Online Training - CDISC SDTM, ADaM, TLF/TLGs with Project Experience Certification & Placement Assistance
BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best CDISC SDTM, ADaM, TLF/TLGs Training in Hyderabad since the year of 2000. Online CDISC SDTM, ADaM, TLF/TLGs Training in Hyderabad, India includes best CDISC SDTM, ADaM, TLF/TLGs Training online Institute that imparts knowledge about the process of Submission of Standardised Data as per US FDA Guidelines from clinical research. CDISC SDTM, ADaM, TLF/TLGs certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best CDISC SDTM ADaM TLF/TLGs Training in USA, best CDISC SDTM ADaM TLF/TLGs Training in UK, best CDISC SDTM ADaM TLF/TLGs Training in Australia, best CDISC SDTM ADaM TLF/TLGs Training in Germany, best CDISC SDTM ADaM TLF/TLGs Training in Sweden, best CDISC SDTM ADaM TLF/TLGs Training in Netherlands, best CDISC SDTM ADaM TLF/TLGs Training in Singapore, best CDISC SDTM ADaM TLF/TLGs Training in Europe, best CDISC SDTM ADaM TLF/TLGs Training in Canada. Training in Online CDISC SDTM, ADaM, TLF/TLGs is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. CDISC stands for Clinical Data Interchange Standards Consortium and it is developed keeping in mind to bring great deal of efficiency in the entire drug development process. CDISC brings efficiency to the entire drug development process by improving the data quality and speed-up the whole drug development process and to do that CDISC developed a series of standards like Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). With the rising innovations and the rapid growth in healthcare sector, the demand for trained Professionals has been increased.
Online Training Features
- Web based classroom
- One faculty/student
- Placement support
- Regular/Fast track/Weekend individual slot
- Flexible timings
- Training Mode: Skype/Teamviewer
Certification
Course Certificate & Job Experience Certificate would be awarded at the end of the program.
Course Curriculum
- CDISC Efficient Programming to Generate SDTM, ADaM Datasets & (TLF/TLGs) (TABLES, LISTINGS AND FIGURES) Using SAS with Project
- CDISC Overview & Purpose of Creating SDTM, ADaM Data sets
- Raw Data Manipulation
- CRF : Explanation of Case Repot Form and why it is important for the study
- CRF Annotation
- DATASET CREATION OR EXTRACTION : Conversion of Raw data into SAS datasets or Exporting Data from Client Server for implementing various SAS procedures and methods for the creation of SDTM Dataset
- Classification of Domains
- > Special Purpose
- > Interventions
- > Events
- > Findings
- > Trial Design Model
- Types of variables (core) in SDTM and ADaM
- > Req (Required)
- > Exp (Expected)
- > Perm (Permissible)
- Code list
- Roles
- > Identifier
- > Timing
- > Topic
- > Qualifier
- . Record
- . Grouping
- . Synonym
- . Results
- . Variable
- > Rule Variables
- CLINICAL STUDIES
- TYPES OF STUDIES
- > Parallel
- > Cross Over
- .Phases of Clinical Trials
- .Blinding/Masking Explanation
- .Eligibility Criteria
- .Formats
- Flow of Clinical Trials Data
- SDTM
- SDTM IG
- SDTM SPECIFICATION
- SDTM DOMAINS
- > DM (Demographics) / Special purpose category
- > SV (Subject Visits) / Special purpose category
- > AE ( Adverse Events) /Events
- > MH (Medical History) /Events
- > EX (Exposure) /Interventions
- > CM (Concomitant/Prior Medications) / Interventions
- > LB (Laboratory Test Results) / Findings
- > VS (Vital Signs) /Findings
- SUPPQUAL (Supplementary Qualifiers)
- RELREC (Relate Records)
- SDTM Metadata
- SDTM Mapping
- Implementing CDISC SDTM with SAS
- SDTM Codelist Creation by SAS Programming
- SAS Programming in Building SDTM Datasets
- Creating SDTM Codelist SAS Format Catalog by SAS Programming
- Creating an Empty SDTM Domain Dataset by SAS Programming
- SAS Programming to Create an SDTM - DTC Date Variable
- Creating SDTM Study Day Variable by SAS Macro Programming
- Sorting the Final SDTM Domain Dataset by SAS Programming
- SAS Programming in Building the Special – Purpose DM and SUPPDM Domains
- SAS Programming in Building the AE Events Domains
- Building the EX Exposure Interventions Domain by SAS Programming
- Building the LB Findings Domains by SAS Programming
- SAS Programming in Building a Custom XP Findings Domain
- SAS Programming in Building the Trial Design Model (TDM) Domains
- eCRF ANNOTATION : Annotation of Case Repot Form with field description and into which SDTM variable is going to be mapped
- SDTM SPECIFICATION DEVELOPMENT/QC AS PER CLIENT GUIDELINES AND SDTM IG : Creation of Specification where all the information is present for SDTM dataset creation and the description of programming notes to specify how to map raw dataset variables to SDTM variables
- SDTM PROGRAM DEVELOPMENT SIDE : Where we can work on various implementation methods of variables creation and following SAS methods, procedures and other functions based on the need
- SDTM PROGRAM QC SIDE : Code creation for SDTM dataset by implementing various SAS methods
- COMPARE DEV AND QC DATASETS : By using compare methods - compare datasets and produce report and pinnacle report
- UPDATIONS IF NEEDED : As per compare report, doing any updations if needed
- ADaM
- ADaM IG
- ADaM SPECIFICATION
- ADaM Metadata
- Validation
- ADaM DOMAINS
- > ADSL (Subject Level Analysis Dataset)
- . Subject Level Analysis Flags
- . Population Flags
- . Criterion Flags
- > ADAE (Adverse Events Analysis Dataset) OCCDS
- > ADCM (Concomitant/Prior Medications Analysis Dataset) OCCDS
- > ADEX (Exposure Analysis Dataset) Other
- > ADLB (Laboratory Analysis Dataset) BDS
- > ADVS (Vital Signs Analysis Dataset) BDS
- > ADSL (Subject Level Analysis Dataset)
- Implementing CDISC ADaM with SAS
- SAS Programming in Building ADaM Datasets
- SAS Programming in creating ADSL- THE SUBJECT-LEVEL DATASET
- ADAE - ADVERSE EVENT ANALYSIS DATASET creation by SAS Programming
- SAS Programming in Creating ADaM BASIC DATA STRUCTURE (BDS)
- ADaM PROGRAM DEVELOPMENT SIDE
- ADaM PROGRAM QC SIDE
- COMPARE DEV AND QC DATASETS
- UPDATIONS IF NEEDED
- TLF/TLGs
- > GOING THROUGH MOCK SHELL : How the output report to be produced and the style of mock need to be implemented
- > DEVELOPING PROGRAM
- > DOING QC
- TABLES
- LISTINGS (Safety & Efficacy)
- FIGURES
- Tables, Listings, Figures/Graphs (TLF/TLGs) by using SAS Programming
LIVE CLINICAL SAS PROJECT
You will be extensively involved
- Creating CDISC SDTM datasets for domains from raw datasets
- Preparing ADaM datasets by SAS Programming
- Creating SDTM Domains by SAS Programming
- Writing code to extract, clean and validate data
- Applying transformation for Structuring and integration
- Querying the data by using SAS procedures, Functions & Merge statement
- Creating Macros for repeated programs
- Preparing Tables, Listings, Figures/Graphs (TLF/TLGs) by SAS Programming
- Developing SAS codes for SDTM Datasets and ADaMs based on the specification
- Writing SDTM and ADaM specification and creating annotated CRF
- Generating Clinical Reports in form of Tables and Graphs etc
- Validation
- Data manipulation and generating reports employing various SAS procedures
- Using SAS Macros and SAS programs to transform raw data into SDTM data for Statistical Analysis & Submission
Global CDISC SDTM ADaM TLF/TLGs Regulations
- Australia - Therapeutic Goods Administration (TGA)
- New Zealand - MEDSAFE
- North America
- Canada - Health Canada
- USA - FDA: Food and Drug Administration
- Central/South America
- Argentina - ANMAT
- Brazil - AgenciaNacional de Vigilancia Sanitaria (ANVISA)
- Chile - Instituto de SaludPublico (ISP)
