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SGW on Monitoring of LMOs Released into the Environment

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Item 3: The General Structure [#2596]
Item 3: The General Structure

Question: Keeping in mind the objective of our guidance to provide useful, clear advice to less experienced users, or those without articulated provisions within their domestic biosafety legislation—Do you feel that the general structure of the document helps meet these goals? If not, what suggestions do you have for improvement?
posted on 2011-08-11 20:05 UTC by David Quist
RE: Item 3: The General Structure (reply of Hans Bergmans) [#2609]
The structure of the document is, broadly speaking, in line with the structure of our previous guidance documents.
What I would ask the author to do is to look very closely whether all issues treated in the different sections of the document as it is now, are really in their correct place and are necessary in that place.
The introduction, for instance goes already into quite a lot of detail of the monitoring process.
This may help to get rid of a number of repeats and redundancies in the document.
The text is generally verbose and due to this, not straightforward.

A straightforward structure of the document would be:
Start the text with clear statements what the Protocol says about monitoring.
Based on that, what is this document talking about: what type(s) of monitoring, what is CSM and what is GS.
Then, as the bulk of the document, a description of CSM and GS, as separate issues but clearly related issues.
You end with some further considerations, that can probably be best appreciated at the end of the document: things like how does monitoring fit into the decision making process, and who is to pay for monitoring
posted on 2011-08-18 15:09 UTC by Mr. Hans Bergmans, PRRI
RE: Item 3: The General Structure (reply of Hans Bergmans) [#2622]
I see the following sections:
- Introduction (Background should be incorporated into Introduction; no Preface)
- Objective and Scope (short)
- General principles of monitoring (very short)
- Types of PMEM strategies (this is the main part of the document)
             - CSM
             - GS

- Use of monitoring results

I think the document should be concise and use clear language; the document is currently verbose and repetitive
posted on 2011-08-18 21:48 UTC by Ms. Esmeralda Prat, CLI representation
RE: Item 3: The General Structure [#2633]
I think the structure suggested by Hans and Esmeralda is fine, and in general I would keep the language much shorter and simpler. See also my comments and track change with the first draft 

Piet
posted on 2011-08-18 22:21 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Item 3: The General Structure [#2644]
A structure like the one Hans and Esmeralda are proposing would be fine.
Introduction: Short with a clear statement on what the Protocol says about monitoring and a definition of what is monitoring in the context of the guidance.
Objective and Scope of the guidance: mainly the propose of the guidance and how it covers it propose.
Types of PMEM strategies (this is the main part of the document)
             - CSM Here the monitoring plan
             - GS
Use of monitoring results and how it relates to the RA and the decision making process.
posted on 2011-08-19 04:29 UTC by Ms. Sol Ortiz García, Mexico