A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring and quality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis methods, as well as a justification.
Achoimre ar an bplean don imscrúdú cliniciúil lena gcumhdófar cuspóirí, dearadh, gnéithe eiticiúla, bearta faireacháin agus cáilíochta, critéir roghnúcháin, an spriocphobal othar, méid na samplála, sceideal na cóireála, fad na tréimse oibre leantaí, na cóireálacha gaolmhaireachta, an plean staidrimh lena n-áirítear hipitéis, méid na samplaí a ríomh agus modhanna anailíse chomh maith leis an mbonn cirt a ghabh leis an imscrúdú.