GCP for Data Management

[rdgois]

hi there,

where can one obtain more information regarings GCP in Data Management?


thanks

[M J Garbe]

Try the Association of Clinical Data Management -
They will cover the aspects of Computerised System Validation in Clinical research and requirements for Data management in Clinical Trials.
Hope this helps!

[pburns]

Hi can you be more specific about what your query is? I have contacted the GCP helpline before to ask questions about data managemnt and GCP compliance and they have been really quick in getting back. Data management is not specifically covered it seems in GCP, apart from saying it has to be GCP compliant (i.e. audit trail) etc

[CTU]

I've never found the ACDM to be useful - certainly not for academic trials. Joined and attended a couple of events and found them to be utterly pointless!

We work to this:
http://www.trialsjournal.com/content...5-12-85-s1.pdf

This is also worth a read: http://www.trialsjournal.com/content/12/1/85

If you are looking for a general data management resource to have available for new staff or for reference, Eleanor McFaddens books are good.

[Joanna Black]

There is a document entitled 'Good Data Management Practice' I think produced by ECRIN....google it and it will come up.

[smeephan]

The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.

[smeephan]

he standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff.

[a123456]

There is a document on "Good Clinical Data Management Practices" by the Society for Clinical Data Management, April 2011.

[Oglasi]

Thank you!

[a123456]

The MHRA GCP Guide (2012) has a section on data management.