- Columbia - InstitutoNacional de VigilanciaMedicamentos y Alimentos (INVIMA)
- Costa Rica - Ministerio de Salud
- Cuba - CECMED
- Dominican Republic - Direccion General de Drogas y Farmacias
- Jamaica - Ministry of Health
- Mexico - Comision Federal para la Proteccion contra RiesgosSanitarios (COFEPRIS)
- Paraguay - Ministro de SaludPublica y Bienestar Social
- Peru - Ministerio de Salud
- Uruguay - Ministerio de SaludPublica
- European Union - EMA: European Medicines Agency
- Armenia - Scientific Centre of Drug and Medical Technology Expertise
- Austria - Agency for Health and Food Safety (AGES)
- Belgium - Federal Agency for Medicines and Health Products
- Bulgaria - Bulgarian Drug Agency
- Croatia - Agency for Medicinal Products and Medical Devices of Croatia
- Cyprus - Ministry of Health
- Czech Republic - State Institute for Drug Control
- Denmark - Danish Medicines Agency
- Estonia - State Agency of Medicines
- Finland - Finish Medicines Agency
- France - AgenceNationale de Securite du Medicament et des Produits de Sante
- Germany - Federal Institute for Drugs and Medical Devices
- Georgia - Regulation Agency for Medical and Pharmaceutical Activities
- Greece - National Organisation for Medicines
- Hungary - National Institute of Pharmacy
- Iceland - Icelandic Medicines Agency
- Ireland - Irish Medicines Board
- Italy - National Institute of Health
- Lithuania - State Medicines Control Agency
- Luxembourg - Ministry of Health
- Malta - Maltese Medicines Authority
- Moldova - Medicines Agency
- Netherlands - Medicines Evaluation Board
- Norway - Norwegian Medicines Agency
- Poland - The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Portugal - National Authority of Medicines and Health Products
- Romania - National Medicines Agency
- Russia - Ministry of Health of the Russian Federation
- Serbia - Medicines and Medical Devices Agency of Serbia
- Slovakia - State Institute for Drug Control
- Slovenia - Ministry of Health
- Spain - Spanish Medicines Agency
- Sweden - Medical Products Agency
- Switzerland - Swiss Agency for Therapeutic Products
- Ukraine - Ministry of Health
- United Kingdom - Medicines and Healthcare Regulatory Agency (MHRA)
- Bahrain - I-SEHA
- Egypt - Ministry of Health
- Iran - Ministry of Health
- Israel - Ministry of Health
- Jordan - Jordan Food and Drug Administration
- Lebanon - Ministry of Public Health
- Saudi Arabia - Saudi Food and Drug Authority
- United Arab Emirates - Ministry of Health
- Bangladesh - Directorate General of Drug Administration (DGDA)
- Bhutan - Drug Regulatory Authority
- China - CFDA/NMPA: State Food and Drug Administration
- India - Central Drug Standards Control Organization (CDSCO)
- Indonesia - POM (PengawasObatdanMakanan)
- JAPAN - PMDA: Ministry of Health, Labour and Welfare
- Korea (South) - Korean Food and Drug Administration (KFDA)
- Laos - Food and Drug Department
- Malaysia - Ministry of Health (MOH)
- Nepal - Department of Drug Administration
- Philippines - Department of Health (DOH)
- Singapore - Health Sciences Authority (HSA)
- Sri Lanka - Ministry of Health (MOH)
- Taiwan (Republic of China) - Taiwan Food and Drug Administration (TFDA)
- Thailand - Food and Drug Administration of Thailand
- Vietnam - Drug Administration of Vietnam
- Algeria - Ministry of Health and Population
- Botswana - Ministry of Health (MOH)
- Burkina Faso - Le Ministere de la Sante
- Ghana - Food and Drugs Authority
- Kenya - Pharmacy and Poisons Board
- Morocco - Ministry of Health
- Nigeria - National Agency for Food and Drug Administration and Control
- Rwanda - Ministry of Health
- Senegal - Ministere de la Sante et de l'ActionSociale
- South Africa - Medicines Control Council (MCC)
- Swaziland - Ministry of Health
- Tanzania - Tanzania Food and Drug Authority (TFDA)
- Uganda - National Drug Authority