The data can be defined as any Information or fact which is related to the clinical trial. It can be figures, numeric values, medical history, medication records, examination reports and records and signatures. The data can be basically of three types, that is
i) Source data- the data obtained from the original Lab reports, pathology reports, surgical reports, physician progress notes, medical record, X-ray films, tumour measurements etc.
ii) Intermediate data which include CRF (Case Report Form), ICF (Informed Consent Form), Investigational Product (IP) accountability logs etc.
iii) Final data includes the final report
Data is collected at the site by the investigator, CRC, nurse, pharmacist, phlebotomist, monitor, CRA, auditor, etc. The data should be legible, indelible, timeliness or promptness, logical, consistent, completeness, accurate and credible. The data is significant and it is considered to be the huge asset for the sponsors, as plenty of the resources are invested. It serves as a basis for submission, approval, labeling and marketing of a product. The review and approval of new drugs by regulatory agencies is dependent upon a trust that clinical trial data presented are the sufficient integrity to ensure confidence in results and conclusions presented by pharmaceutical companies.
Clinical Data Management refers to the management of data capture and data flow processes in conduct of a clinical trial. It is a well defined, well designed and well controlled process of managing clinical trial data. It is considered as an integral, respected, highly valued member of clinical development team. The clinical data management has evolved from a data entry process into a diverse process. Now CDM manages entry of CRF data, merging of non-CRF data, systems and processes designed to identify the ill-processed data, generate and track CRF, determine the protocol violators and interact with the site personnel to resolve the data issue.
Code of ethics is determined by SCDM (Society for Clinical Data Management). According to this code of ethics, clinical data management professionals are committed to following the laws and guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity and well-being of patients and to maintain the confidentiality of medical records. They are committed to creating, maintaining and presenting quality data, thus supporting accurate and timely statistical analysis, and to adhering to applicable standards of quality and truthfulness in research. The professionals are committed to facilitating communication between CDM professionals and all other clinical research professionals to maintaining competency in all areas of clinical data management and they are committed in keeping current with technological advances; and to ensuring the dissemination of information to members of the clinical research team. The data management team are committed to working as an integral member of a clinical research team with honesty, integrity and respect; and to making, and communicating accountability for, data management decisions and actions within the clinical trial process and maintaining and respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, and to disclosing any conflict of interest. They are committed to avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession and helping the professional development and advancement of colleagues within the clinical trial industry.
Before starting the trial, the investigator and research team must address issues related to data management, including, data privacy, data storage, record keeping, data protection, data retention, destroying the data and sharing and reporting the data.
International Conference on Harmonization (ICH) has laid down some guidelines for clinical data management in its sections. Here, are few sections elaborating the guidelines required for data management. ICH-GCP 2.10, 4.9, 5.5, 5.14 and ICH E9 3.6 and 5.8 illustrates that all the clinical research data should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. ICH E6 5.1.1 determines the quality assurance and quality control systems with written standard operating procedures should be implemented and maintained to ensure that research are conducted and data are generated, documented, recorded and reported in compliance with the protocol, GCP and applicable regulatory requirements. According to ICH-GCP 5.5.4, if the data are transformed during processing, it should always be possible to compare the original data and observations with the processed data. Common standards should be adopted for a number of features of research such as dictionaries of medical terms, definition and timing of main measurements and handling of protocol deviations. (ICH E9 2.1.1). Protocol amendments that necessitate a change in design of CRF, subject diaries, study worksheets, research database and other key aspects of data management processes need to be controlled as per ICH E9 2.1.2.
Data Management Plan (DMP) serves as the backbone of overall quality system of data management. It helps to proactively assess and plan for study specific data management processes. DMP plans each and every step of data management, several tasks, responsibilities, deadlines of data management unit, the creation of documents, the standard operating procedure (SOP) or regulation to be followed for each activity, degree of quality to be achieved. The preparation, review and finalization of DMP involves participation of the sponsor, lead data managers, project managers, biostatisticians, database programmers, CRAs, medical monitor, laboratory directors, etc. The major elements of DMP include, protocol designing, roles and responsibilities of staff members on-site and off-site. The data flow diagram is drawn to understand the work in a better way. The case report form (blank and annotated), data validation methods, CRF tracking and discrepancy management are discussed under DMP.
This entire process is quite complex and move smoothly according to the plan. The act of Health Insurance Portability and Accountability Act (HIPAA) must be kept in mind before delivering the data to anyone. This act protects the right of the patient to keep their medical records hidden. The archiving procedure and project documentation should be strictly followed as per DMP. The quality and regulatory standards has to be met positively. The communication plan and assignment of responsibilities to different members should be guided according to the guidelines mentioned in the data management plan (DMP).
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