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INSTITUTE FOR CLINICAL RESEARCH and CLINICAL DATA MANAGEMENT COURSE

Dilsukhnagar, Hyderabad

30,000

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About the Course


OUR OBJECTIVE:

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.

ABOUT US:

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 Covered

CLINICAL RESEARCH/CLINICAL TRIAL MANAGEMNT

• CLINCIAL RESEARCH HISTORY
• ICH GCP GUIDELINES
• PRE CLINICAL RESEARCH
• PHASES
PHASE I
PHASE II
PHASE III
PHASE IV
• PHARMACOVIGILANCE
• PROTOCOL
• TRIAL DESIGN
- ARMS
- RANDOMIZATION
- BLINDING
- PARELLEL
- CROSSOVER
- INTERPRETATION OF TIME & EVENT SCHEDULE
• E2A GUIDELINES
• E2B GUIDELINES
• INVESTIGATOR BROCHURE
• INFORM CONSENT
• SOURCE DOCUMENTS
• LOGS
• 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 attend

B.SC/M.SC In microbiology,All life science students
B.PHARMA/M.PHARMA,B.DS ,NURSES

Pre-requisites

Basic Knowledge is required

What you need to bring

PEN,BOOK"

Key Takeaways

GCP Training
FDA and DCGI guidelines
CRF Designing
edit check programming
ADAM training
CDISC ADAM training
CDISC training
SDTM mapping training
SAS SDTM training
online sdtm training
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Course Id: 16813