Requirements The participation requirements may vary from one study to another. In general, men and women of legal age, in possession of their mental faculties, non-smokers or consumers of alcohol or drugs of abuse, who are not receiving prescription medication and have not donated blood or participated in another study with investigational drugs, may participate. Recently. You can not participate if you have a history of allergies to medications. In the case of women, they should also avoid pregnancy during the duration of the study using a non-hormonal contraceptive method of proven efficacy. Participants must give their consent in writing before beginning any study procedure.
Information and consent. Candidates wishing to participate in a clinical trial should first obtain information. A doctor of the research team, in an informative meeting, will provide you with an information sheet and informed consent to read and sign and will explain the design, the purposes of the project, the possible risks that may arise and that may at any time deny your collaboration . The consent information is the best source of information, if after reading it carefully some aspect is not clear do not hesitate to ask the doctor of the research team. To assess your health status, a clinical history, a physical examination, vital signs, electrocardiogram and a series of blood and urine analytical controls will be performed. After a few days, if all the tests are normal and you meet the inclusion criteria specified in the study protocol, you can participate in it.
The trial usually consists of two or more periods of income of a variable duration, between 12 and 48 hours, separated by a period of time between income and income. Each of the days of monitored admission will be administered the study formulation and a series of controls are performed (eg vital signs, blood extractions or collection of urine samples) before and after the administration of the formulation. Each day of admission you will be supervised by doctors and nurses, members of the research team. Finally, before completing the study, the initial clinical and analytical controls will be repeated.
Compensation for participation. Participation has a compensation that varies depending on the time and overall duration of the study.
If you want more information you can consult our page About Clinical Trials.
Facultad de Medicina de la Universidad Autónoma de Madrid. Calle del Arzobispo Morcillo 4. 28029 Madrid. Tel. +34 91 497 54 86 Fax. 91 497 53 53. Email. informacion.medicina@uam.es
