Data Management Unit Research Institute for Health Sciences, Chiang Mai University

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1 Data Management Unit Research Institute for Health Sciences, Chiang Mai University

2 Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data management system is to produce quality data Clinical data management is a multidisciplinary effort that consists of various activities involving the handling of data or information that is outlined in the protocol that will to be collected/analyzed

3 A multi-disciplinary activity that includes: Research nurses Clinical data managers Investigators Support personnel Biostatisticians Database programmers

4 Activities involving the handling of information outlined in protocol Clinical Database Design / Application Development Data Acquisition/Collection Data Processing/Coding Data tracking Data Entry Data Cleaning Data Analysis Data Transmission Data Storage Data Privacy Data QA

5 At the conclusion of this module, you will be able to: Discuss what constitutes data management activities in clinical research. Identify regulations and guidelines related to data management practices. Describe what a case report form is and how it is completed.

6 Source data are generated (e.g. clinical site medical records, laboratory results, and patient diaries) Clinical site records are transcribed onto Case Report Forms (CRFs) CRFs are entered into the clinical trial database The data are checked for accuracy, quality, and completeness. Discrepancies may be tested electronically or manually. Some discrepancies will turn into queries to the clinical site The database is locked when the data are considered final The data are reformatted for reporting and analysis The data are analyzed and the analysis results are reported The database and other study data are archived

7 Responsible for executing the design, documentation, testing and implementation of data collection system and processes to support of the study teams. Assist with development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standard. Designs and creates Case Report Forms to ensure data will support the study objectives. Initiation and management of the data clarification process, coordinating with study teams to ensure appropriate resolution to all data clarifications prior to data locked.

8 Implementation of quality, efficient and consistent approaches to carrying out data management tasks. Analyzes, summarizes and presents data from routine studies. Delivering training to data management and other units, as necessary. Conduct data management activities in compliance with all relevant regulations, ICH, CFR guidelines as well as all policies and procedures.

9 Source documents need to be accurate and complete Data abstraction should occur in real time QC/QI is the responsibility of every research team member QC/QI should be completed on all protocol data for all protocols QC/QI should be proactive and ongoing Each team member should know and understand the roles and responsibility of each team member * QC - Quality Control, QI Quality Improvement

10 Data management plan (DMP) describes the activities to be conducted in the course of processing data: Details how data will be: Collected Stored Managed Archived Describes and defines all data management activities for a study: What Who When How

11 Development begins after the protocol and Case Report Forms are drafted Should be completed before the study begins Must be kept current reflect important changes to the data management process and computer systems that took place during the study

12 Protocol Summary Study Personnel / Roles CRF Design / Tracking Database Development Data Entry and Processing Data Cleaning Reports Audit Plan External Data Transfers Managing Lab Data SAE Handling Coding Training Study Closeout

13 Forces planning Process and tasks become more visible to the project team Expected documents are listed at the start of the study so they can be produced during the study Provides continuity of process and a history of a project Useful for long-term studies Useful for personnel turnover and growing DM groups Regulatory Requirement Auditors will ask for it

14 Planning upfront saves time at end and improves data quality First DMP is time-consuming to do Use templates and previous DMPs to ease upfront burden Development of the Data Management Plan is so important that the DMC is recommending tracking of the percent of studies for which a DMP was written prior to first patient enrolled. Useful for personnel turnover and growing DM groups

15 Good Clinical Practice (GCP): Trial management; data handling, record keeping (2.10, a-d) Subject and data confidentiality (2.11; g) Safety reporting (4.11) Quality control (4.9.1; 4.9.3; 5.1.3) Records and reporting (5.21; 5.22) Monitoring (5.5.4)

16 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: a) Ensure and document that the electronic data processing system(s) conforms to the sponsor s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation). b) Maintains SOPs for using these systems. c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail). d) Maintain a security system that prevents unauthorized access to the data.

17 2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s) g Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing).

18 4.11 Safety Reporting All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).

19 4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

20 5.21 Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority (ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s) Clinical Trial/Study Reports Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)

21 5.5.4 If data are transformed during processing, it should always be possible to compare the original data and observations with the processed data.

22 21 CFR Part 11 Applies to all data (residing at the institutional site and the sponsor s site) created in an electronic record that will be submitted to the FDA Scope includes: validation of databases audit trail for corrections in database accounting for legacy systems/databases copies of records record retention

23 In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by 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. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA s responsibility to protect the public health.

24 If data are being captured in an electronic system with no paper CRFs then should(must) use compliant system System can be compliant but user must follow standard procedures to assure total process is compliant At minimum, use system with audit trails

25 Guidelines for Good Clinical Practice. International Conference on HarmonisationI(ICH). FDA, Title 21CFR Part11 /cfcfr/cfrsearch.cfm?cfrpart=11

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