QUALITY ASSURANCE IN CLINICAL TRIALS

 

INTRODUCTION

Quality assurance (QA) defines and maintains specifications to develop and produce reliable products. QA is the process that helps the sponsor and investigator to monitor and evaluate the protocol process and its implementation

Quality assurance includes two principles:

  • Fit for the purpose (product should be suitable for the intended purpose)

  • The right first time (mistakes should be eliminated)

Importance of Quality assurance

Quality assurance in clinical trials is a set of internationally recognized scientifically ethical quality requirements observed and used in designing, conducting, recording, documenting, and reporting clinical trials involving human subjects' participation.


QUALITY ASSURANCE ACTIVITIES IN CLINICAL TRIALS

  • Addresses system issues before the end of the trial

  • Come up with ways to minimize cycle times for various processes

  • Helps minimize data queries

  • Make sure that the data entered at all stages of the trial is consistent and accurate

  • Ensure that it complies with protocols, standard operating procedures, and good clinical practices

  • Play an important role in dealing with cases of error during the trial

The ISO definition states that quality assurance is all those planned and systematic actions that are to be established to ensure that the trial is performed and the data are generated, documented, and reported according to protocol, Standard Operating Procedures (SOPs), and good clinical practices (GCPs).


IMPORTANCE OF QUALITY IN CLINICAL TRIALS

  • Quality assurance in a clinical trial can reduce the possibility of difference and allow systemic treatment management among participating institutions.

  • Quality assurance practitioners in clinical trials are also responsible for incorporating protocol-compliant topics for the project.

  • The clinical research quality assurance audit team verifies from initial data collection to the final trial report.

  • Audits help the team member to analysis the entire clinical trial process which includes the following:

  1. Identify and rectify issues

  2. Modify and improvise the process for future trials


HOW TO ENSURE QUALITY ASSURANCE?

The important aspects that require in ensuring quality assurance are the following:

  1. Sponsor Monitoring

  2. Self-monitoring

  3. Self-checks

  4. Standard tools

  5. Written procedures


ROLE AND RESPONSIBILITIES OF QUALITY ASSURANCE IN CLINICAL TRIALS

Quality assurance professionals standardly have the following responsibilities:

  • Manage and maintain data sources for the quality system

  • Review quality activities, errors, concerns, and problems

  • Prepare reports for submission to regulatory authorities

  • Record internal regulatory procedures

  • Maintain contemporary with total relevant quality regulations and compliance concerns

  • Prepare standard operating procedures


QUALITY- NEW REGULATORY APPROACHES AND INITIATIVES

Regulatory authority review of quality issues in trials is compelling them to consider new approaches to assess the quality of clinical trial conduct. The FDA is developing new approaches to risk-based inspection which include:

  • Bioequivalence inspection model

  • IRB inspection model

  • Sponsor or CRO surveillance inspection model

  • Center for Drug Evaluation and Research (CDER) 

     risk-based site selection tool


MONITORING PROCESS

The process of monitoring includes four major steps which include:

1. Site initiation visit
2. Centralized monitoring
3. Periodic site monitoring
4. Close out

RISK

The more frequent risks are followed in systematic problems, Protocol design, and Departmental problems.

  1. Root cause: The root cause is the initiating, most basic cause of a problem that may or may not lead to a chain of causes or other problems. Eliminating the root cause should prevent the recurrence of the problem.

  2. Root Cause Analysis (RCA): It is the process of identifying the root cause and the downstream effect on the causal chain.

  3. Corrective and Preventive Actions (CAPA): 

  • Corrective Action is the process of reacting to an existing problem and fixing it.
  • Preventive Action is the process of detecting potential problems and eliminating them.


  1. Effectiveness check: It verifies that the CAPAs resolve the root cause. This is the final step of CAPA

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