About the Course
To impart practical training on clinical research/Data Management / SAS / CDISC-SDTM/CDISC-ADAM as per ICH GCP Guidelines, Local regulatory guidelines and ethical guidelines and other applicable standards and provide ‘INDUSTRY READY RESOURCES’ to the clinical research industry and there by contribute towards developing India as the most favorable destination for CLINICAL RESEARCH / DATA MANAGEMENT outsourcing for all Pharmaceutical AND Cro Industry across the world.
We understand the exact requirement of the Clinical Research Industry for their need of the trained manpower as we have experience working with Clinical Research Industry since 12 years handling Clinical Trials, Clinical Data Management, SAS, Pharmacovigilance , CDISC SDTM, CDISC ADAM, Drug Regulatory Affairs etc.
With the experience working with CRO’s, we have designed each training module focusing to expose the students practically to each task with logical exercises covering all the areas of Clinical Trials and Clinical Data Management, CDISC-SDTM and SAS.
Highly experienced staffs (SME’s) from clinical research and data management industry will only will involved in training the candidates with hands on experience on various areas of Clinical Data Management, SAS, CDISC-SDTM/ADAM.
Institute of Good Clinical Practice (iGCP) provide training in two different modes like Class Room, Online-learning.
Topics CoveredCLINICAL RESEARCH/CLINICAL TRIAL MANAGEMNT
• CLINCIAL RESEARCH HISTORY
• ICH GCP GUIDELINES
• PRE CLINICAL RESEARCH
• TRIAL DESIGN
- INTERPRETATION OF TIME & EVENT SCHEDULE
• E2A GUIDELINES
• E2B GUIDELINES
• INVESTIGATOR BROCHURE
• INFORM CONSENT
• SOURCE DOCUMENTS
• TRIAL MASTER FILES
• ETHICS COMMITEE
• SITE FEASIBLITY
• SITE INITIATION
• SITE MONITORING
• SITE CLOSE OUT
• ROLES OF INVESTIGATOR, CRC, CRA, SPONSOR
• WALK THROUGH THE STEPS FROM SUBJECT RECRUITMENT TO SUBJECT COMPLETION OF STUDY WITH REAL TIME SCENARIO’S.
CLINICAL DATA MANAGEMENT
Who should attendB.SC/M.SC In microbiology,All life science students
Pre-requisitesBasic Knowledge is required
What you need to bringPEN,BOOK"
Key TakeawaysGCP Training
FDA and DCGI guidelines
edit check programming
CDISC ADAM training
SDTM mapping training
SAS SDTM training
online sdtm training