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Quality Assurance in clinical research

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					QUALITY ASSURANCE IN CLINICAL RESEARCH

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Terminologies Definition of QA Difference between QA&QC Quality challenge Quality plan QA activities Data management QA Statistical analysis QA Tools for assessing QA & QC Audit Types of audit Inspection Responsibilities of QA personnel Conclusion Reference

TERMINOLOGIES
QUALITY The total set of characteristics of a product or service that affects its ability to satisfy a customer’s stated or implied needs.
Quality in clinical research may be defined as: • Reliability and credibility of information providing an answer to a scientific question. • Compliance of trial process with defined requirements.

QUALITY SYSTEM: It is the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. A quality system starts with QA.

QUALITY MANAGEMENT: It is the system to ensure that the product or service meets or exceeds the customer’s expectation.

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QUALITY MANAGEMENT SYSTEM : A set of interacting elements established to direct and control an organization with regards to quality. QMS is a tool to establish and continuously and consistently achieve quality objectives based on customer’s requirements. QUALITY CONTROL (QC) : It is defined as the periodic operational checks within each functional department to verify that clinical data are generated, collected, handled, analyzed and reported according to protocol, SOPs and GCP.

QUALITY ASSURANCE (QA):
All those planned and systematic actions that are established to ensure that trial is performed and data are generated, documented, and recorded in compliance with good clinical practice and applicable regulatory requirements.

DIFFERENCE BETWEEN QA & QC

QA
A set of activities to ensure that the development &/or maintenance process is adequate to ensure a system will meet its objectives. • QA is process oriented. • QA should be carried out by an independent person/team. • QA makes sure that you are doing the right thing, the right way.
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QC
A set of activities designed to evaluate a developed work product.
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QC is product oriented. • QC can be carried out by functional personnel.
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QC makes sure that the results of what you have done is what you had expected.
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QUALITY CHALLENGE
Through out the trial, it is necessary to continually monitor data collection procedures and data management practices to maintain the QUALITY of data. This includes ●

Ensuring that data generated during study reflect what is specified in the protocol (CRF v/s protocol). Comparing data in CRF and data collected in source documents (CRF v/s source documents). Ensuring that data analyze are the data recorded in CRF (database v/s CRF).

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QUALITY PLAN
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Quality plan describes how the QA & QC processes will be applied throughout the clinical trial. A quality plan documents specific quality practices, resources & activities relevant to a specific project. This includes both operational QC & QA activities.

QA ACTIVITIES
The QA activities to be conducted during a specific clinical trial are included in the audit plan. These activities includeThe number of investigators site, selection criteria and the vendors to be audited such as labs & drug packaging & distribution providers. Specifies what internal processes of the study will be audited from initial study design, site & data management, statistical analysis & final CSR. Specifies audit team members and auditees for each study stage as well as the standards against which the audit will be conducted.

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COMPLIANCE TO GLP

COMPLIANCE TO GCP

COMPLIANCE TO OTHER REGULATORY AUTHOTITIES

QUALITY ASSURANCE

COMPLIANCE TO STUDY PROTOCOL

COMPLIANCE TO SOP

DATA MANAGEMENT QA
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Data entry & database QC process are critical areas of data management process that are audited by QA personnel.
Audits review the documented evidence that show data accuracy & integrity were verified & checked manually, independently to ensure that the data is logical.

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STATISTICAL ANALYSIS QA

QA of statistical analysis process ensures Statistical Analysis System (SAS) programs are validated for generation of all tables, graphs by checking that all requirements were met & boundary conditions were tested.

TOOLS FOR ASSESSING QA & QC
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AUDIT

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INSPECTION

AUDIT
Audit refers to an independent examination of trial related activities & documents so as to determine whether or not the trial related activities are conducted in accordance with the study protocol, relevant SOPs, GCP & applicable regulatory requirements.
The ultimate purpose is to ensure the quality, integrity & validity of investigational data.

TYPES OF AUDITS
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2. 3.

4.
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Sponsor audit of investigative site IRB audit of investigative site System audit of sponsor/CROs Clinical laboratory audit Clinical study report audit Validation of computer system

INSPECTION
The act by regulatory authority(ies) of conducting an official review of documents, facility records & any other resources that are deemed by the authorities to be related to clinical trial & that may be located at the site of the trial, at the sponsor’s &/or CROs facilities or at other establishments deemed appropriate by the regulatory authority(ies).

Contd…
The inspection program determines :
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The degree to which sponsors, monitors, clinical investigators, site staff, IRBs & CROs have fulfilled their trial related obligations.

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The acceptability of resultant clinical data in support of a new drug, biologic or devices approval.

RESPONSIBILITES OF QA PERSONNEL
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Maintain all approved protocol & SOPs Verify protocol Conduct audits – study based, facility, processed (record to be retained ) Audit records & final reports Training organizational personnel in regulatory requirements Prepare & design QA statement Maintaining record of QA

CONCLUSION
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Provides assurance to management and others involved in a trial process that CR activities have resulted in work of highest quality. Ensures management of compliance with protocol, SOPs and GCP. Ensure systemic problems to be resolved before end of the study. Helps reduce data queries as well as identify ways to reduce cycle time for various processes.

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Contd…
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Ensures data continuity throughout the course of study, that the data collected are the data required by the protocol. Ensures the accuracy and the consistency of data, from source document entry into CRF to final data bases reported in final CSR.

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Evaluates all QA functions in effort to continually improve QA methodologies.

REFERENCES
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www.pharmanet.com
www.actmagazine.com Basic principles of clinical research and methodology – S.K. Gupta.

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