Quality Management Tool

Quality Management Tool Checklist

Staff

• Staff have the appropriate training required to work on the study (including site SOPs, protocol, GCP and any others) and that this is up to date, documented and filed

• The delegation log is up to date and has been signed by the PI

• Staff and PIs CVs are up to date

• Current copies of the medical licence of investigators are available

• If required, financial disclosure forms have been completed and filed

Investigator Site File

• Current versions of study documents (e.g. protocol and ICF) are being used

• Older versions of documents have been filed and marked as superseded

• SAE reports are available and filed, if applicable

• If applicable, the protocol deviation log is available and up to date

• Relevant meeting minutes have been filed

• Regulatory approvals and correspondence are complete and filed

• The Investigator brochure (IB), safety letters and protocol are available and acknowledged (signed for) by investigator

• Monitor correspondence and monitoring visit follow-up letters are filed

Subject Files

• Case Report Forms (CRFs) have been completed correctly and in a timely manner

• Source documents are available for all subjects

• All original versions of current and previous Informed Consent forms are accounted for and executed correctly

Site Documents

• SOPs are available, latest version is being used, SOP training is acknowledged by staff if applicable

• Equipment and emergency trolley/cart control logs are available

• Valid calibration certificates for all equipment are available

• IP Temperature logs are complete, and all IP accountability documents are available & All IP receipts are available