Tools to help you carry out  your research.

Topics:

Logs  |  Standard Operating Procedures (SOPs)  |  Investigational Medicinal Product (IMP)

Monitoring  |  Samples

Logs

Template logs including delegation logs and training logs.

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Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) should be developed for all aspects of study conduct and management in order to ensure that studies are conducted and data generated, recorded and reported in compliance with the protocol, the principles of GCP and applicable regulatory requirements. SOPs should be a set of clear and concise written instructions, designed to ensure that performance of an activity is standardardised, regardless of who is carrying it out.

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Investigational Medicinal Product (IMP)

Template SOPs associated with an Investigational Medicinal Product (IMP), and include the receiving of, and disposal of an IMP, and temperature recording. 

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Monitoring

Monitoring involves overseeing the progress of the study in order to confirm that:

  • the rights and well-being of participants are protected
  • the data are accurate, complete and verifiable from source documents, where the source document is
  • not the CRF itself
  • the study is conducted in compliance with the current approved protocol, SOPs, the principles of GCP
  • and regulatory requirements

The extent and nature of monitoring should be proportionate to the risks to participants, the organisation and/or data quality and results, as determined in the risk assessment carried out at the planning stage.

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Samples

Template SOPs for managing biologicaland blood samples.

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