Your Easy Guide to Clinical Studies

All collected study data must eventually be entered into the eCRF of the study. How data is collected (e.g. pCRF, laboratory print outs, participant questionnaire) or structured (number of visits, type of variables) depends on the study design.

 

Each participant and event (e.g. study visit) is given a unique identifier. This is important to:

• Maintain participant confidentiality
• Ensure any collected data is correctly allocated to the respective participant and applicable study visit
• Link all study documents and data to the same participant
• Build a data-set with variables that can be used for statistical analysis and the generation of study results

 

Database set-up or structure can include aspects such as:

• The definition of a pre-defined number of study visits
• Randomisation where participants are allotted to different groups
• Blinded interventions where randomised groups are not-identifiable
• Standardised code libraries (e.g. ATC or MedDRA coding)

As a SP-INV or Site-INV:

• Delegate data collection and entry responsibilities to qualified staff
• Ensure staff is properly trained and have ongoing access to the eCRF of the study (e.g. individual access)
• Ensure a study DMan is available for questions or support (e.g. updates, system failure)
• Review the data entered in the eCRF to confirm its accuracy
• Delegate data verification to an independent and qualified monitor

 

Any data analysis performed by the SP-INV during study conduct can only be implemented based on specifications given in the study protocol (e.g. planned interim analysis).

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References

ICH GCP E6(R2) – see in particular guidelines

• 5.5. Trial Management, data handling, and record-keeping