7 februari 2016

Kvalitetsidentifiering

Det här är områden som kan komma att diskuteras vid en förfrågan från industrin. För varje område finns också exempel på vad man kan svara.

Target question areas

Target question areas (by Industry) to check for compliance to GCP.

Qualifications for data input

Medically trained (nurses and medical doctors), trained in GCP.

Patient informed

It is documented in the registry that patient has been informed and approved to data being entered into the registry .

Patient data protection

Patients are identified by date of birth ? in the registry. The responsible authority and responsible person is XX.

Changes made in the registry

Changes is only done when an incorrect value is found or discovered. A change is “logged “and written in the registry together with the reason for change, initials and signature of the person who made the change.

Data validation

Is performed by sample check every 6 months, the sample consider of X patients. The data is checked by monitoring (by a monitor) on a regular basis or when X new patients have been entered into the registry.

Data quality

(For example diagnosis, drugs used and indications, adverse events). All data is verified in Source documents/patient records prior to data input into the quality registry.

It-systems used for the registry

The IT system used for the registry is validated, checked and controlled on a regular basis, and the checks and controls are documented. Backup of data is maintained and backup discs are archived outside of the hospital/university clinic. The server is maintained by an IT service provider and a service agreement with them is signed by the registry. Data is archived for <15 years as paper documents and electronic files?

Audit trail

Possible or not possible today to see who did what and when.

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