philgoddard Sep 20, 2017:

It could be something to do with "indeseable", undesirable.

Charles Davis Sep 19, 2017:

Just for the record... In Spain an IMP (investigational medicinal product), equivalent to IND (investigational new drug) is called a PEI (producto en investigación clínica) for registration/authorisation purposes by the AEMPS. I have just been translating an AEMPS document on this subject and it refers to "expedientes de PEI" in several places

Dr Jane Marshall (asker) Sep 19, 2017:

Yes, it is from Latin Americam, specifically, Chile.

Charles Davis Sep 19, 2017:

Source of doc.? Your text seems to be Latin American ("reportados", "droga"), so they might well be using American English terminology. IND is an American term; in Europe nowadays you would expect IMP, and "medicinal product" rather than "drug" is now standard in European legislation. Investigational New Drug Safety Reporting is a federal requirement for clinical trial drugs.

Dr Jane Marshall (asker) Sep 19, 2017:

@Charles Oh yes, that could be something! I will do a bit more research in that direction.

Dr Jane Marshall (asker) Sep 19, 2017:

More context The paragraph is small, and only contains what I wrote in the original query, but I will put what comes before and it in the letter. (Heading) and (bullet point) are my notes to indicate layout only. Thanks in advance for any contributions.

(Heading): INFORME DE AVANCE DEL ESTUDIO APROBADO POR EL COMITÉ DE ÉTICA EN FECHA XXX
(Below, bullet point): Status en el centro: (table of details on no. of pts enrolled & withdrawn)
(B. point): EVENTOS ADVERSOS SERIOS (SAE): sin eventos adversos
(B. point): Droga de Estudio: de la medicación de estudio...control de temperatura que se ha mantenido dentro de rangos...
(B. Point): Desviaciones: han sido informados en forma oportuna a su respectivo comité de ética.
(B. point): INDS o Susars: Han sido reportados periódicamente a vuestro comité, con la correspondiente opinión por parte del Investigador si se considera relacionado o no a droga de Estudio.
Sin otro en particular...signature etc.

Charles Davis Sep 19, 2017:

@Jane I wonder whether INDS means Investigational New Drug Safety here. That might perhaps make it a more plausible heading. There is still the either/or thing; "y" would still make more sense. But use of "o" is often different in Spanish; the sense can be closer to "and". They might mean issues that fall into the category of Investigational New Drug Safety or of Susars, if you see what I mean. The capital S would make more sense that way.

liz askew Sep 19, 2017:

Well, in English they are connected: Suspected Unexpected Serious Adverse Reaction (SUSAR)
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials.

Suspected Unexpected Serious Adverse Reaction
Suspected Unexpected Serious Adverse Reaction is the term used to refer to an adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. Reports of these reactions are subject to expedited submission to health authorities.

Perhaps you should post a paragraph in the source language!

Dr Jane Marshall (asker) Sep 19, 2017:

If it was "investigational new drugs" then the heading would be "Investigational New Drugs or SUSARs", but these 2 are not things would be grouped together like that, they are not topics that would form an "either/or" heading. Even "and" eg "INDs and SUSARs" wouldn´t really make sense would it? Had it been something like "SUSARs del IND" then yes, but phrased like this I don´t think it can be. SUSARs are something you report about an IND, they don´t form the same category (as far as I can see - please expand if you can see something I don´t!)

liz askew Sep 19, 2017:

In the context of:
Search Results
Suspected Unexpected Serious Adverse Reactions (SUSARs ...
www.proz.com › KudoZ home › English to French › Medical (general)
Jump to présomption / suspicion d'effet indésirable grave (et) inattendu - SUSAR Suspected Unexpected Serious Adverse Reaction – Suspicion de

liz askew Sep 19, 2017:

Why doesn't "Investigational New Drugs" not make sense??