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"Clinical Data Management" is no longer available

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Course type: Online Instructor led Course

Platform: Link will be sent to the students email id, they have to click on the link and get connected

Course ID: 6932

Course type: Online Instructor led Course

Platform: Link will be sent to the students email id, they have to click on the link and get connected

Dr. Smita Singh picture
Dr. Smita Singh
No Reviews Yet

About the Course

The CDM program is an industry integrated program wherein the students will undergo classroom training as well as mandatory internship in a leading U.S Based CRO

Topics Covered

? Drug Development Process
? Introduction to Clinical Research
? Types of Clinical Trials
? Phases of Clinical Trials
? History & Regulations in CR
? ICH-GCP
? IRB/IEC
? Clinical Trial Protocol
? Terminologies & definition of C.trials
? Introduction to CDM
? Study set-up
? Introduction to Clinical Database
? Documents, guidelines used in CDM
? Data Entry
? HANDS ? ON TRAINING AS applicable
PROJECT WORK (Clinical Study)
As applicable
? Data Review/Data Validation &
Query Management
? Database QC
? CRF Design (Introduction)
? Database Design (Introduction)
? Edit Check & Edit Check Testing
? UAT (User Acceptance Testing)
? SOPs
? Quality Assurance, Audits
? PDP & Soft skills training
? Job Interview Preparation

Who should attend

After completing Bachelor?s / B.A.M.S / B.H.M.S / B.Tech (Biotechnology) / Pharmaceutical Science) / M.Sc. / M.Pharmacy

Pre-requisites

Applicants are recommended to have one of the following Life Science degree

Bachelor?s / B.A.M.S / B.H.M.S / B.Tech (Biotechnology) / Pharmaceutical Science) / M.Sc. / M.Pharmacy

What you need to bring

The broad band connection (512kbp)
Head Set

Key Takeaways

Training program participants should be able to

? Understand the high specific requirements and intent of CDM.
? Understand requirement for Good Laboratory Practices.
? Understand how the requirements should be implemented within your organization.

Date and Time

Not decided yet.

About the Trainer

Dr. Smita Singh picture

Avg Rating

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Students

Courses

Dr. Smita Singh

Bachelors of Dental surgery from Christian Medical College (C.M.C), Ludhiana.

I have more than seven years of experience in clinical Industry. A remarkable experience in working with large hospitals like Christian Medical College and other leading research institutions in India, especially in handling Clinical Dentistry, Hospital Management.
I gained excellent patient handling skills, with overall responsibility of diagnosis, prevention, treatment, patient follow-up, data management, patient consultation.

Having Excellent knowledge in Clinical trials, phases of clinical trial, IND, NDA, Protocol, review of various clinical trials protocol and source documents CRF, and design of CRF, Database design, Data entry, Data management, Data validation, Data coding, Data analysis, Quality, assurance and Quality control.

I believe in continuous improvement and have incorporated new teaching methodologies and integrated practical learning opportunities. And also contributed to generate awareness about clinical research by conducting seminars in various institutes.

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