miércoles, 9 de junio de 2010

Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files


For those high volume submitters using a gateway to gateway connection using AS2 or thinking of using a high volume solution in the future, you might find this e-mail of interest. The Implementation Specification found in the Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) files has been updated with some important information. Rather than you having to rummage around in the file to see the additions, I thought I would list them here:

1) Under the section titled “How do I know my submission reached CDRH?” where the 3 acknowledgements sent via the ESG are discussed, I added the following:

“For those reporters using a B2B account (i.e. a gateway to gateway connection) using AS2, you should not rely on the "Content-Type" header for determining how the acknowledgments are processed. Acknowledgements should be processed based on the file extension and actual content, and your systems should be programmed accordingly.”

This was added to address the issue where the content type sent by the Electronic Submissions Gateway (ESG) in test and production differ.

2) Under the section titled “Can I submit attachments?” I added this simple instruction:
“Please limit each attachment to 50 MB in size.”

Anything larger might cause our loading programs to stall.

3) I added a new question/answer in the FAQ section:

“Electronically submitted adverse event reports do not have all the fields found in the 3500A form able to be mapped. How should we send information that is not able to be mapped to a 3500A field?

Correct. Some fields such as G5’s check boxes for combination product, pre-1938, and OTC product are not available for mapping. If you would like to indicate this information or any information that is not mapped, please use section H10 (manufacture narrative) to indicate this information.”

Many reporters already have noticed this, but it's good to have it noted in the implementation file.

I also went through the document to correct all the website links to make sure they all pointed to the information they described. All in all, some nice information added to the spec and good to be aware of.
Eugene Reilly

open here please:
Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files

No hay comentarios: