Ensuring Clinical Trials Comply with Good Documentation Practice (GDP) Guidelines

Good Documentation Practices (GDP) are essential for ensuring compliance with current Good Manufacturing Practice (cGMP) standards and for organizations that implement a controlled document system. GDP is critical for maintaining data integrity and security, as well as passing cGMP audits. It is also important for accurately recording the progress of a clinical trial subject from consent to completion of the study. To ensure that clinical trials are conducted in accordance with GDP guidelines, organizations should understand the principles of GDP, have a clear understanding of the requirements of cGMP standards, and provide adequate training and experience to those responsible for completing controlled documents. Good clinical practices (BCP) are a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, registering and reporting clinical trials involving human beings.

These standards include documenting the responsibility of the product under investigation, recording the responsibility of the investigational product dispensed, consumed and returned by the subject, and serving as a reference for the treating physician at any time. Documentation deficiencies may be due to a lack of training and experience to fully understand documentation and clinical research requirements. Organizations should ensure that all information contained in the original records and in certified copies of the original records about clinical findings, observations, or other activities of a clinical trial necessary for the reconstruction and evaluation of the trial is documented. This includes having a control system in place to assess risks, batch tracking, audits and recall procedures. It is also important to provide adequate training to those responsible for completing controlled documents. In India, documentation of standard medical practice may not be as extensive as you would expect from clinical research.

Therefore, organizations should ensure that all personnel involved in clinical trials have a clear understanding of GDP guidelines and cGMP standards. This will help ensure that all documentation is completed accurately and in accordance with these regulations.

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