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Clinical Evaluation Report Article Summary Requirements
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Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
Clinical Evaluation Report Article Summary Requirements
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  Post Number #1  
Old 17th May 2011, 01:23 AM
kkmorris

 
 
Total Posts: 3
Please Help! Clinical Evaluation Report Article Summary Requirements

Hello!

I'm new to this, have academic training in clinical studies and medical devices but no hands-on experience yet. I'm trying to get some contract work in medical writing and have been given an assignment to measure my skills. Given a relevant article by the employer I've been asked to write a 1-paragraph summary of this article. The summary needs to meet the MEDDEV 2.7.1 requirements of an article summary for a Clinical Evaluation report. Could someone out there be specific about which are these requirements? I've read the MEDDEV 2.7.1 several times but am confused about the requirements I must follow for writing up the summary.

Looking for advise. Thank you!

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  Post Number #2  
Old 17th May 2011, 03:39 AM
SteveK's Avatar
SteveK

 
 
Total Posts: 788
Lurker Re: Requirements of an article summary for a Clinical Evaluation report

This may help - go to this post where I put an attachment relating to a clinical evaluation report (in this case for a humidifier).

Clinical Evaluation for Class I Medical Devices

Steve
Thank You to SteveK for your informative Post and/or Attachment!
  Post Number #3  
Old 17th May 2011, 11:25 AM
kkmorris

 
 
Total Posts: 3
Please Help! Re: Requirements of an article summary for a Clinical Evaluation report

Hi SteveK,
Thanks for your post. I took a look at your Humidifier doc. Although it's a good illustrative example, I'm still confused as how to figure out the requirements for writing a summary of an article that will go into a clinical evaluation report. I need to write a summary from scratch and not use the abstract that comes with the article.

I've come across a post that says that this summary needs to include information about the main author of the paper. Is there anything else that needs to be addressed in the summary that is a requirement? What is your experience on this? Would anyone else also like to contribute with your own experience/knowledge?
Thanks!
  Post Number #4  
Old 17th May 2011, 11:55 AM
pkost

 
 
Total Posts: 808
Re: Requirements of an article summary for a Clinical Evaluation report

There is no requirement in the MEDDEV to write a summary about any peer reviewed article, it is entirely dependent on the the requirements of the company.

I would suggest (as you already know it is) that this is merely an exercise where you can prove yourself capable.


author - their background and experience, any conflicts of interests
device - the device being examined, how it compares to the one you are evaluating - similarities and differences
the testing - what sort of testing, in vivo/in vitro...what was the subset of patients? is it applicable to the indications for your device
Essential requirements - the essential requirements that this paper helps you to demonstrate conformance with
The results!
Conclusion - your impression as (a suitably qualified) author of the evaluation of how this supports (or not) your compliance with the essential requirements detailed earlier.
Thank You to pkost for your informative Post and/or Attachment!
  Post Number #5  
Old 17th May 2011, 04:35 PM
kkmorris

 
 
Total Posts: 3
Please Help! Re: Requirements of an article summary for a Clinical Evaluation report

Hi pkost,

Thank you for your reply. What you've stated in your post makes sense and it seems to fit what I'm expected to do. A real example would be really helpful. Would you be able to suggest where I could find some real examples of such summaries?

Thanks!
  Post Number #6  
Old 18th May 2011, 03:40 AM
pkost

 
 
Total Posts: 808
Re: Requirements of an article summary for a Clinical Evaluation report

Unfortunately because what I suggested is more of a hypothetical which would demonstrate your ability, it is not the sort of thing you would find real world examples for. You are only likely to see examples like the one posted by SteveK
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