05/10/2006

Consultation on draft guidance for non-commercial clinical trials

DG Enterprise and Industry has released ‘Draft guidance on ‘specific modalities’ for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice’.

This guidance includes information regarding the definition of non-commercial clinical trials and the specific modalities, labelling and documentation, concerning the investigational medicinal product.

DG Enterprise and Industry has also been considering the issue of the monitoring of non-commercial clinical trials. However, specific modalities on monitoring have not been included in this draft guidance since they would go beyond the provisions of Directive 2005/28/EC.

Nevertheless, if stakeholders want to make comments or proposals in relation to the monitoring of non-commercial clinical trials, they are welcome to do so in the framework of this consultation.

More information here
Share |

Latest publications

Banner

Vienna seminar and symposium presentations

You may now view your favorite presentations from the 16th Congress of the EAHP as the audio and video presentations are now available online. To view, please click on the dvd above. You may also order the cd/dvd by emailing sec (@) eahp.eu.

eZ debug

Clear cache:

Quick settings:

Notice: eZMySQLDB::query(0.000 ms) query number per page:0 May 23 2012 05:46:38
SET NAMES 'utf8'
Timing: May 23 2012 05:46:38
Module start 'content'
Timing: May 23 2012 05:46:38
Module end 'content'
Timing: May 23 2012 05:46:38
End

Timing points:

CheckpointElapsedRel. ElapsedMemoryRel. Memory
Module start 'content'0.0000 sec0.1068 sec4,348.5977KB2,196.2344KB
Module end 'content'0.1068 sec0.5345 sec6,544.8320KB4,943.6211KB
End0.6414 sec 11,488.4531KB0.0000KB
Total runtime:0.6513 sec

Time accumulators:

 Accumulator Elapsed Percent Count Average
ini_load
Load cache0.0329 sec4.4915%120.0027 sec
FindInputFiles0.0260 sec3.5482%120.0022 sec
Mysql Total
Mysql_queries0.0153 sec2.0872%1570.0001 sec
Looping result0.0107 sec1.4646%1550.0001 sec
Template Total0.5375 sec 73.3% 2 0.2688 sec
Template load0.0217 sec2.9631%20.0109 sec
Template processing0.5156 sec70.2889%20.2578 sec
override
Cache load0.0122 sec1.6647%20.0061 sec
General
String conversion0.0000 sec0.0027%10.0000 sec
dbfile0.0613 sec8.3572%50.0123 sec
Total script time:0.7335 sec

Templates used to render the page:

Usage countRequested templateTemplateTemplate loadedEditOverride
1pagelayout.tpl<No override>design/eahp2/templates/pagelayout.tplEdit templateOverride template
1setup/debug_toolbar.tpl<No override>design/sydesy/templates/setup/debug_toolbar.tplEdit templateOverride template
      
 Number of times templates used: 2
 Number of unique templates used: 2
 Time used to render template usage: 0.0001 secs