Archive for febrero, 2017

¬ŅCu√°ndo actualizar el FDA 1572?

viernes, febrero 24th, 2017

¬ŅTe has hecho esta pregunta cada vez que hay un nuevo investigador o se va uno que ya participaba?

A todos nos ha pasado que cuando hay un nuevo investigador lo primero que se nos viene a la cabeza es pedir su CV, a√Īadirle al delegation log, pedirle un financial disclosure y que el investigador principal firme un nuevo 1572 actualizado. Pero si vamos a las gu√≠as de la FDA sobre este documento, nos dice en el punto 7 que no hace falta:

7. When must a 1572 be updated or a new 1572 completed and signed by an investigator to reflect new or changed information?
There are two instances when it is necessary for an investigator to complete and sign a new 1572: when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study (21 CFR 312.53(c)). If there are other changes to information contained on a signed and dated 1572 (e.g., an IRB address change, the addition of new subinvestigators, the addition of a clinical research lab), the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update the IND. The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator. The sponsor can accumulate certain changes and submit this information to the IND in, for example, an information amendment or a protocol amendment.

¬°Espero que os sirva!