Clinical Trial Network

Standard Operating Procedures

The ESA CTN Standard Operating Procedure is a set of written instructions that document process followed within the ESA Clinical Trial Network. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. 

SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation. 

ESA CTN SOPs are systematically reviewed every year, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. The review date is added to each SOP that has been reviewed. The finalised ESA CTN SOPs and documents are reviewed and approved by the Research Committee Chair.
Many activities use checklists, templates, detailed guidances to ensure that steps are followed in order. The attachments are not the SOP, but a part of the SOP. 

List of available ESA CTN SOPs and other Documents: