CLINICAL DATA MANAGEMENT TRAINING | BioMed Informatics Medwin Hospitals, Hyderabad, India

• Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
• Creation and maintenance of global library objects like DVGs Questions, Question groups, DCMs and DCIs
• Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
• Generating and Testing data entry screens and validate the range, format, date, missing fields
• Conduct study start up activities, like Study design and Defining Sites, investigators and patients
• Creating, generating and testing Data Validation and Derivation procedures
• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol
• Performing User Acceptance Testing (UAT)
• Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison Reconciliation and Update
• Test and execute validation procedures (Both single and batch validation)
• Discrepancy management and Query management
• Generating queries based on validation checks to clarify and improve the quality of the data
• Creating DCFs and maintaining Discrepancies
• Resolving queries and updating the database.
• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate.
• Improving the quality of the data to ensure an error free, accurate data with no open queries
• Establishing and coordinating the timely completion of the database lock procedures.
• Reviewing clinical data as per SOP, protocol, and study specific guidelines
• Knowledge of Data Extract and SAS extract views
• Maintaining Lab ranges, Lab units, Lab test questions
• Data entry in RDC and Discrepancy Management in RDC

• International Network of Clinical Data Management Associations (INCDMA) aims at the promotion of collaboration among clinical data management groups around the world. It is an international forum for discussion of and feedback on current topics of relevance to the discipline of CDM. It is composed of members the boards of the SCDM, ACDM (UK), DMB (France), PSDM (The Netherlands) who participate in the INCDMA proceedings and funding. It also regroups DM leaders and subject matter experts from Europe, North America, Israel, Japan, China and Australia.
• The Association for Clinical Data Management (ACDM) is a global organization founded in 1987 to support professionals in the management of clinical data.
• The Society for Clinical Data Management (SCDM) is an international organization promoting quality and excellence in data management.
• The Association Francaise de Data Management Biomedicale (DMB) is a French data management organization created in 1995. Gathers data from data managers (anyone involved in data management activity for developing drugs) from the pharmaceutical industry, CROs, software vendors or universities.
• The French network of data managers in academic biomedical research (AcaDM) is a network founded in 2008 which aims to offer a space for reflection between experts in order to standardize and improve practices.

Global Clinical Data Management Regulations

Clinical Data Management (CDM) involves the collection, cleaning, and management of clinical trial data to ensure its accuracy, integrity, and regulatory compliance. CDM regulations are typically aligned with Good Clinical Practice (GCP) and international guidelines such as those issued by the International Council for Harmonisation (ICH). Below is an overview of CDM regulations and frameworks globally, categorized by region and country.

Oceania

Australia
• Agency: Therapeutic Goods Administration (TGA)
• Framework:
• Follows GCP guidelines.
New Zealand
• Agency: MEDSAFE
• Framework:
• Aligns with ICH GCP E6(R2) for data integrity and trial conduct.

North America

United States
• Agency: Food and Drug Administration (FDA)
• Framework:
• Adherence to 21 CFR Part 11 (Electronic Records and Signatures).
• Follows FDA guidance on clinical trial data integrity, ensuring accuracy.
Canada
• Agency: Health Canada
• Framework:
• Complies with GCP guidelines.
• Complies with Canada's requirements for data integrity.

Europe

European Union
• Agency: European Medicines Agency (EMA)
• Framework:
• Clinical data management follows GCP.
United Kingdom
• Agency: Medicines and Healthcare Products Regulatory Agency (MHRA)
• Framework:
• CDM systems must adhere to GCP and MHRA guidelines.
• Germany, France, and Italy, align with EMA and local data protection laws.

Asia

India
• Agency: Central Drugs Standard Control Organization (CDSCO)
• Framework:
• Follows ICH GCP guidelines and Schedule Y of the Drugs and Cosmetics Rules.
China
• Agency: National Medical Products Administration (NMPA)
• Framework:
• Complies with GCP and Chinese data protection regulations.
• Emphasizes rigorous validation of CDMS and data traceability.
Japan
• Agency: Pharmaceuticals and Medical Devices Agency (PMDA)
• Framework:
• Requires compliance with ICH GCP and local regulations.

Middle East

Saudi Arabia
• Agency: Saudi Food and Drug Authority (SFDA)
• Framework:
• Follows ICH GCP and SFDA guidelines for clinical trials.
United Arab Emirates
• Agency: Ministry of Health and Prevention (MOHAP)
• Framework:
• Aligns with ICH GCP standards and ensures data protection.

Africa

South Africa
• Agency: South African Health Products Regulatory Authority (SAHPRA)
• Framework:
• Compliance with GCP and emphasizes ethical and accurate data handling.
Nigeria
• Agency: National Agency for Food and Drug Administration and Control (NAFDAC)
• Framework:
• Follows local GCP guidelines and emphasizes the integrity of clinical trial data.

Global Clinical Data Management Salaries

Clinical Data Management (CDM) salaries vary depending on region, experience, and employer type (pharmaceutical companies, CROs, hospitals, or academic institutions). Here’s a general overview of global CDM salaries:

North America

USA:
• Entry-level: $50,000-$70,000 per year
• Mid-level: $80,000-$110,000 per year
• Senior-level: $120,000-$180,000+ per year
Canada:
• Entry-level: CAD 45,000-CAD 60,000 per year
• Mid-level: CAD 70,000-CAD 90,000 per year
• Senior-level: CAD 100,000-CAD 150,000+ per year

Europe

United Kingdom:
• Entry-level:   22,000-  35,000 per year
• Mid-level:   40,000-  70,000 per year
• Senior-level:   75,000-  120,000+ per year
Germany/France/Netherlands:
• Entry-level:   30,000-  45,000 per year
• Mid-level:   50,000-  80,000 per year
• Senior-level:   90,000-  150,000+ per year

Asia-Pacific

India
• Entry-level  3,00,000-  5,00,000 per year
• Mid-level  6,00,000-  12,00,000 per year
• Senior-level  15,00,000-  30,00,000+ per year
Japan
• Entry-level   3,500,000-  5,500,000 per year
• Mid-level   6,000,000-  10,000,000 per year
• Senior-level   12,000,000-  20,000,000+ per year
Australia
• Entry-level AUD 45,000-AUD 65,000 per year
• Mid-level AUD 75,000-AUD 120,000 per year
• Senior-level AUD 130,000-AUD 200,000+ per year

Middle East

UAE
• Entry-level: AED 100,000-AED 160,000 per year
• Mid-level: AED 170,000-AED 300,000 per year
• Senior-level: AED 350,000-AED 500,000+ per year
Saudi Arabia
• Entry-level: SAR 90,000-SAR 140,000 per year
• Mid-level: SAR 150,000-SAR 250,000 per year
• Senior-level: SAR 300,000-SAR 450,000+ per year

Africa

South Africa
• Entry-level: ZAR 250,000-ZAR 400,000 per year
• Mid-level: ZAR 500,000-ZAR 900,000 per year
• Senior-level: ZAR 1,000,000-ZAR 1,800,000+ per year
Nigeria/Kenya/Ghana
• Entry-level: $10,000-$20,000 per year
• Mid-level: $25,000-$40,000 per year
• Senior-level: $50,000-$80,000+ per year