Guideline
Purpose and use of this guideline document
On occasion adverse events will occur within laboratories performing clinical trial sample analysis or evaluation to GCP standards. Examples of adverse events which may occur include:
¨ Equipment failure or equipment calibration check failure.
¨ Deviations in contractual agreements.
¨ Unplanned SOP or protocol deviations.
¨ Breaches in patient confidentiality.
¨ Computer software failure.
¨ Security breaches.
¨ Spillage or contamination.
¨ Accidents, flood or fire.
This purpose of this document is to provide guidelines for the development of procedures which ensure effective and timely communication of laboratory adverse events and their impact so that the significance and impact on the safety and wellbeing of the trial subjects and on the integrity and reliability of the trial data can be assessed.
Crucially, any adverse event which may represent a Serious Breach of GCP must be reported immediately so that the MHRA and the Research Ethics Committee can be notified.
Scope of this guideline document
The QCD should be used to develop procedures following every laboratory adverse event.
However separate guideline documents and example forms are available to help develop additional procedures following specific incidents:
¨ Equipment failure or equipment calibration failure (UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checklist, UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure, UoB-CLN-LAB-QCD-021 Equipment maintenance record and UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration failure report).
¨ Analytical assay failure (UoB-CLN-LAB-QCD-009 Analytical assay failure and UoB-CLN-LAB-QCD-028 Analytical failure report).
¨ Procedures following failure of a storage unit (UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit).
Record keeping
¨ Adverse events should always be documented and any impact on patient safety, sample and data integrity should be assessed, recorded and reported appropriately. Corrective and preventative action(s) should be instigated where appropriate and documented. An example form is available (see UoB-CLN-LAB-QCD-032 Adverse Event report).
¨ All records must be stored safely and securely throughout the trial and archived with the other trial documents when the trial closes.
Developing written procedures
You are strongly advised to develop trial-specific written procedures for adverse events and should include:
¨ The name or job title of the person(s) responsible for reporting and documenting adverse events, for instigating corrective and preventative actions, with clear reporting lines.
¨ Procedures developed from the guidelines below.
Guidelines
¨ Document the nature of the adverse event (for example form see UoB-CLN-LAB-QCD-032 Adverse Event report).
¨ In addition:
o For equipment failure or equipment calibration failure refer to UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checklist, UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure, UoB-CLN-LAB-QCD-021 Equipment maintenance record and UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration failure report.
o For analytical assay failure refer to UoB-CLN-LAB-QCD-009 Analytical assay failure and UoB-CLN-LAB-QCD-028 Analytical failure report.
o For failure of a storage unit refer to UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit.
¨ Consider (in collaboration with others if necessary) and document the impact of the adverse event on the following:
o Patient consent and confidentiality
o Data integrity
o Sample integrity
o Data security
o Health and Safety
¨ In collaboration with others where necessary, decide whether the adverse event could constitute a Serious Breach of GCP.
¨ If it the adverse event is not considered to be a Serious Breach of GCP then consider whether and corrective and preventative actions are appropriate. If so, then document and implement these.
¨ If it the adverse event is considered to be a Serious Breach of GCP then inform the Principal Investigator and Sponsor (or representative e.g. CRCT) immediately.
¨ The Sponsor (or representative) must notify the MHRA and the REC about the Serious Breach and any urgent safety measures.
Related documents
¨ UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory¨ UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checks
¨ UoB-CLN-LAB-QCD-009 Analytical assay failure
¨ UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure
¨ UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit
¨ UoB-CLN-LAB-QCD-021 Equipment maintenance record
¨ UoB-CLN-LAB-QCD-028 Analytical failure report
¨ UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration failure report
¨ UoB-CLN-LAB-QCD-032 Adverse event report
UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory v1.0 (EAv1.0) / Page 2 of 2