Code of Ethics for CDM Professionals Clinical Data Management is a key component of the development of new medications, medical procedures & devices Clinical Data Management professionals are: Committed to following the laws & guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity & well being of patients & to maintain the confidentiality of medical records

Code of Ethics for CDM Professionals Committed to creating, maintaining & presenting quality clinical data, thus supporting accurate & timely statistical analysis, & to adhering to applicable standards of quality & truthfulness in scientific research Committed to facilitating communication between clinical data management professionals & all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, & to ensuring the dissemination of information to members of the clinical research team

Code of Ethics for CDM Professionals Committed to working as an integral member of a clinical research team with honesty, integrity & respect Committed to making & communicating accountability for clinical data management decisions & actions within the clinical trial process Committed to maintaining & respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, & to disclosing any conflict of interest

Code of Ethics for CDM Professionals Committed to avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management Committed to advancing the profession of clinical data management through the development, distribution & improvement of good clinical data management practices Committed to aiding the professional development & advancement of colleagues within the clinical trial industry

DATA MANAGEMENT TEAM Data management team comprises of physicians, pharmacy graduates, post-graduates, information technologists, biotechnologists, project managers, clinical programmers, clinical data specialists and life science graduates. They work in close collaboration with biostatistician, research co-ordinators, clinical staff, medical writers and regulatory agencies and other external contributors to ensure timely project deliverables.

Sponsor Responsible for signing off on the project. Reviews and approves budgets and scope changes, which have impact on cost, time and quality deliverables. Reviews and authorizes study documents.

Project Data Manger Primary contact person and will interact with the sponsor and sites to ensure the quality and timely consumption of study within the project plan. PDM will focus primarily on project specific training needs, resource allocation, milestone planning and tracking, leading and managing a cross functional team and ensuring that projects are progressing according to quality standards and SOP’s and regulatory guidelines.

Manager responsible for managing the collection/tracking of CFR’s responsible to allocate the data entry resources with various projects. Ensure the manpower is well trained before putting on live projects to minimize data entry errors. Also reviews the designed CRF’s and the validity of the data entry information.

Clinical data coordinator responsible for performing all data coordination activities and data validation on CDM projects. Also to ensure the completeness and validity of the clinical trial data that has gone through data entry. Responsible to review and resolve data discrepancies identified by the system or through manual checks as identified in the study validation plan.

Data entry Associate: Data coder responsible for keying (entering) the data into the database. He is also responsible for ensuring data quality process optimization and meeting CDM deliverables. Data coder responsible for coding of medical terms like adverse events, medical history etc…, responsible for resolution of coding issues with sponsor.

Database programmer Quality Associate responsible for gathering end user requirements, solutions to clients (internal & external), design, implementation and validation of database. Quality Associate responsible for ensuring data quality issues in end to end process of CDM by verifying study documents, project plans, quality process documents.