Quality management

 Good Clinical Practices (GCP) form the international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides assurance that the rights, safety and well- being of trial subjects are protected and are consistent with the principles that have their origin in the Declaration of Helsinki and that trial data are credible.

Hence to achieve these standards and maintain credibility of the data generated in clinical research it is essential to implement and maintain quality assurance and quality control systems.

The Quality Assurance System focuses on the following aspects.

  •  Quality Assurance of clinical studies:
    • This   involves monitoring and periodic auditing of clinical studies. Internal monitoring is undertaken for clinical studies initiated at CRF to verify the quality of data generated by the study. Internal Audits are conducted periodically to assess and assure the reliability and integrity of a trial’s quality control systems and measure the performance against quality standards. An internal audit plan is developed to ensure that trial related activities are performed as per the SOPs and standard guidelines.
  • Developing, implementing and upholding standard operating procedures
    • SOP is a formal document that describes in detail written instructions to achieve uniformity of the performance of a specific function. The SOPs are made /reviewed and implementation ensured for the following systems:

    •  Clinical trials:

      • Pulmonary function Laboratory
      • Bio-Analytical laboratory
      • Pharmacy
      • Serious Adverse Event management system
      • Imparting training In GCP/relevant regulatory guidelines
  • Training :
    •  Training is an integral part of developing a quality assurance system. The trial staff is trained in Good Clinical Practices, Clinical trial operations and SOPs to be implemented. We also conduct training programs in GCP for Investigators and clinical research professionals to share and disseminate our experiences and knowledge gained by conducting clinical trial over past few years. Appropriate planning before the trial, adequate oversight and monitoring during the trial, and verification to ensure accurate reporting of results at the conclusion of the trial, create a framework for assuring quality in clinical studies. 
CRF at ERS 2016 London
7 of the 12 abstracts submitted were selected at t
CRF at ERS 2015 Amsterdam
9 of the 13 abstracts submitted were selected at t
Chest Research Foundation, Pun...
Programs management
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