What should be contained, according to the ICH, the medical history of a patient who participates in a clinical trial.

The visit in which a patient is included in a clinical trial must include at least the following information which for example would be; included in the clinical trial patient: title ” with code protocol code. The patient is informed on the study, gives its consent _ / _ / _ day and delivered copy of the same. He is assigned the following number of patient: — —- and was randomized to the Group — — — — (control/treatment), with the following number of randomización — — — — —-.

There is a first visit, called the visit of selection in which the patient signed informed consent in the majority of clinical trials. It is included on the basis of the information available until his signing, when it meets most of the verifiable selection criteria at that time. Once the patient has given consent, should be done all the tests described in the Protocol to verify that the patient meets all the criteria for inclusion and none of of exclusion is often a window of 15 to 30 days in which is expected to suffice for the programming of all evidence and especially in which it is possible to have the results for the randomization of the patient. With exceptions, it is impossible to be able to include a patient and is randomized in the same day. When a researcher signs a form of randomization, it is noted that it has all the necessary results for the verification of the selection criteria and that therefore the patient meets all inclusion and none of the exclusion criteria authorizing the randomization of the patient. If the randomization of an essay form, called for a series of fields based on the classification of disease, special interest in not commit any error in the selection of them, carefully reviewing the history prior to the randomización, that it may be a bias in the randomization process should be. If finely, based on the results, the patient not fulfill some criteria of selection, would be considered a selection bug ” and thus must be notified to the Centre Coordinator of data and/or promoter.

A practice common among researchers, we include a patient for example with a previous count/biochemistry/serology and although you are prompted again during the visit of selection is randomized without knowing its outcome. This presents a significant risk, as it can occur, and thus often happens, that finally the patient has been incorrectly included. A test of the trial may be a date prior to the signing of informed consent, only and exclusively if so contained in the Protocol well because it proof invasive for the patient, either because the diagnosis of the disease is not changed at that time ……and always the window of days that the Protocol allows for the validity of these tests prior to the inclusion of the patient must be respected.

It is important to know that each and every one of the criteria for selection of the test have to be verifiable. If not met any of the criteria of selection or could not check, would be one deviation greater than the Protocol. At the time that the investigator, auditor or monitor detected one deviation greater than the Protocol, it must be notified to the promoter of an urgent because this may entail its withdrawal from the inmediate way trial by security. If it is finally decided that the patient will continue in the trial, he cannot be held to the analysis of effectiveness of the population by Protocol. One important difference between the population by intention and the population by Protocol (> 20%) it shows a bad follow-up to the Protocol and could be questionable if the results obtained for the intention of trying to be for a population described in the Protocol inicialemnte.

During the visit of selection is you must ask the patient for concomitant medication that you have indicated at that time and try to not drag errors that could come from previous report. This should correlate with those associated diseases have the patient in his basement visit. It will be equally important to have the dates in which they were prescribed in order to make a correct follow-up of the same approximate. Any changes that occur throughout the trial, not only by their underlying pathologies, but also for the treatment of any adverse event occurred during the study should be recorded in medical history. The patient should be given directions to inform their family doctor, if this is the case that are participating in a clinical trial.

In each of the visits, since the patient signed informed consent and usually 30 days after their withdrawal completion, you must register if the patient has had some adverse event. It is important that if it has not happened, it also appears that has happened any adverse event since his previous visit ”. The information sheet to the patient should include researcher contact details so that the patient can get in touch with ease with the researcher in the event of an adverse event.

En_relación_a analytical results in the visit of selection, must assess each of the parameters that are outside the range of normal from the Centre asterítico) indicating if it is considered clinically relevant ” or not clinically relevant ”. A clinically relevant in the basal time value, shall be regarded as basal sign/symptom and will be collected as concomitant prior history. If in follow-up visits, it is considered clinically relevant, it must appear as adverse event. Analytical of each of the visits reports must be signed and dated by the researcher as proof that have been revised to assessing the safety of the patient.

It is no less important to ensure correct accounting of the medication. Indications should be given to the patient that in each of the visit must carry surplus medication of the essay. The medical history should include if the patient has returned the medication, the excess medication and has been given new medication. Boaters, packaging, blister … .devueltos by the patient must be available to be reviewed by the monitor of the essay. If it can not check the traceability of the medication, can do these patients may need to be excluded from the analysis of effectiveness of the population by Protocol by not able to verify that at least 80% of the medication in trial has consumed.

Cristina Medina Achirica

Clinical Research Manager

group p-value