Your Easy Guide to Clinical Studies

Working instructions (WIs) are documents that clearly and precisely describe how to perform a particular task. Their application are especially important in tasks where deviations can result in some undesirable consequence or even damage.

 

WIs:

• Are hand-on instructions, frequently needed during daily work (e.g. instructions on blood sampling and processing, how to conduct a study visit)
• Are flexible, able to easily adapt to changing circumstances and requirements. As a consequence WIs:
  • Are reviewed on a regular basis
  • Have a simplified review and release process (e.g. compared to SOPs)
• Ensure performance of study tasks are harmonised as well comparable between participating study sites

 

Apart from SOPs and WIs, other useful study documents exist such as templates, logs, checklists and forms. All these documents have important supportive character that give guidance to study staff involved in various responsibilities.

As a SP-INV:

• Develop WIs applicable to your study:
  • Include test phases to ensure WIs correctly mirror process steps (e.g. especially important for the documentation of complex processes)
  • Ensure WIs are user friendly (e.g. validated in a test phase)
  • Write preferably in a local language to avoid misunderstandings
• Provide Site-INV(s) with study relevant WIs
• Incorporate WIs in the study DMS
• During study conduct, request feedback regarding inconsistencies including performance difficulties
• Implement WI adaptations as soon as they become known

 

As a Site-INV:

• Train study staff on the SP-INV provided WIs
• Ensure the SP-INV pre-approves locally devised WIs
• Implement local WI adaptations as soon as they become known, and inform the SP-INV

 

Study staff:

• Provide feedback on implemented WIs regarding inconsistencies, impossibilities and errors

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