CFR 21 part 11 and its application on computerised systems used in clinical trials , clinical studies , clinical investigations.
There is an increasing use of computerized systems in clinical trials to generate and maintain
source data and source documentation on each clinical trial subject. Such electronic source data and source documentation must meet the same fundamental elements of data quality (e.g.,attributable, legible, contemporaneous, original and accurate) that are expected of paper records and must comply with all applicable statutory and regulatory requirements. FDA’s acceptance of data from clinical trials for decision-making purposes depends on US FDA’s ability to verify the quality and integrity of the data during US FDA’S on-site inspections and audits. (21 CFR 312, 511.1(b), and 812).
21 CFR part 11 was issued in march 1997 which provides criteria for acceptance by US FDA,under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
After the effective date of 21 CFR part 11, significant concerns regarding the interpretation and implementation of part 11 were raised by both US FDA and Industry. As a result, US FDA had decided to reexamine 21 CFR part 11 with the possibility of proposing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements in the interim.
In May 2007 US FDA issued a guidance to address above issue , ie. Computerized Systems Used in Clinical Investigations , the recommendations made by US FDA are not legally enforceable but is the current thinking of US FDA and one should learn through this about how to implement 21 cfr part 11 in computerized systems used in clinical trials , clinical studies , clinical investigations .
It has given recommendations to sponsors of clinical trial , clinical study , contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), regarding the use of computerized systems in clinical investigations. The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA. Because the source data are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs and medical devices,
Standard Operating Procedures with respect to CFR 21 PART 11.
There should be specific procedures and controls in place when using computerized systems to create, modify, maintain, or transmit electronic records, including when collecting source data at clinical trial sites. A list of recommended standard operating procedures (SOPs) is provided in such SOPs should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records, and the SOPs should be made available for use by personnel and for inspection by FDA.
Standard operating procedures (SOPs) and documentation pertinent to the use of a computerized
system should be made available for use by appropriate study personnel at the clinical site or
remotely and for inspection by FDA. The SOPs should include, but are not limited to, the
LIST OF STANDARD OPERATING PROCEDURES FOR 21 CFR PART 11 COMPLIANCE IN CLINICAL TRAIL INVESTIAGTONS. (IT MAY BE BIGGER LIST AS REQUIRED BY INDIVIDUAL ORGANISATION)
*System setup/installation (including the description and specific use of software,
hardware, and physical environment and the relationship)
*System operating manual
*Validation and functionality testing
*Data collection and handling (including data archiving, audit trails, and risk assessment)
*System maintenance (including system decommissioning)
*System security measures
*Data backup, recovery, and contingency plans
*Alternative recording methods (in the case of system unavailability)
*Computer user training
*Roles and responsibilities of sponsors, clinical sites and other parties with respect to the
use of computerized systems in the clinical trials
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