ABSTRACT
In a clinical trial registry, one determines whether a trial is registered prospectively or retrospectively by comparing the date of registration with the date on which enrollment started. However, in Clinical Trials Registry – India (CTRI), in addition, the top of each record is labelled with the phrase “Trial Registered Prospectively” or “Trial Registered Retrospectively”. In examining CTRI records, we have found that (a) although retrospective registration has been disallowed from April 1, 2018, some trials were registered retrospectively; (b) in some cases, enrollment started after registration, even though they were labelled “Trial Registered Retrospectively”, which is misleading; and (c) in some cases, the date of first enrollment was modified, changing a retrospective registration to a prospective one, although the label “Trial Registered Retrospectively” persisted. This, too, is misleading. The CTRI administration should take suitable steps to prevent late registration and mislabelling of trials regarding their registration status.
ABSTRACT
Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.
ABSTRACT
Most of the prior studies concentrated on warning letters issued for clinical investigation, Institutional review board,and infringement of promotional claims, no studies assessed the warning letters issued for infringements of CurrentGood Manufacturing Practice (cGMP) pertaining to medical devices. Hence, there is a need to carry out a crosssectional study of these warning letters. Publically available U.S. Food & Drug Administration (USFDA) letters underthe law of the freedom of Information Act sent to the pharmaceutical company were accessed from the USFDA website.A standard data collection tool (Excel Spreadsheet) with all letters of warning issued from January 2008 to July 2018was developed. Letters have been manually screened. Warning letters related to medical device breaches of cGMPwere screened based on the letter's subject and content. Overall, 669 warning letters issued for medical device cGMPviolations were reviewed between January 2008 and November 2018. From 2008 to 2013, there was a downward trendin the issuance of warning letters. The number of warning letters issued in 2014 was 101, followed by 106 in 2015,as the USFDA focused more on data integrity issues, while the number decreased to 53, 27, and 19, respectively, in2016, 2017, and 2018. The highest number of warning letters were issued to manufacturers located in the USA (379),followed by Canada (52), and China (37). Section 820.30 of Title 21 CFR was found to be most violated with 603infringements. This section represents the design control requirements for cGMP. Class 2 type of medical devices werefound to be most violated (82%), followed by Class 3 with 7%. Only 32% of the companies responded to the warningletters although 52% Not Issued the closeout letter followed by 16% of the letters were considered as non-applicableletters. With the time, scientific developments and increased awareness of both regulatory authorities and industries/academic organizations, overall improvement are observed with significant decrease in the number of warning letters.
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OBJECTIVE: To understand the new development of data integrity by drug regulatory agencies. METHODS: Data integrity by drug regulatory agencies in domestic and abroad were interprated in this paper. Data integrity is critical elements of the pharmaceutical quality system, and drug regulatory agencies have issued practise /guidance on data integrity to highlight it. Practise /guidance provide a basic overview of key principles relating to data management and integrity which are regularly updated, revised and reviewed based on the feedback from review agencies, including the experience provided by various regulatory agencies and enterprises. RESULTS: and CONCLUSION: This paper summarizes the individual and common issues of the six major data integrity practise /guidance, explains and differentiates some concepts, which helps to understand and apply practise /guidance.
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OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.
ABSTRACT
Many computer systems can be used in the diagnosis and care of subjects in a clinical study,in dispensing drug supplies,and in performing laboratory tests required by the study protocol.It is important that these systems are closely controlled and perform reliably every time they are used.International regulations require that such systems be well documented.Audits and inspections at clinical study sites under Good Clinical Practice(GCP)will check such systems to be sure that they are reliable in performance and that their data is trustworthy.The Principal Investigator in a study is responsible for the quality of all computer systems used to meet the study protocol and for the quality and trustworthiness of all trial data collected either by paper or computer.