Clinical Research Training​

Post Graduate Diplomas in Clinical Research, Data Management and Biostatistics

The Diploma in Clinical Research and Clinical Data Management is jointly run three times a year by two premier institutions in the field of Clinical Research, PPCE & Ruby Hall Clinic.

Designed to turn Life Sciences graduates into well-rounded, thinking individuals who will add value to the companies who hire them, the course includes a balance of theory, practicals and honing of soft skills that will increase your chances of employability.

Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug. The clinical trials conducted all over the world follow universally accepted guidelines and regulations. These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical studies and which have an approval from the required health and ethical authorities.

We desire that you enjoy this course, learn from it and gain experience from the

hands-on activities which will give you a feel of working in a live setup. It is our aim that you increase the pool of bright, enthusiastic and knowledgeable students who will enter the healthcare industry and make its future even brighter.

Module 1 – Clinical Research

  • Introduction to Clinical Research

  • History and evolution in Clinical research

  • Introduction to Pharmaceuticals

  • Drug Discovery and Development

  • II Practical Aspects in Clinical Research

  • Clinical Research process flow

  • Stakeholders in clinical research

  • Essential documents

  • Bioethics in clinical research

  • Pharmacovigilance

  • QA in Clinical Research

  • SMV, Audit, Inspections and Quality Assurance in Clinical research

  • IV Regulatory Affairs in Clinical Research

  • Regulatory Authorities involved in Clinical Research

  • Statutory Guidelines in Clinical Research

  • Regulatory Submission

  • Career pathways in Clinical Research

Module 2 – Clinical Data Management

  • Overview to Data Management

  • Protocol Review

  • Data Management Plan

  • CRF Designing

  • Database Designing and User Acceptance Testing

  • Edit Check Designing and Validation

  • CRF Tracking and Data Entry Processes

  • Data Validation & Query Writing

  • Medical Coding

  • Serious Adverse Event Reconciliation

  • Laboratory Data Handling

  • Database Closure

  • Data Management Regulations

  • Overview to Electronic Data Capture

  • Practicals on DM Applications

  • Activities/Assignments 

TESTIMONIALS

Just a quick note to say thank you very much to everyone at PPCE.   The experience has been filled with variety.

 

Clinical Data Management training and internship gives a good understanding and hands on expertise for a career in the Clinical Research industry.

SHIKHA MALLA (M.SC. MICROBIOLOGY)

IBM PUNE

© 2020 PPCE

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