Clinical internship

Duration

1-1.5 hours/online and 1-1.5 hours/on-site; one day a week; for 7 weeks Or 6 months, conducted on weekends (weekends: Saturday & Sunday- 6 to 8 hours)

Topics Covered

I. CDISC Specifications and FDA Requirements

  • CDASH, Study Data Standardization Plan and Submission Data Standards
  • SDTM and ADaM – Specifications
  • Metadata files and Control Terminology
  • DEFINE.PDF, DEFINE.XML, ODM-XML and Data-XML file

II. Understanding Concepts and Applying Mapping Plan

  • CDSIC MindMaps and References
  • Compare and Contrast SDTM and ADaM Steps
  • ADaM Models – ADSL, BDS and ODS
  • SDTM and ADaM 80/20 Mapping Rule
      i. 80% General Variables

 

      1.SDTM – Apply one of seven mapping methods

 

    2.ADaM – Analysis Variables, Imputation Methods, Baseline Identification, Visit Windows and Unscheduled Visits
      ii. 20% Special Variables

 

      1. SDTM – SUPPXX

 

    2. ADaM – DTYPE, Other e.g. ADVSLT
      iii. ADaM and SDTM Mapping Variables

    • ISO8601 Dates, Partial Dates, Durations and Periods
    • ODM-XML file structure and content

i.Global Element Order
ii.Understanding Tagsets
iii.Components – Metadata, Clinical Data, Administrative, Reference and Audit

III. QC, QA and Best Practices to establish Controls and Quality

  • Study Validation Checklists
  • SDTM and ADaM QC Forms
  • Tools to create and validate ODM-XML File
  • OpenCDISC and SAS Clinical Standard Toolkit
  • Templates – SDTM & ADaM Specifications, Defaults, Master SDTM to ADaM Map
  • ISS/ISE – Master Control Terminology

IV. FDA’s Review Process and Issues

    • Understanding the FDA Review process and preventing delays

i.FDA’s High Expectations

    • Understanding how to avoid FDA Review issues

i.Challenges

    • Sponsor’s Best Practices for better FDA Submissions

i.Lessons learnt

V. Student Presentation

Eligibility

Candidates should be trained in SAS® with following educational qualification (preferably).

  • Life sciences (M.Pharm., B.Pharm., M.Sc.)
  • Statistics (B.Sc., M.Sc.)
  • BE /BTech (Biotechnology,Bioinformatics,Computer Science)
  • MBBS, BDS, BHMS and BAMS

Access to SASSavvy.com

  • During the live online sessions with the US Instructor, which will be hosted onsite in India, students can ask questions. It is expected that students already have a general understanding of SAS clinical programming and clinical trials.
  • Through SASSavvy.com, students have 24/7 access to recorded online class sessions as well as resources to prepare for the clinical trials certification exam.
  • Students will create SDTM and ADaM SAS datasets by running CDISC SAS macros that access metadata files.
  • Student presentations and code reviews help to reinforce student understanding of key concepts.
  • At the end of each section, students complete hands-on exercises and answer a set of technical questions which are then reviewed during the following class session. There will be interactions with the online and onsite instructors.
  • At the completion of this course, students will get a certificate of completion as well as the CDISC e-guide for reference.

Upon completion of this training, you will be able to:

      Utilize metadata to automatically assign variable attributes in SDTMs and ADaMs

    • Understand the differences between the four different variable roles and three different variable types
    • Create and process ISO8601 dates, hierarchy of adverse events variables, paired lab variables, as well as lab visit window techniques
    • Apply effective techniques for using PROC TRANSPOSE to create and merge SUPPXX datasets with SDTMs to create ADaMs
    • Understand key differences between LB and ADLB dataset structure and content
    • Apply Proc SQL technqiues to identify the lab baseline values
    • Apply SDTM validation checklists to assure FDA compliance
    • Be better prepared for the SAS Clinical Trials Certification exam

Batch Size

10 participants per batch

Features of the Course

CDISC Mapping and Strategies Online Course offered by Cytel’s Clinical Programming Laboratory (CliPLab) teaches SAS programmers essential concepts about creating and validating SDTM (v 3.1.2 IG) and ADaM (v 1.0 IG) variables in key CDISC datasets (DM, AE, LB, ADSL, ADAE, and ADLB). Attendees learn how to create and process ISO8601 dates, hierarchy of adverse events variables and paired lab variables. Examples of both SDTM and ADaM dataset structures will be reviewed and compared. To help assure higher quality clinical data, a qc checklist and some key edit check macros will also be introduced. Students get a copy of all SAS macros reviewed in class. Also included is a one month free trial membership to SASSavvy.com for making smarter SAS searches. For a discounted fee, students will have an option to extend their SASSavvy.com membership for continued CDISC support.
The course is designed and delivered by Sunil Gupta, a veteran in the Pharmaceutical Industry with extensive experience as a Statistical Programmer and Mentor. Sunil is currently employed as an Associate Director, Statistical Programming with Cytel Inc.

Further Information

      • Course updated as on SEPTEMBER 2015
      • For batch schedule & course fee kindly contact us at respective locations or email us at info@cliplab.co.in

Mode of Payment

      • Payment can be done by Cheque/DD/Credit Card/Debit card
      • Installment facility available
      • Discounts available on full fees payments