230404P - QUALITY CONTROL AND RISK MANAGEMENT

Presented at a session for Clinical Research Coordinators at King Fahad Medical City Riyadh on April 10, 2023 by Dr Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Epidemiologist and bioethicist.

DUAL PURPOSE OF IRB

• The primary purpose is to ensure patient safety and welfare and prevent harm
• The secondary purpose is to ensure the validity of the data

POLICY ON PATIENT SAFETY AND QUALITY PURPOSES

• To ensure the safety of all individuals who are participating in research at KFMC.
• To establish a process for evaluating the efficacy and efficiency of the IRB at KFMC.
• To capture and provide ongoing monitoring of IRB work through the monitoring of Key Performance Indicators

HOW DO WE ENSURE PATIENT SAFETY?

• Approval of proposals in accordance with the standards
• 6-monthly progress reports
• Annual of bi-annual audits by IRB
• Regular monitoring (sometimes monthly) by the sponsor
• Immediate report and investigation of adverse event reports

DEFINITION OF AN ADVERSE EVENT

• Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's involvement in the research, whether or not considered related to participation in the research.

DEFINITION OF A SERIOUS ADVERSE EVENT

• Serious AdveBe Events (SAE): Any untoward medical occurrence, whether it is considered related to the study or not, that:
• Results in death.
• ls life-threatening, or places the participant at immediate risk of death from the event as it occurred
• Requires or prolongs hospitalization.
• Causes persistent or significant disability or incapacity.

REPORTING OF SERIOUS AE

• A severe adverse event must be reported to IRB within 24 hours
• IRB reviews AE reports immediately and takes the necessary action: suspend/stop the study, modify
• Serious adverse events must also be reported in the hospital-wide risk management database

TYPES OF ADVERSE EVENTS

• Related AE: An AE that more than likely was caused by study product or study procedures (e.9,, 'probably related" or "definitely related').
• Unexpected AE: An AE that is not identified in nature, severity, or frequency in the relevant safety documents(s) or the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study.
• Not Reportable Event: Typically, a number of events occur during the course of a study that doesn't meet reporting requirements. Examples of such events may include:

PROTOCOL DEVIATION

• Protocol Deviation/Violation: Any intentional or unintentional change from the |RB-approved protocol.
• Major protocol deviation and Minor protocol deviation
• Protocol deviations are reported to IRB
• Procedures similar to those for adverse events

DATA QUALITY

• Routine and random checks by IRB and sponsor
• A sponsor cannot take any data outside the hospital
• Data can be clinical data or management data. Management data affects clinical data

HOW DO WE ENSURE DATA VALIDITY?

• Determine the type of data to validate depending on motivation (errors, concerns, routine)
• If the study is small validate all the data entered. This is usually the case for international multicenter clinical trials because only are few patients (less than 10) are allocated to KFMC
• If the study is large we have to sample participants using some form of sample size computation
• Validation is carried out by IRB or its representative OR the sponsor (monitor or data monitoring committee)
• The process of validation involves comparing the data abstracted for the study with data in the original documents (patient charts, lab reports, etc)

REASON OF ERRORS IN DATA:

• System Errors
• Programming mistakes
• Unclear definitions of data elements
• Abstraction Guidelines - not clear or misinterpreted
• Incorrect patient matching when integrating various data sources
• Hardware failure

HUMAN ERRORS IN DATA ENTRY

• Data entry mistakes
• Missing Data entry
• Data transcription problems/Illegible handwriting
• Inaccurate data collection
• Poor training in the collection and entry of data
• Misrepresentation by patients or researchers

KEY PERFORMANCE INDICATORS (KPIs)

• Audited research projects compliance rate = percentage of projects audited in a period of time
• Research consent compliance rate = percentage of consent forms in compliance (complete, accurate, and relevant)
• Severe adverse effects reported