Module 5 Presentations

Source/CRF Data

• Source data not recorded to GCP (i.e. errors not scored through appropriately or not initialled and dated). • Unable to verify source data. • AE/SAE not transcribed from the source data to the CRF. • Incorrect/missing data in CRF (e.g. concomitant medication/ treatment, ratings/VAS scores etc.). • Duplication of entries all identified as the source data, but inconsistencies identified (e.g. same assessments recorded in the patient notes, trial source workbook and CRF, all different and unclear where assessment was written first).

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Clinical Sample Management

• No documentation to verify the chain of custody (i.e. the transfer of samples between site and central laboratory). • Unable to ensure when samples were shipped or received and maintained at the correct temperature during transit. • There were no records to verify that samples had been processed according to the protocol (i.e. that centrifuging requirements such as speed, time and temperature were adhered to). • There were no records for the storage location and freezer temperatures where the laboratory samples were stored. • Sample logs did not provide enough details to verify exactly what samples were stored/shipped/received as they only contained a total, rather than an exact breakdown of samples per participant /time point.

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