ICH Good Clinical Practice defines quality assurance as all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and recorded in compliance with Good Clinical Practice and applicable regulatory requirements. (ICH GCP 1.46) Within the quality assurance system, several operational techniques and activities help to verify that the requirements for quality of trial related activities have been fulfilled. (ICH GCP 1.47)
Industry sponsored clinical trials usually have a comprehensive monitoring plan. Regular monitoring of a trial is very helpful to verify compliance of the trial with currently approved protocol, Good Clinical Practice and applicable regulatory requirements.
Ideally, every clinical trial should have a monitoring plan for quality management. The extent and nature of monitoring may be determined based on various considerations such as trial design, complexity, size, risks to subjects, and endpoints of the trial
The Clinical Trials Resource Center would be happy to work with researchers to develop a suitable quality management plan for investigator initiated clinical trials. Some of the tools that are used in quality checks are listed below:
Source Data is defined as all information in original records or certified copies of clinical findings, observations, or other activities that are necessary for reconstruction and evaluation of the trial. The records that contain source data are called Source Documents. Source Document Verification is an important part of monitoring. Source data is verified by reviewing all the data variables in the case report form accurately reflect information in the source documents.
The extent of source document verification is based on several factors such as complexity of the trial, risks for subjects, phase of the study, number of subjects enrolled etc. Researchers may choose any option that is appropriate for the trial, some of the options include; a review of all data variables in the case report form for all enrolled subjects, a review of all CRF data for a percentage (e.g. 5%) of patients enrolled or even a review of only certain specified variables on all or some CRFs (for example, only the eligibility criteria).
Use the Chart Audit Tool adapted from DMID, for source document verification for your clinical trial. Here is a sample DMID Quality Management Plan for reference.
Essential Documents permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing these documents in a timely manner can greatly assist in the successful management of a trial.
Use the Regulatory File Review Tool that is adapted from DMID to check your Regulatory Binder for quality.
last modified October, 2013
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