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
CDISC (Clinical Data Interchange Standards Consortium) standards, including SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and TLF/TLGs (Tables, Listings, and Figures), are integral to regulatory submissions in clinical research. These standards are widely adopted globally to ensure consistency, transparency, and traceability of clinical trial data. Below is an overview of their regulatory context worldwide:
Oceania
Australia
- Agency: Therapeutic Goods Administration (TGA)
- Framework:
- SDTM datasets are recommended for tabulation data.
- ADaM datasets are preferred for analysis.
New Zealand
- Agency: MEDSAFE
- Framework:
- Adheres to ICH guidelines.
North America
United States
- Agency: Food and Drug Administration (FDA)
- Framework:
- CDISC SDTM and ADaM standards.
- 21 CFR Part 11.
- TLFs/TLGs are expected to be aligned with CDISC ADaM datasets.
Canada
- Agency: Health Canada
- Framework:
- CDISC standards.
Central/South America
Brazil
- Agency: ANVISA (AgenciaNacional de Vigilancia Sanitaria)
- Framework:
- CDISC standards to align with global regulatory expectations.
Mexico
- Agency: COFEPRIS
- Framework:
- Follows international GCP guidelines.
Europe
European Union
- Agency: European Medicines Agency (EMA)
- Framework:
- SDTM and ADaMfor electronic data submissions under EMA.
- Compliance with ICH E3 and E9 guidelines for statistical analysis.
- TLFs/TLGs must align with ADaM datasets.
United Kingdom
- Agency: Medicines and Healthcare Products Regulatory Agency (MHRA)
- Framework:
- Aligns with EMA guidelines, promoting the use of CDISC standards.
Asia
India
- Agency: Central Drugs Standard Control Organization (CDSCO)
- Framework:
- Supports CDISC-compliant submissions for global harmonization.
- Validation of SDTM and ADaM datasets is critical for regulatory approval.
China
- Agency: National Medical Products Administration (NMPA)
- Framework:
- Mandates CDISC standards for electronic clinical data submissions.
- SDTM is required for raw data, and ADaM is essential for analysis datasets.
Japan
- Agency: Pharmaceuticals and Medical Devices Agency (PMDA)
- Framework:
- SDTM and ADaM datasets for electronic submissions.
- Specific guidance is provided for creating compliant TLFs/TLGs.
Middle East
Saudi Arabia
- Agency: Saudi Food and Drug Authority (SFDA)
- Framework:
- Promotes the use of CDISC standards in alignment with ICH GCP.
United Arab Emirates
- Agency: Ministry of Health and Prevention (MOHAP)
- Framework:
- Encourages CDISC compliance to facilitate global harmonization.
Africa
South Africa
- Agency: South African Health Products Regulatory Authority (SAHPRA)
- Framework:
- Adheres to ICH guidelines and supports CDISC standards for clinical trial data.
Global CDISC SDTM ADaM TLF/TLGs Salaries
Salaries for professionals skilled in CDISC SDTM, ADaM, TLF/TLGs (Tables, Listings, Figures) vary widely based on location, experience, industry, and demand. Here's a breakdown by region and role:
North America
USA:
- Entry-level: $65,000-$85,000/year
- Mid-level: $90,000-$125,000/year
- Senior-level: $130,000-$180,000+/year
Canada:
- Entry-level: CAD 55,000-CAD 75,000/year
- Mid-level: CAD 80,000-CAD 110,000/year
- Senior-level: CAD 120,000-CAD 160,000+/year
Europe
United Kingdom
- Entry-level: £28,000-£45,000/year
- Mid-level: £50,000-£75,000/year
- Senior-level: £80,000-£130,000+/year
Germany/France/Netherlands
- Entry-level: £35,000-£50,000/year
- Mid-level: £55,000-£85,000/year
- Senior-level: £90,000-£140,000+/year
Asia-Pacific
India:
- Entry-level: ₹5,00,000-₹7,00,000/year
- Mid-level: ₹8,00,000-₹15,00,000/year
- Senior-level: ₹18,00,000-₹30,00,000+/year
Japan:
- Entry-level: ¥4,000,000-¥6,000,000/year
- Mid-level: ¥7,000,000-¥10,000,000/year
- Senior-level: ¥12,000,000-¥18,000,000+/year
Australia:
- Entry-level: AUD 55,000-AUD 75,000/year
- Mid-level: AUD 80,000-AUD 120,000/year
- Senior-level: AUD 130,000-AUD 200,000+/year
Middle East
UAE:
- Entry-level: AED 130,000-AED 180,000/year
- Mid-level: AED 200,000-AED 300,000/year
- Senior-level: AED 350,000-AED 500,000+/year
Saudi Arabia:
- Entry-level: SAR 110,000-SAR 160,000/year
- Mid-level: SAR 170,000-SAR 250,000/year
- Senior-level: SAR 300,000-SAR 450,000+/year
Africa
South Africa:
- Entry-level: ZAR 350,000-ZAR 500,000/year
- Mid-level: ZAR 550,000-ZAR 850,000/year
- Senior-level: ZAR 1,000,000-ZAR 1,800,000+/year
Nigeria/Kenya/Ghana:
- Entry-level: $15,000-$25,000/year
- Mid-level: $30,000-$50,000/year
- Senior-level: $60,000-$90,000+/year