if the trial involves an should be given. If a non-therapeutic trial is carried out in vulnerable groups, eg, in minors, incapacitated persons, pregnant or breastfeeding should be explained why the risks and burden are considered minimal and why the trial can only be performed in this particular group. The therapeutic and monitoring procedures should samples, the number of site visits, physical examinations or other tests, as well as the physical and physiological discomfort associated with trial participation. Furthermore, unlike the Lay Summary of Clinical Trial Results, the Protocol Synopsis has
Challenges Aside from the general challenges of writing the scope of this article), there are a number of
12 | Outsourcing in Clinical Trials Handbook “The Protocol
Synopsis could form a great basis for the Lay Summary of Clinical Trial Results”
There is no guidance about how much
background should be given in section 2, or how many secondary objectives should be given them should be included). The objectives, main, and secondary trial end and 5) can be very complex and take a large amount of space to explain in plain language, a problem that is compounded by the time frame of the assessments. The trial design complex and potentially confusing, and are often best explained using infographics, which can work well but do take up a lot of space.
exclusion criteria to be described, which can be extensive, involving clinical and technical terms and assessment criteria. A description of the inclusion and exclusion criteria in clinical regulatory language often takes a page alone often necessary to explain concepts in plain description of the background treatment and trial-related diagnostic and monitoring lengthy depending on the therapy area. would be extremely challenging to condense into a meaningful, plain language document.
Conclusions
Considering that the guidance on the a page and a half on its own, and that in general explain complex concepts in plain language,
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