SOPs should be detailed enough so that a procedure can be correctly carried out in a reproducible manner, but not so specific that they can only be applied to one project and then have to be rewritten for the next. It is almost always necessary to adapt SOPs to an individual department, and the SOPs here can be tailored to suit your needs,as long as the requirements of GCP are maintained.
The SOPs here can be broadly divided into the following sections:
- General study organisation
- Pre-study
- During study
- End of study
Great Article. One issue faced by sites is it often very hardto balance between keeping up with the GCP regulations and making out of the box Standard Operating Procedures for Clinical Research customizable enough to make them site specific.
ReplyDeleteThanks jwilkerson. I totally agree with you :)
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