There is a Medical tourism platform from English to Arabic. A whole series of actors participate in a clinical trial, where each of them plays a well-defined role according to current regulations. The ultimate purpose of all of them consists of the collection, review, and analysis of medical data that allow a clear evaluation of the study objectives defined in the trial protocol.
Applied to the area of clinical research, good quality is everything that will lead us to obtain convincing clinical study results from the scientific point of view, while poor quality would be everything that would lead us to obtain results in which we cannot be sure that the conclusions reached are correct.
Below we will detail what each of the actors involved: research team, principal investigator, pharmacy personnel, study promoter, CEIC (Clinical Research Ethics Committee) and monitor; they can and are obliged to do for the pursuit of excellence.
In the first place, the research team that has agreed to participate in the study is responsible for the patient’s medical care while they are there. This equipment contributes to the quality of the trial, in the following way:
- Complying with the requirements of the protocol approved by the CEIC and AEMPS (Spanish Agency of Medicines and Health Products), avoiding any deviation from it and complying, at the same time, with the standards defined in the Good Clinical Practice guide and also in the applicable regulations.
- Obtaining, signed correctly, the Informed Consent of a patient who has agreed to participate in the clinical trial, before performing any procedure related to the study.
- Reflecting correctly in the patient’s clinical history, everything that happens to him / her during the clinical trial (if there are adverse events due to the use of the medication, if it is taken according to the instructions, if the diaries are correctly completed) patient in case of existing, etc.), also detailing those errors that can be committed, always bearing in mind that everything that has not been documented has not happened and will be interpreted in the event of audit or inspection of the clinical trial.
- Finally, keeping the Archive of the Investigator updated, keeping it and avoiding its premature loss. This file contains the essential documentation of the study (relevant correspondence between promoter and research center, authorizations of CEIC and AEMPs, a protocol of the study and its amendments, etc.)